2,638 Clinical Research Manager jobs in the United States

Our client, a leading pharmaceutical company, is seeking a dedicated Clinical Research Manager to oversee critical research studies. This hybrid role offers a blend of remote flexibility and necessary in-office engagement, based in the scenic location of Denver, Colorado. You will be responsible for the planning, execution, and monitoring of clinical trials, ensuring adherence to protocols, regulatory guidelines, and quality standards. This position is vital for advancing medical knowledge and developing innovative pharmaceutical solutions.

Key responsibilities include managing clinical trial budgets, timelines, and resources effectively. You will oversee the selection and training of clinical research staff, and provide ongoing mentorship and performance management. This role involves close collaboration with investigators, study coordinators, regulatory bodies, and internal stakeholders to ensure smooth trial progression. You will be instrumental in developing study protocols, case report forms, and other essential trial documentation. Ensuring data integrity and accuracy, and managing adverse event reporting are critical aspects of the job. The ideal candidate will hold a Bachelor's or Master's degree in a life science, healthcare, or related field. A minimum of 7 years of experience in clinical research management, with a strong understanding of Good Clinical Practice (GCP) and relevant regulatory requirements (e.g., FDA, EMA), is essential. Experience managing multiple trials simultaneously and a proven ability to lead and motivate teams are highly desirable. Excellent organizational, communication, and problem-solving skills are required. If you are passionate about contributing to groundbreaking pharmaceutical research and possess the necessary expertise, we encourage you to apply. The hybrid work model supports operational needs within the vicinity of Denver, Colorado, US .

Our client is looking for a dedicated and experienced Clinical Research Manager to oversee and coordinate research studies in Salt Lake City, Utah, US . This role offers a hybrid work model, blending on-site collaboration with remote flexibility. You will be responsible for managing all phases of clinical trials, from protocol development and site initiation to data analysis and study closeout, ensuring adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements. Key responsibilities include developing study protocols, managing budgets, and ensuring the timely recruitment of participants. You will supervise and train research staff, including coordinators and nurses, ensuring they are proficient in study procedures and documentation. This position requires a strong understanding of ethical considerations in research and the ability to navigate complex regulatory landscapes (e.g., FDA, IRB). You will liaise with investigators, sponsors, and regulatory authorities, ensuring clear communication and timely reporting of study progress and any adverse events. Data management, quality assurance, and compliance monitoring are critical aspects of this role. The ideal candidate will possess a Bachelor's or Master's degree in a health science field (e.g., Nursing, Pharmacy, Public Health) or a related discipline, with at least 5-7 years of experience in clinical research, including significant experience in a management or supervisory capacity. Certification as a Clinical Research Professional (e.g., CCRP, CCRC) is highly desirable. Excellent organizational, problem-solving, and communication skills are essential. You must be adept at managing multiple projects simultaneously and thrive in a collaborative, yet independent, work environment. If you are passionate about advancing medical knowledge and improving patient care through rigorous research, this role provides a vital opportunity to contribute.

**Job Description**
The Clinical Trials Manager for Psychiatry works closely with the Vice Chair for Clinical Research to support the coordination and execution of investigator-initiated and industry-sponsored clinical trials within the Department of Psychiatry at Icahn School of Medicine at Mount Sinai. The Clinical Trials Manager will work to ensure the operational success and regulatory compliance of a growing portfolio of research studies focused on mental health, including mood disorders, psychosis, anxiety, PTSD, and neurodevelopmental conditions. The manager will provide leadership to a multidisciplinary team of coordinators and research staff, ensuring compliance with institutional policies, ethical standards, and regulatory requirements.
**Qualifications**
- Bachelor's degree in psychology, neuroscience, public health, nursing, or related field required; Master's degree (e.g., MPH, MS, MSW, RN, or related) preferred.
- Minimum 5 years of clinical research experience, with at least 2 years in a trials management role, preferably in psychiatry or behavioral health.
- Thorough understanding of ethical and operational considerations in mental health clinical research, including work with vulnerable populations and cognitively impaired individuals.
- Experience with IRB and regulatory submissions in an academic setting.
- Familiarity with psychiatric rating scales (e.g., HAM-D, MADRS, PANSS, CAPS) and structured clinical interviews is preferred.
- Proficiency in electronic data capture systems (e.g., REDCap, Medidata, or equivalent) and clinical trial management systems (CTMS).
- Certification through ACRP, SOCRA, or equivalent preferred.
- Strong leadership, organizational, and interpersonal communication skills.
- Demonstrated commitment to advancing evidence-based care and improving outcomes for individuals with mental illness.
**Responsibilities**
- Support the day-to-day operations of psychiatric clinical trials, including recruitment, informed consent, data collection, and protocol adherence.
- Serve as a primary point of contact for investigators, sponsors, IRB, and institutional leadership on psychiatry research studies.
- Oversee development of study protocols, case report forms (CRFs), source documents, and standard operating procedures (SOPs).
- Supervise, mentor, and evaluate clinical research coordinators and assistants supporting psychiatric trials.
- Monitor and report on study metrics, enrollment targets, and regulatory timelines; proactively identify and address barriers to recruitment and retention in psychiatric populations.
- Ensure compliance with Good Clinical Practice (GCP), FDA regulations, ICH guidelines, HIPAA, and IRB requirements specific to mental health research.
- Supervise and support the preparation and submission of IRB applications, amendments, continuing reviews, and adverse event reports.
- Participate in the negotiation and management of study budgets and contracts.
- Coordinate and facilitate site initiation visits, monitoring visits, and sponsor audits with a focus on mental health research standards and best practices.
**About Us**
**Strength through Unity and Inclusion**
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
**About the Mount Sinai Health System:**
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
**Equal Opportunity Employer**
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.
**Compensation Statement**
Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $71713 - $ Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

Our client, a renowned healthcare organization dedicated to advancing patient care through research, is seeking an experienced Senior Clinical Research Manager to lead their operations in Kansas City, Missouri, US . This vital on-site role involves overseeing multiple clinical research studies, ensuring adherence to protocols, regulatory requirements, and ethical standards. You will manage a team of research coordinators, study nurses, and data managers, providing guidance, training, and performance evaluations. The ideal candidate will possess a strong understanding of clinical trial methodologies, ICH-GCP guidelines, FDA regulations, and various therapeutic areas. Responsibilities include protocol development, budget management, subject recruitment, data integrity, and site operations. We are looking for a highly organized, detail-oriented leader with excellent communication and interpersonal skills, committed to the successful execution of impactful clinical research.

Key Responsibilities:

• Oversee the planning, execution, and completion of multiple clinical research studies.
• Ensure all research activities comply with study protocols, institutional policies, and regulatory requirements (e.g., FDA, ICH-GCP).
• Manage and mentor a team of clinical research professionals, including study coordinators and research nurses.
• Develop and manage study budgets, ensuring financial accountability.
• Oversee subject recruitment, enrollment, and retention strategies.
• Ensure the accuracy, completeness, and integrity of clinical data collected.
• Collaborate with investigators, sponsors, and regulatory agencies.
• Develop and implement standard operating procedures (SOPs) for clinical research activities.
• Conduct regular site visits and audits to ensure quality and compliance.
• Contribute to the development of new research protocols and grant applications.

Required Qualifications:

• Master's degree in Nursing, Pharmacy, Public Health, or a related healthcare field.
• Minimum of 7 years of experience in clinical research, with at least 3 years in a supervisory or management role.
• In-depth knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements (FDA, IRB).
• Proven experience managing complex clinical trials across various therapeutic areas.
• Strong understanding of study design, data management, and statistical analysis principles.
• Excellent leadership, team management, and communication skills.
• Exceptional organizational and problem-solving abilities.
• Proficiency in clinical trial management software and electronic data capture (EDC) systems.
• Relevant certifications (e.g., CCRP, CCRA) are highly desirable.
• Ability to work effectively in a fast-paced, demanding research environment.

This on-site position offers a competitive salary, comprehensive benefits package, and the opportunity to contribute to life-changing medical advancements. Join a dedicated team at the forefront of healthcare innovation.

**Job Description**
Responsible for the daily planning, organizing, directing and controlling of the operations of assigned area, in order to meet the needs of all customers, Faculty and support of Medical Center goals and philosophies. The Manager, Research Operations assumes fiscal responsibility through preparation of unit budgets, serves as liaison with Faculty and other personnel, promotes the maximum growth and development of each employee, supports research, participates in both strategic and tactical planning.
The Manager, Research Operations is accountable to the Department Chair and/or Institute Executive Director and serves as the primary source of information for the department. She/he maintains competency skills including the ability to interact with Faculty and staff within their assigned area, the Medical Center and throughout the Health System. The Manager, Research Operations plans, organizes, manages and controls the daily operations of their area and works closely with departmental leadership, Faculty, Principal Investigators (PIs), staff and students to provide analytical support and project management in fulfilling the established goals and objectives for the department and organization. Strategizes and collaborates with the Director and senior leadership, along with Academic Affairs regarding development and implementation of policies and procedures.
Manages and supervises administrative staff; provides leadership coaching, and opportunities for professional development. The Manager, Research Operations facilitates Human Resource (HR) functions for their area by collaborating with the appropriate HR partners for Faculty and department staff recruitment, visa and immigration assistance, employee relations, compensation, and benefits.
**Primary Duties and Responsibilities**
+ Ensures compliance with state and federal laws, accreditation, professional and regulatory agency standards and licensure requirements. Maintain staff compliance with medical center policies, procedures and protocols.
+ Assumes fiscal responsibility for the department including unit budget preparation, labor and supply cost management, and revenue enhancement.
+ Responsible for tracking and reporting all high-level Capital/Operations projects. Prepares complex or highlevel regular and ad-hoc financial reports for the Department Chair and/or Institute Executive Director. Works closely with leadership to develop processes and tools to monitor research funding and activities for the area.
+ In collaboration with the Department Chair, Institute Executive Director and/or Division Director develops business operations plans for department and for specific programs and services within it.
+ Supervises the research protocols as mandated for research and ensures optimal levels and continuous improvement of quality within their work area. Maintains appropriate quality management and oversight programs.
+ Supervises department employees, including responsibility for determining qualifications, hiring, maintaining and improving competence, assigning work, coaching, training (e.g. orientation, in-service and continuing education), evaluating performance, compensation, discipline and terminating employment.
+ Interact regularly with PIs and staff to assess team needs, provide information and resolve issues.
+ Promote a team atmosphere and manage staff regarding but not limited to the following: Manage the onboarding of new lab staff, Develop job descriptions, Conduct employee annual appraisals, Identify staffing needs, Conduct probationary period meetings with new staff, and Counsel, coach and terminate staff as appropriate.
+ In collaboration with the Institute Executive Director and/or Division Director, develops business and operations plans for department and for specific programs and services within it.
+ Manages the effective utilization of human resources and supplies within the department, including the development of appropriate staffing and management of productivity. Develop staffing plans in response to research and department activity. Recommend space and other resources for needed services. Participate in the selection of outside sources for needed services.
+ Collaborates with other research, department and clinical/support service managers in other areas to help foster cross-functional process improvement, collaborative teamwork, open communication and problem solving to ensure the effective coordination and integration of services within and between units.
+ Works closely with the Office of Research Administration and designated Research Grant Specialist to ensure all grant awards are appropriately managed and maintained for Faculty holding a primary appointment in the area.
+ Responsible for facilitating the Faculty contracting process in coordination with Academic Human Resources.
+ Performs all other duties as assigned.
Department-Specific Responsibilities
**Clinical & Translational Research Center/Science Inst (CTRC/CTSI)**
+ Understands CTSI program, structure, SAC governance, and its relationship to Research Institute and Cedars-Sinai Medical Center. Completed CTSI competency and Orientation Plan, Human Subject Protections (IRB) Education requirement: annual classes, CE requirements met.
+ The Manager works with the Research Subject Advocate (RSA) Medical Director as needed for the oversight of CTRC compliance activities. The Manager is also responsible to oversee the Scientific Advisory Committee meetings to review all new protocol requests.
+ The position also requires substantial knowledge of and experience with grantsmanship (pre- and post-award grants management), grant writing, organization and submission of continuation or competitive grant applications, supporting clinical research infrastructure.
+ Responsible for annual reporting requirements to the NIH-NCATS, based on database compilation of clinical protocol census activity, research manuscript publications, program progress narratives, scientific highlights, investigator's, other support, young investigator awards, Core Lab voucher distribution and use, and all expenditures for patient care expenses and equipment purchases.
+ Responsible for yearly NlH NCATS CTSI continuation budgets and 5-year competitive grant application budgets along with budget justifications and the CSRI yearly supplement budgets for the CTSI and related core programs.
+ Responsible for oversight of various CTSI program educational activities, including the High School Mentorship, Rubenstein Resident Research Award, the Malaniak PostDoctoral Research Award, Core Curriculum training seminars for the CSRI community, and the Clinical Fellows Research Award programs.
**Inflammatory Bowel and Immunobiology Research Inst (IBIRI)**
+ Support the on-boarding of new Research faculty recruits, ensure all systems and support is in place prior to arrival including HR, safety, immigration related matters, labs, relocation planning and execution, research space and equipment, etc.
+ Researches variance for explanation, corrects errors and oversees the appropriate transfers in a timely manner. Oversees and assists in the preparation of the annual capital/operations budget. Works with the Research Grant Specialist to provide budget and staffing information.
Neurosurgery
+ Supports the on-boarding of new Research faculty recruits, ensure all systems and support is in place prior to arrival including HR, safety, immigration related matters, labs, relocation planning and execution, research space and equipment, etc.
+ Researches variance for explanation, corrects errors and oversees the appropriate transfers in a timely manner. Oversees and participates in the preparation of the annual capital/operations budget as well as monthly reconciliation related to research grant management. Works with the Research Grant Specialist to provide budget and staffing information.
**Regenerative Medicine Inst (RMI)**
+ Reconciles tracked expenses from on-line systems and participates in managing spending and budgeting research grant monies.
+ Researches variance for explanation, corrects errors and oversees the appropriate transfers in a timely manner. Oversees and assists in the preparation of the annual capital/operations budget. Works with the Research Grant Specialist to provide budget and staffing information.
Emergency Medicine Research
+ Maintains direct oversight of regulatory/IRB operations from start-up to closeout.
+ Serves as sub/co-investigator on clinical trials, observational research, and biobanking protocols.
+ Responsible for organization, preparation, and submission of investigator-initiated study applications including IND submissions to the FDA.
+ Manages Clinical Coordinating Center (CCC) with academic and industry partners. Implements recruitment strategies and workflows to ensure top enrollment in global clinical trials.
+ Obtains informed consent for clinical trials and research cohorts, per advanced approvals by Executive Director of Cedar-Sinai Geri and Richard Brawerman Nursing Institute.
+ Collaborates with OLAR and EIS to assure compliance with research procedures on hospital units and documentation within the EMR.
+ Participates in monitoring and auditing activities as well as site visits from sponsors, Clinical Research Organizations and FDA.
+ Conceptualizes and builds research databases and case report forms (CRFs) for federally funded and industry-sponsored multi-site protocols.
+ Develops timelines and standard operating procedure manuals for all research projects.
+ Engages in manuscript writing, preparation, and submission. Coordinates with staff to meet the educational goals of unit.
+ Mentors undergraduate research interns. Assists other research teams with nursing duties when asked.
+ Provides direct patient care to research participants including performing phlebotomy and specimen collections, performing ECGSs, initiating and monitoring IV infusions, administering study drugs, performing patient assessments including vital sign measurement, and documenting accordingly, including all adverse events. Triages phone calls from research participants.
+ Guides nursing staff in the provision of nursing care consistent with Nursing Standards of Care/Practice, the Plan for Provision of Nursing Care, The Plan for Provision of Patient Care, CSMC Code of Conduct, the Performance Improvement Plan, the Patient Education Plan and Professional Organization Standards.
**Qualifications**
**REQUIREMENTS**
+ Bachelor's Degree in Business, Administration, Nursing, or equivalent work experience required
+ 5 years of related supervisory or management experience, with increasing responsibility
**Preferred Qualifications:**
+ Master's Degree (MBA or MPH) strongly preferred
+ 2 years of experience in finance or budget oversight. Knowledge of general accounting and financial analysis.
+ Knowledge of GAAP rules helpful
**Req ID** : 12570
**Working Title** : Clinical Research Manager, Research Operations
**Department** : Cancer - SOCCI Clinical Research
**Business Entity** : Cedars-Sinai Medical Center
**Job Category** : Academic / Research
**Job Specialty** : Academic/Research Services
**Overtime Status** : EXEMPT
**Primary Shift** : Day
**Shift Duration** : 8 hour
**Base Pay** : $55.31 - $96.79
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Discovery & Pre-Clinical/Clinical Development
**Job Sub** **Function:**
Clinical Development & Research - Non-MD
**Job Category:**
People Leader
**All Job Posting Locations:**
Irvine, California, United States of America
**Job Description:**
Johnson & Johnson MedTech - Electrophysiology division is currently seeking a **Clinical Research Manager** . The role's preferred location is Irvine, California however we are open to remote candidates within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at  
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at limited supervision, this Clinical Research Manager will provide leadership to a team of Clinical Research Leaders (CRLs) and Clinical Research Specialists (CRSs) and ensure the successful performance and delivery of project deliverables, on time with high quality. The Clinical Research Manager will be responsible for encouraging strong, positive relationships with co-workers across the organization.
**Key** **Duties/Responsibilities**
+ Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring monitoring compliance with timelines and study milestones for JNJ MedTech - Electrophysiology
+ Provide leadership and oversight for monitoring activities of clinical trials, aligning activities with broader study objectives, and providing input on trial design to optimize monitoring efficiency and effectiveness
+ Experience documenting and sharing insights into trial monitoring activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality); external partners e.g. principal investigators and support staff, and internal partners e.g. study team, management and leadership staff
+ Contribute to the oversight of feasibility, selection, set up, conduct and closure of a clinical trial as related to monitoring activities within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
+ Perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits
+ May be involved in the management and oversight of device ordering, tracking, and accountability of investigational products and trial materials
+ May be involved in the team's interface and collaboration with key opinion leaders, site investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel
+ Provide input on clinical data review to prepare data for statistical analyses and publications
+ Lead on-site procedural protocol compliance and data collection to the clinical trial sites
+ Is responsible for delivery of monitoring deliverables for assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)
+ May liaise with regional partners to ensure global standard processes are shared and applied across the organization
+ Plans, tracks and manages assigned monitoring project budgets to ensure adherence to business plans
+ Ensures resources assigned to designated clinical trials to provide quality deliverables while maintaining efficiency
+ Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
+ Should develop a strong understanding of the pipeline, product portfolio and business needs
+ Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed;
+ Responsible for communicating business related issues or opportunities to next management level
+ Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures;
+ Performs other duties assigned as needed
**Qualifications :**
**Required Education & Skills/Experience:**
+ Minimum of a bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 8 years clinical research experience is required
OR
Masters degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 7 years clinical research experience is required
**OR**
PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
+ Previous experience in managing or supervising global clinical trials
+ A minimum of 2 years leadership / management role within Clinical Research including 1-2 years of people management experience is required.
+ Clinical project leadership across multiple studies/ programs is required.
+ Experience working well with cross-functional teams is required.
+ Experience with budget planning, tracking and control is required.
+ Medical Device experience is required.
**Preferred Education & Skills/Experience:**
+ Bachelor's Degree in Life Science, Physical Science, Nursing, or Biological Science is preferred.
+ Relevant industry certifications are preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, .).
+ Clinical/medical background is a plus.
**Other:**
+ This position may require up to 25% travel depending on the phase of the program.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
#PULSE #EP

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Discovery & Pre-Clinical/Clinical Development
**Job Sub** **Function:**
Clinical Development & Research - Non-MD
**Job Category:**
People Leader
**All Job Posting Locations:**
Irvine, California, United States of America
**Job Description:**
Job Description
Johnson & Johnson MedTech, Electrophysiology, is recruiting a **Clinical Research** **Manager.** This role is based in Irvine, CA on a hybrid work schedule onsite 2-3 days a week.
Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at  
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at limited supervision, this Clinical Research Manager will provide leadership to Clinical Research Scientists ensuring the successful performance and delivery of project deliverables, on time with high quality. The Clinical Research Manager with be a part of the Clinical Science & External Research (CSER) Team and be responsible for encouraging strong, positive relationships with co-workers across the organization.
**Key Duties/Responsibilities**
+ Oversees the study program, ensures compliance with procedures, monitors studies based on data need, identifies risks with appropriate escalation
+ Drives prioritization within the research program based on strategic direction
+ Ensures that timelines, risks and publications are tracked, validated and communicated
+ Reviews the program dashboard and tracers, provides inputs as needed and synthesizes study level details into summaries
+ Manages assigned study level execution for pre-market and post-market collaborative studies, including protocol development, cross functional collaboration for approvals, ensuring compliance for data collection, and data review.
+ Represents the program in meetings as needed
+ Provides leadership and oversight for scientific aspects of the program- study design review, literature search quality check, study level scientific accuracy in tracker and reports
+ May be involved in the management and oversight of device ordering, tracking, and accountability of investigational products and trial materials
+ May be involved in the team's interface and collaboration with key opinion leadersand external researchers
+ May liaise with regional partners to ensure global standard processes are shared and applied across the organization
+ Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
+ Has a strong understanding of the pipeline, product portfolio and strategic business needs
+ Manages work independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed
+ Responsible for communicating business related issues or opportunities to next management level
+ Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
+ Performs other duties assigned as needed
**Qualifications**
**Required Education & Skills/Experience:**
+ Minimum of a bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 8 years clinical research experience is required
OR
+ Masters degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 7 years clinical research experience is required
OR
+ PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
+ Previous experience in managing or supervising global clinical trials
+ A minimum of 2 years leadership / management role within Clinical Research including 1-2 years of people management experience is required.
+ Clinical project leadership across multiple studies/ programs is required.
+ Experience working well with cross-functional teams is required.
+ Experience with budget planning, tracking and control is required.
+ Medical Device experience is required.
+ Sound knowledge ofICH-GCP, Clinical trial procedures
**Preferred Education & Skills/Experience:**
+ Relevant industry certifications are preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, .).
+ Clinical/medical background is a plus.
**Other:**
+ This position may require up to 35% travel depending on the phase of the program.
+ Primary location for this position is Irvine, CA. At management discretion, the position may be performed remotely.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Discovery & Pre-Clinical/Clinical Development
**Job Sub** **Function:**
Clinical Development & Research - Non-MD
**Job Category:**
People Leader
**All Job Posting Locations:**
Irvine, California, United States of America
**Job Description:**
Johnson & Johnson MedTech - Electrophysiology division is currently seeking a **Clinical Research Manager** . The role's preferred location is Irvine, California however we are open to remote candidates within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at  
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at Responsibilities:**
This Clinical Research Manager will be responsible for clinical trial management within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
+ Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones for JnJ MedTech Electrophysiology;
+ Has oversight of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
+ Manages and oversees ordering, tracking, and accountability of investigational products and trial materials;
+ Ensures applicable trial registration (e.g. ) from study initiation through posting of results and support publications as needed;
+ Is responsible for team's interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel;
+ Is responsible for clinical data review to prepare data for statistical analyses and publications;
+ May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
+ In EMEA, responsible for Regulatory Affairs related tasks associated with clinical trials and evidence generation. (See ANNEX I - Regulatory Affairs Duties and Responsibilities);
+ Contribute to the development and delivery of appropriate Global EGS (Evidence Generation Strategies)/ EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), ensuring cross-functional alignment;
+ Ensures input and strong alignment from key regional Clinical R&D leads and other strategically important countries/ regions in the development of the EGS/ EDS;
+ Leads in study design to develop appropriate clinical trials to meet the clinical evidence needs;
+ May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
+ Leads in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, Abstracts, Manuscripts, Clinical Evaluation Reports, etc.;
+ Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
+ Plans, tracks and manages assigned project budgets to ensure adherence to business plans;
+ Contributes in clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;
+ Serves as the clinical representative on a New Product Development team;
+ Is responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;
+ Conducts review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;
+ Is responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition;
+ Manages and mentors resources assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency;
+ Is responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development;
+ Is responsible for communicating business related issues or opportunities to next management level. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
+ Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
+ Should develop a strong understanding of the pipeline, product portfolio and business needs;
+ Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed.
+ May perform other duties assigned as needed;
**Qualifications**
**Required Education & Skills/Experience:**
+ Minimum of a bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 8 years clinical research experience is required
OR
+ Masters degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 7 years clinical research experience is required
OR
+ PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
+ Previous experience in managing or supervising global clinical trials
+ A minimum of 2 years leadership / management role within Clinical Research including 1-2 years of people management experience is required.
+ Clinical project leadership across multiple studies/ programs is required.
+ Experience working well with cross-functional teams is required.
+ Experience with budget planning, tracking and control is required.
+ Medical Device experience is required.
+ Sound knowledge ofICH-GCP, Clinical trial procedures
+ Up to 25% travel is required for this role.
**Preferred Education & Skills/Experience:**
+ Relevant industry certifications are preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, .).
+ Clinical/medical background is a plus.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
#PULSE #EP