2,308 Clinical Trial Manager jobs in the United States

• Support all clinical research activities to ensure effective management of clinical studies.
• Maintain and track clinical study data, assist in investigator qualification and selection, monitor patient recruitment, and oversee study progress.
• Manage clinical research organizations (CRO) involved with the study.
• Oversee site startup/activation processes, including preparing study documents such as protocols, CRFs/eCRFs, informed consent forms, and clinical monitoring plans.
• Organize IRB/EC submissions and ensure regulatory compliance for successful outcomes
• Amend clinical study documents as needed and assist clinical sites with institutional review board submissions.
• Perform on-site and remote site qualification, initiation, interim monitoring, and close-out visits.
• Conduct clinical study monitoring to ensure compliance with regulations and protocols, ensuring data accuracy.
• Verify source data of clinical study data in EDC systems or case report forms at sites.
• Serve as the main liaison for participating clinical trial sites, focusing on data entry, query resolution, investigational device tracking, and accountability.
• Drive safety event reviews and develop necessary narratives and reports. Manage CEC and DSMB if applicable
• Manage trial master files, maintain study documentation, and clinical trial management systems.
• Track and process site payments, develop tracking tools as necessary, and assist in study financial tracking.
• Develop pre-study questionnaires, study designs, and assist in physician/site selection.

• Previous experience in managing and implementing medical device trials.
• In-depth knowledge of clinical and outcomes research study design.
• Advanced knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR Part 11, 50, 54, 812, and other relevant regulations.
• Familiarity with ICH/GCP guidelines and other applicable regulations.
• Preferred clinical research/clinical trial management certification/education.
• Prior clinical setting experience preferred.
• Strong ability to interact with physicians and professionals inside and outside the company.
• Experience in protocol and ICF development, writing clinical sections for regulatory submissions.
• Experience negotiating clinical research contracts and budgets.
• Experience managing a clinical events committee and data safety monitoring board.
• Ability to work effectively on cross-functional teams and manage multiple projects and priorities.
• Excellent communication, presentation, and organizational skills with high attention to detail.
• Ability to learn quickly and self-educate on various surgical specialties applicable to clinical projects.
• Ability to manage CROs and provide relevant study updates to management.
• Strong work ethic to meet tight timelines or manage multiple projects with a problem-solving mindset.
• Proficiency in Microsoft Office Suite and PDF applications.
• Experience with electronic data capture (EDC) systems required.
• Required experience in the medical device industry.

• A minimum of 8 years of medical device clinical trials experience
• Microsoft Office proficiency
• Ability to work onsite in Santa Cruz as needed
• Knowledge of medical terminology.
• Knowledge of statistics, statistical methods, and experiment design is highly preferred.

• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients.
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family , as well as flex time off.
• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you'd like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!

Key Responsibilities:

• Lead and manage all operational aspects of global clinical trials from study start-up through close-out
• Oversee study timelines, deliverables, and budgets to ensure milestones are met
• Coordinate with cross-functional teams, external vendors, and CROs to ensure high-quality study conduct
• Oversee site activation, clinical monitoring, data integrity, and adherence to protocol
• Conduct study-level risk assessments and ensure inspection readiness
• Manage safety and pharmacovigilance activities in collaboration with internal and external teams
• Lead internal and external study meetings; provide training to relevant stakeholders
• Contribute to the development of study-related documents and clinical study reports
• Perform other duties as needed to support successful trial execution

Qualifications:

• Bachelors degree in life sciences or a related field (advanced degree preferred)
• Minimum of 8 years of clinical trial management experience, particularly in Phase 2/3 respiratory trials
• Demonstrated success in leading global trials and working with cross-functional and vendor teams
• Deep understanding of GCP, ICH guidelines, and global regulatory requirements
• Specific therapeutic experience in respiratory diseases, especially COPD , strongly preferred
• Strong project management, problem-solving, and communication skills
• Proficiency in using clinical trial systems (e.g., eTMF, EDC), Microsoft Office, and Excel
• Must reside in the Raleigh-Durham-Chapel Hill area , with availability to work on-site as needed for meetings and collaboration

• Deliver operational excellence.
• Support coordination of clinical operations required to initiate, execute, and complete clinical trials to drive on-time delivery of milestones.
• Support Calibr Clinical team functions.
• Develop and maintain active clinical trial documents including protocols, informed consent forms, case report forms, operational plans.
• Assist in set-up and maintenance of clinical trial documentation including preparation for audits, final reconciliation, and archives.
• Conduct data review and assist in identification of data discrepancies while engaging vendors, CROs and site personnel in resolution as needed.
• Monitor and/or co-monitor clinical trials sites, as necessary.
• Support audit activities including inspection readiness.
• Track investigational supplies, specimens, imaging.
• Support vendor selection and CRO activities.
• Collaborate with internal team members, Contract Research Organizations, and vendors on all deliverables.
• Perform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines.
• Contribute to process improvement initiatives, departmental projects, development, and maintenance of Standard Operating Procedures (SOPs).

• Minimum BA/BS or equivalent or relevant and qualifying training and experience.
• 1+ years' experience in clinical trial support, operations or management experience at a biotechnology or pharmaceutical company or CRO; or other relevant research or project management experience.
• Ability and willingness for minimal travel (approximately 3 days every other month).
• Excellent leadership, communication, and organizational skills.
• Able to take initiative and communicate cross-functional needs and expectations.
• Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems.
• Strong communication and inter-personal skills.
• Highly responsive and proactive.
• Knowledge of CFR and GCP/ICH requirements.
• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF).
• Strong problem resolution and conflict management skills.
• Attention to detail.
• Strongly Preferred: Oncology clinical trial experience.

• Employer Contributed Retirement Plan - Depending on eligibility, employees receive an employer contributed retirement plan (no employee contribution required) and the option to contribute to a 403(b) (which is similar to a 401(k) using your own pre or post-tax dollars)
• Full Suite of Health and Welfare plans including three medical plan options (including an HSA available option), dental, vision, life insurance, disability, EAP and more
• Access to Flexible Spending Accounts (Medical/Dependent Care)
• Competitive vacation and sick leave policies
• Free, on-site parking

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

• Oversee the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities, ensuring that all aspects of the trial are conducted efficiently and effectively
• Collaborate with principal investigators, research subjects, client teams, investigators, and clinic operations teams to facilitate communication and coordination, ensuring that all parties are aligned and informed throughout the trial process
• Plan logistics and resource usage for clinical trials, including the allocation of staff, equipment, and materials, to ensure that trials are conducted smoothly and without delays
• Track study progress in alignment with project milestones, client deliverables, and budget, using project management tools and techniques to monitor and report on the status of the trial
• Ensure compliance with applicable regulations globally and by region, including adherence to Good Clinical Practice (GCP) guidelines, ethical standards, and regulatory requirements, to maintain the integrity and quality of the trial
• Manage a team of individual contributors and supervisors, providing strategic vision and tactical direction, setting goals and objectives, and monitoring performance to ensure that the team operates effectively and achieves its targets
• Deliver operational results that have direct impact on immediate or short-term department outcomes, using data-driven decision-making and problem-solving skills to address challenges and optimize trial performance
• Provide in-depth knowledge and skills within the scientific/technology or professional discipline, understanding the impact of work on related areas, and leveraging expertise to contribute to the advancement of the organization's research objectives
• Utilize practical knowledge in managing the execution of processes, projects, and tactics within the team, ensuring that all activities are conducted in accordance with established protocols and procedures

• Bachelor's degree in a relevant scientific or healthcare field; advanced degree preferred
• Minimum of 5 years of experience in clinical trial management, with a focus on Phase 1 studies
• Proven track record of managing clinical trials and delivering successful outcomes
• Strong understanding of global and regional regulations related to clinical research
• Excellent organizational, planning, and resource management skills
• Ability to lead and manage a team, providing strategic vision and tactical direction

• Certified Clinical Research Professional (CCRP) or equivalent certification preferred
• Project Management Professional (PMP) certification is a plus

• In-depth knowledge of clinical trial processes and regulations
• Strong leadership and team management skills
• Excellent communication and collaboration abilities
• Proficiency in project management and resource planning
• Ability to analyze and interpret complex data
• Strong problem-solving and decision-making skills

Description ABOUT US Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Scripps Research is ranked one of the most influential institutions in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading edge scientists. Leveraging the unique scientific environment of Scripps Research, impacting translational sciences, Calibr-Skaggs has created a portfolio of drug candidates, and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while re-investing in further innovative research. We expand basic knowledge in the biosciences and use these fundamental advancements to develop profound innovations that improve wellbeing. Calibr-Skaggs' drug development portfolio spans a broad range of human diseases, including cancer, autoimmunity and inflammatory diseases, metabolic and cardiovascular diseases, infectious and neglected diseases, as well as age-related and degenerative diseases. If you have a passion for making a difference, this could be your opportunity to join our transformative team. Position Summary The Associate Clinical Trial Manager supports the internal Calibr Clinical team, clinical site teams and CRO/vendor partners in execution of early-phase clinical trials across multiple therapeutic areas. Focus on immuno-oncology and a wide range of programs covering neurodegeneration, metabolic disorders, autoimmunity, and others. Assists in the execution of complex clinical programs, participates in the design and planning of clinical studies, and delivers successful operational outcomes across multiple Phase 1 and 2 clinical trials. The Clinical Trial Manager will apply their excellent operational capabilities as the main driver for project delivery within timelines and budget in accordance with the protocol while ensuring compliance with ethical and regulatory requirements. Responsibilities and Duties Deliver operational excellence. Support coordination of clinical operations required to initiate, execute, and complete clinical trials to drive on-time delivery of milestones. Support Calibr Clinical team functions. Develop and maintain active clinical trial documents including protocols, informed consent forms, case report forms, operational plans. Assist in set-up and maintenance of clinical trial documentation including preparation for audits, final reconciliation, and archives. Conduct data review and assist in identification of data discrepancies while engaging vendors, CROs and site personnel in resolution as needed. Monitor and/or co-monitor clinical trials sites, as necessary. Support audit activities including inspection readiness. Track investigational supplies, specimens, imaging. Support vendor selection and CRO activities. Collaborate with internal team members, Contract Research Organizations, and vendors on all deliverables. Perform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines. Contribute to process improvement initiatives, departmental projects, development, and maintenance of Standard Operating Procedures (SOPs). Position Requirements Minimum BA/BS or equivalent or relevant and qualifying training and experience. 1+ years' experience in clinical trial support, operations or management experience at a biotechnology or pharmaceutical company or CRO; or other relevant research or project management experience. Ability and willingness for minimal travel (approximately 3 days every other month). Excellent leadership, communication, and organizational skills. Able to take initiative and communicate cross-functional needs and expectations. Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems. Strong communication and inter-personal skills. Highly responsive and proactive. Knowledge of CFR and GCP/ICH requirements. Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF). Strong problem resolution and conflict management skills. Attention to detail. Strongly Preferred: Oncology clinical trial experience. PHYSICAL REQUIREMENTS May include stationary position for an extended period of time, traverse campus/facility as needed, operate machinery such as computer, phone, copy machine, exposure to cold or hot temperatures. COMPENSATION The expected hiring range for this position is $109,000 to $115,000, commensurate with experience. Consideration will be given to experience that exceeds the listed requirements. COMPREHENSIVE BENEFITS INCLUDE Employer Contributed Retirement Plan - Depending on eligibility, employees receive an employer contributed retirement plan (no employee contribution required) and the option to contribute to a 403(b) (which is similar to a 401(k) using your own pre or post-tax dollars) Full Suite of Health and Welfare plans including three medical plan options (including an HSA available option), dental, vision, life insurance, disability, EAP and more Access to Flexible Spending Accounts (Medical/Dependent Care) Competitive vacation and sick leave policies Free, on-site parking The above statements describe the level of work performed and expected in general terms. The statements are not intended to list all the responsibilities, duties and/or skills required of employees so classified, and the content herein is subject to change due to the business needs of Scripps Research, with or without notice. Furthermore, nothing in this job description shall be interpreted to be in conflict with or to eliminate or modify in any way the employment-at-will status of Scripps Research staff. EEO Statement: The Scripps Research Institute is an Equal Opportunity Employer. We promote diversity of thought, culture, and background in the fields of science. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic or status. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr

ABOUT US Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Scripps Research is ranked one of the most influential institutions in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading edge scientists. Leveraging the unique scientific environment of Scripps Research, impacting translational sciences, Calibr-Skaggs has created a portfolio of drug candidates, and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while re-investing in further innovative research. We expand basic knowledge in the biosciences and use these fundamental advancements to develop profound innovations that improve wellbeing. Calibr-Skaggs’ drug development portfolio spans a broad range of human diseases, including cancer, autoimmunity and inflammatory diseases, metabolic and cardiovascular diseases, infectious and neglected diseases, as well as age-related and degenerative diseases. If you have a passion for making a difference, this could be your opportunity to join our transformative team. Position Summary The Associate Clinical Trial Manager supports the internal Calibr Clinical team, clinical site teams and CRO/vendor partners in execution of early-phase clinical trials across multiple therapeutic areas. Focus on immuno-oncology and a wide range of programs covering neurodegeneration, metabolic disorders, autoimmunity, and others. Assists in the execution of complex clinical programs, participates in the design and planning of clinical studies, and delivers successful operational outcomes across multiple Phase 1 and 2 clinical trials. The Clinical Trial Manager will apply their excellent operational capabilities as the main driver for project delivery within timelines and budget in accordance with the protocol while ensuring compliance with ethical and regulatory requirements. Responsibilities and Duties Deliver operational excellence. Support coordination of clinical operations required to initiate, execute, and complete clinical trials to drive on-time delivery of milestones. Support Calibr Clinical team functions. Develop and maintain active clinical trial documents including protocols, informed consent forms, case report forms, operational plans. Assist in set-up and maintenance of clinical trial documentation including preparation for audits, final reconciliation, and archives. Conduct data review and assist in identification of data discrepancies while engaging vendors, CROs and site personnel in resolution as needed. Monitor and/or co-monitor clinical trials sites, as necessary. Support audit activities including inspection readiness. Track investigational supplies, specimens, imaging. Support vendor selection and CRO activities. Collaborate with internal team members, Contract Research Organizations, and vendors on all deliverables. Perform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines. Contribute to process improvement initiatives, departmental projects, development, and maintenance of Standard Operating Procedures (SOPs). Position Requirements Minimum BA/BS or equivalent or relevant and qualifying training and experience. 1+ years’ experience in clinical trial support, operations or management experience at a biotechnology or pharmaceutical company or CRO; or other relevant research or project management experience. Ability and willingness for minimal travel (approximately 3 days every other month). Excellent leadership, communication, and organizational skills. Able to take initiative and communicate cross-functional needs and expectations. Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems. Strong communication and inter-personal skills. Highly responsive and proactive. Knowledge of CFR and GCP/ICH requirements. Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF). Strong problem resolution and conflict management skills. Strongly Preferred: Oncology clinical trial experience. PHYSICAL REQUIREMENTS May include stationary position for an extended period of time, traverse campus/facility as needed, operate machinery such as computer, phone, copy machine, exposure to cold or hot temperatures. COMPENSATION The expected hiring range for this position is $109,000 to $115,000, commensurate with experience. Consideration will be given to experience that exceeds the listed requirements. COMPREHENSIVE BENEFITS INCLUDE Employer Contributed Retirement Plan – Depending on eligibility, employees receive an employer contributed retirement plan (no employee contribution required) and the option to contribute to a 403(b) (which is similar to a 401(k) using your own pre or post-tax dollars) Full Suite of Health and Welfare plans including three medical plan options (including an HSA available option), dental, vision, life insurance, disability, EAP and more Access to Flexible Spending Accounts (Medical/Dependent Care) Competitive vacation and sick leave policies Free, on-site parking The above statements describe the level of work performed and expected in general terms. The statements are not intended to list all the responsibilities, duties and/or skills required of employees so classified, and the content herein is subject to change due to the business needs of Scripps Research, with or without notice. Furthermore, nothing in this job description shall be interpreted to be in conflict with or to eliminate or modify in any way the employment-at-will status of Scripps Research staff. EEO Statement: The Scripps Research Institute is an Equal Opportunity Employer. We promote diversity of thought, culture, and background in the fields of science. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic or status. #J-18808-Ljbffr