8 Clinical Development Director jobs in Beaverton
Medical Director, Clinical Development
Posted 4 days ago
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Job Description
Absci is a data-first AI drug creation company designing differentiated therapeutics using generative AI. Our Integrated Drug Creation platform powers cutting-edge de novo AI models and AI lead optimization models aimed at designing better biologics against difficult-to-drug targets.
Absci is a global company with a state-of-the-art lab and headquarters in Vancouver, WA, AI Research Lab in New York City, AI Computational Center in Serbia, and Drug Creation innovation center in Switzerland. absci.com/joinus
Medical Director, Clinical Development
Flexible ( Remote, Hybrid, or Onsite in Vancouver, WA)
Absci is seeking a highly skilled, entrepreneurial physician-scientist to serve as Medical Director for Clinical Development. In this pivotal role, you will act as the clinical lead for multiple programs, steering strategy and execution from early development through pivotal trials across immunology and dermatology - and, when priorities shift, additional therapeutic areas. You will shape protocol concepts, build influential KOL (Key Opinion Leader) networks, and provide expert medical oversight that accelerates our drugs to patients worldwide.
Responsibilities:
Clinical Development Leadership
- Co-develop and co-own the clinical development strategy and lifecycle planning for assigned programs from a medical perspective.
- Adjust plans rapidly in response to evolving corporate priorities, scientific insights, and market conditions.
- Lead authoring of study concepts, protocols, investigator brochures, and key clinical sections of regulatory dossiers.
- Translate high-level product concepts into efficient, innovative clinical trial designs that reduce time to market in collaboration with Translational Research.
- Identify, recruit, and cultivate a global network of key opinion leaders aligned with program strategy.
- Partner with investigators, patient-advocacy groups, and advisory boards to optimize trial feasibility and relevance.
- Analyze emerging clinical data, provide medical review of tables/listings/figures, and drive data-driven decisions.
- Serve as Safety Officer as needed, ensuring participant safety and scientific integrity throughout execution.
- Interface with FDA, EMA, and other health authorities; craft and defend clinical development arguments.
- Collaborate closely with Clinical Operations, Translational Research, CMC, Regulatory and other functions to assure seamless program execution.
- Proactively surface clinical, operational, and regulatory risks; design and execute mitigation plans.
- Champion a culture of quality, compliance, and continuous improvement.
- Medical Degree (MD or equivalent) with residency; subspecialty training in immunology, dermatology, or related field preferred.
- 5+ years' industry experience in biotechnology or pharmaceuticals, with a record of leading global clinical programs and authoring successful protocols.
- Demonstrated success accelerating therapies from early-stage to late development, including direct engagement with regulators.
- Expertise in clinical trial design, biostatistics fundamentals, and data interpretation.
- Experience with monoclonal antibodies, cytokine/immune-modulating therapies, or other biologics.
- Prior IND submission experience.
- Familiarity with AI-enabled drug discovery or data-rich translational approaches.
- We are one team with one finish line: As Medical Director, you will need to communicate complex scientific ideas with clarity and inspire diverse teams (We embrace our differences)
- We deliver Results : By being an agile problem-solver, you will anticipate challenges and be prepared to pivot quickly.
- We do the right thing: Building trust with key opinion leaders (KOLs) and regulators by becoming an externally facing ambassador
- Innovate because lives depend on it: As a patient-focused clinician, you will transform cutting-edge science into life-changing medicines.
The salary range is $320,000 to $360,000 per year. Competitive equity package applies. Pay and level offered may vary depending on job-related knowledge, skills, and experience. In addition to equity, compensation packages include a wide range of medical, dental, and vision benefits, as well as the opportunity to participate in our employee stock purchase plan.
Absci offers highly competitive salaries and benefits, including medical, dental, vision insurance, unlimited vacation, parental leave, breakfast and lunch for onsite employees, employee assistance program, voluntary life and disability insurance, annual bonus potential, and 401(k) with a generous company match. Legal authorization to work in the United States is required.
We seek candidates who will dive into our creative company culture that's collaborative, multidisciplinary, and committed to a big vision for positive impact. We are defying conventions and innovating without boundaries. We are disrupting an industry with bold ideas and passionate pursuit of new possibilities. We are looking for original thinkers, creative scientists, and data-devoted gurus. Successful candidates will be excited to work in a dynamic environment and contribute as a key member of a project team. If this sounds good to you, we invite you to join us in our quest to redefine possible.
Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Absci will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Absci offers a dog-friendly work environment - bring your pup along for the ride.
Executive Medical Director, Clinical Development
Posted 4 days ago
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Job Description
Executive Medical Director, Clinical Development
About the Company
Innovative biopharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
1994
Employees
51-200
Categories
- Manufacturing
- Pharmaceuticals
- Medicine
- Chemical Products
- Biotechnology
About the Role
The Company is in search of a Vice President / Executive Medical Director to spearhead the clinical development of its neuromuscular asset. The successful candidate will be the primary clinical development leader, engaging in both internal and external interactions with key stakeholders. This role demands a deep understanding of the science behind the pipeline, excellent leadership skills, and a commitment to the development of new treatments for patients. Responsibilities include serving as the lead physician in all clinical development activities, collaborating with cross-functional teams to create and revise clinical development plans, and leading the design of clinical protocols. The role also involves overseeing the medical monitor, ensuring the continuous evaluation of the drug's safety profile, and participating in interactions with global health authorities. Applicants must have an MD or DO, with board certification/eligibility in neuromuscular and/or rare disease highly desired. A minimum of 7 years of experience in the pharmaceutical or biotech industry, including leading late-stage clinical trials, is required. The ideal candidate will have a proven track record in global clinical research, interaction with health authorities, and successful experience in the end-of-phase 2 and/or NDA/BLA processes. The role calls for an individual with a strong background in clinical trial design, methodology, and statistical concepts, as well as a history of success in leading cross-functional product teams. Outstanding leadership, problem-solving, organizational, and communication skills are essential, as is the ability to travel and work in a highly collaborative, multidisciplinary team setting.
Hiring Manager Title
CMO
Travel Percent
20%
Functions
- Medical Care/Hospital Administration
- Non-Profit Management
Senior Executive Medical Director, Clinical Development
Posted today
Job Viewed
Job Description
Senior Executive Medical Director, Clinical Development
About the Company
Join an innovative biopharmaceutical company dedicated to transforming the future of medicine.
Industry
Pharmaceuticals
Type
Public Company
Founded
1994
Employees
51-200
Categories
- Manufacturing
- Pharmaceuticals
- Medicine
- Chemical Products
- Biotechnology
About the Role
We are seeking a dynamic and experienced Senior Executive Medical Director to lead the clinical development of our cutting-edge neuromuscular asset. This pivotal role will have you at the forefront of clinical innovation, engaging with both internal teams and external stakeholders to drive our mission of delivering new treatments to patients. As the primary clinical development leader, you will oversee all clinical development activities, ensuring alignment with our strategic vision.
Your responsibilities will include:
- Serving as the lead physician and driving all aspects of clinical development.
- Collaborating closely with cross-functional teams to create, implement, and revise comprehensive clinical development plans.
- Leading the design of innovative clinical protocols.
- Overseeing the medical monitor to maintain a continuous evaluation of the drug's safety profile.
- Engaging with global health authorities to advocate for our clinical programs.
To be successful in this role, you should possess an MD or DO, alongside board certification or eligibility in neuromuscular conditions or rare diseases. A minimum of 7 years of relevant experience within the pharmaceutical or biotech industry is essential, particularly in leading late-stage clinical trials. You will have a track record of excellence in global clinical research, successful interactions with health authorities, and experience navigating the end-of-phase 2 and/or NDA/BLA processes.
The ideal candidate will demonstrate robust clinical trial design expertise, a clear understanding of methodology, and statistical concepts, with a history of effectively leading cross-functional teams. Exceptional leadership, problem-solving, organizational, and communication skills are crucial, as well as the willingness to travel and work in a collaborative, multidisciplinary environment.
Hiring Manager Title
CMO
Travel Percent
20%
Functions
- Medical Care/Hospital Administration
- Non-Profit Management
Senior Director, Global Clinical Development CNS
Posted 7 days ago
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Job Description
Position Summary
The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives.
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and/or Global filings.
Key Job Responsibilities
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Conceives, implements, and analyzes drug development programs, including:
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Understanding pharmacology of drugs and unmet medical needs.
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Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy.
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Working with experts and consultants in the field to refine a clinical development strategy.
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Designing clinical trials for the purpose of meeting specific objectives.
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Anticipating and addressing future commercial and clinical development needs, based on the clinicalcharacter of the compound.
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Implements clinical development programs, including:
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Co-authoring global clinical development plans with all practical elements.
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Leading and motivating the clinical development team to operationalize the clinical develop strategy,i.e., clinical trials management.
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Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects.
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Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality.
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Developing and leading formal presentations of results to the medical community, in written, verbal, andvisual formats.
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Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts.
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Partners with biostatistics, medical writers, and external consultants to understand and present the results ofclinical development programs.
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Partners with internal decision makers to evaluate critical decision points.
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Acts as a signatory for the medical monitoring team.
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Contributes to corporate initiatives by participating in continuous process improvement to meet companyobjectives as well as evaluates in-licensing opportunities and/or additional life cycle management opportunities.
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Participates in NDA development, submission and defense.
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Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards.
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Mentors junior team members.
Knowledge, Skills, Competencies, Education, and Experience
Required:
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A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. Board certification in Psychiatry and Neurology is highly desired. Minimum of five years of clinical research experience (post Academia).
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Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
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An advanced understanding of clinical medicine and science.
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Advanced understanding of drug development principles and clinical trial implementation and management.
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Complete understanding of the global regulatory requirements.
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Working knowledge of marketing and commercialization.
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Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
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Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
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Demonstrated experience in leading a successful regulatory filing.
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Ability to work across different therapeutic areas and different stages of clinical development.
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Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
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Strong communication and presentation skills.
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Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
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Knows how/when to apply organizational policy or procedures to a variety of situations.
Physical Demands and Work Environment
Travel (approximately 30 % )
See document Physical Demands and Work Environment for further requirements.
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
Company benefits : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; .
Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Clinical Research Coordinator
Posted today
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Job Description
Responsibilities:
- Coordinate the day-to-day operations of multiple clinical research studies under the guidance of Principal Investigators.
- Recruit, screen, and enroll eligible participants into studies, ensuring adherence to inclusion/exclusion criteria.
- Obtain informed consent from participants, ensuring they fully understand the study procedures and risks.
- Collect, manage, and organize study-related data accurately and efficiently, maintaining case report forms (CRFs) and electronic data capture (EDC) systems.
- Perform study-related procedures as delegated by the PI, such as vital signs, blood draws, and ECGs.
- Process, store, and ship biological samples according to study protocols.
- Monitor study progress, track participant adherence, and manage study timelines.
- Maintain comprehensive and accurate study documentation, including regulatory binders and essential documents.
- Ensure compliance with all applicable regulations, including IRB policies, FDA regulations, and GCP guidelines.
- Serve as a liaison between participants, investigators, sponsors, and regulatory agencies.
- Assist with study close-out activities and archival of study documents.
- Bachelor's degree in a health-related science, nursing, or a relevant field.
- Minimum of 4-5 years of experience as a Clinical Research Coordinator.
- Current RN or LPN license, or Certified Clinical Research Professional (CCRC) or Certified Clinical Research Associate (CCRA) designation is highly preferred.
- Thorough understanding of Good Clinical Practice (GCP), FDA regulations, and IRB procedures.
- Experience with electronic data capture (EDC) systems and clinical trial management software.
- Excellent organizational, time management, and attention-to-detail skills.
- Strong interpersonal and communication skills, with the ability to interact effectively with participants, staff, and sponsors.
- Ability to work independently and as part of a collaborative team.
- Proficiency in medical terminology and clinical procedures.
- Experience in community-based research or a specific therapeutic area is a plus.
Vice President, Clinical Research Endocrinology
Posted today
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Job Description
Vice President, Clinical Research Endocrinology
About the Company
Fast-growing biopharmaceutical company
Industry
Biotechnology
Type
Public Company
Founded
2008
Employees
201-500
Categories
- Biotechnology
- Health Care
- Pharmaceutical
- Therapeutics
- Pharmaceuticals
- Medical Conditions
- Medical Care
- Academic Research
- Advocacy
- Business Partnerships
- Investing
- Medicine
- Manufacturing
- Chemical Products
- Healthcare
Specialties
- drug discovery
- endocrinology
- raredisease
- and biotech
About the Role
The Company is in search of a Vice President for Clinical Research in Endocrinology. The successful candidate will play a pivotal role in the design and implementation of clinical development strategies for the company's endocrinology drug portfolio. This includes leading the creation of innovative trial designs, contributing to clinical strategies, and serving as a clinical research expert in the development of target product profiles. The role also involves overseeing the creation and implementation of clinical development plans, leading medical monitoring of clinical trials, and developing strong external relationships with investigators and patient advocacy groups. The Vice President will be responsible for building and leading a strong team, managing departmental budgets, and ensuring that all activities are in line with regulatory requirements and corporate goals. Candidates for this position must have an MD degree with a minimum of 13 years of clinical research experience in a biopharmaceutical setting, including at least 12 years in a supervisory or leadership role. Board certification in internal medicine or a related specialty is required, along with a broad understanding of internal medicine and clinical pharmacology. The ideal candidate will have a proven track record of successful interactions with regulatory agencies, experience in translational medicine across all clinical trial phases, and a strong knowledge of GCP, ICH guidelines, and regulatory requirements. Excellent leadership, communication, and presentation skills are essential, as is the ability to work both independently and collaboratively in a fast-paced, dynamic environment. The role demands a strategic thinker with the ability to inspire and earn the respect of colleagues and stakeholders, and a commitment to the highest standards of ethics and integrity in the pursuit of developing life-changing therapies for patients.
Hiring Manager Title
Senior Vice President
Travel Percent
20%
Functions
- Medical Care/Hospital Administration
Clinical Research Project Manager, Consultant
Posted today
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Job Description
Clinical Research Project Manager, Consultant Clinical Research Project Manager, Consultant 3 days ago Be among the first 25 applicants This range is provided by Jobot Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $80.00/hr - $0.00/hr Want to learn more about this role and Jobot Consulting? Click our Jobot Consulting logo and follow our LinkedIn page! Job details 12+ Month Remote Consulting Project Management within Clinical Research for Healthcare IT. Join a proven EPMO at a major University driven Healthcare System. PMP preferred and consulting experience preferred as a PM. This Jobot Consulting Job is hosted by Brett Walker Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume. Salary 80 - 90 per hour A Bit About Us A leading university healthcare EPMO looking to add a proven Clinical Research PM. Apply today to learn more about this long term consulting PM project! Qualified candidates preferred to have PMP, extensive experience within University driven healthcare system or major EHR healthcare system, and oversee complex health data innovation and digital transformation initiatives, collaborating with clinicians, researchers, technical teams, and executive stakeholders to deliver impactful technology solutions that improve patient care and operational outcomes. Why join us? Initial 12 month remote Project Management consulting project. W2 or C2C options to consider. Top tier W2 benefits Dedicated consulting concierge team in place to support weekly timesheets and support through out contract/ Job Details Summary We are seeking an experienced Health IT Project Manager with strong skills in eliciting and documenting business and technical requirements, conducting thorough project analysis, and driving alignment across diverse stakeholder groups. The ideal candidate will have a solid foundation in project management practices within healthcare environments, with a bonus for hands-on experience managing technical projects involving AWS services, machine learning, or predictive analytics. This role will oversee complex health data innovation and digital transformation initiatives, collaborating with clinicians, researchers, technical teams, and executive stakeholders to deliver impactful technology solutions that improve patient care and operational outcomes. Required Knowledge And Experience Lead end-to-end project management for IT initiatives in a healthcare IT setting. Facilitate discovery sessions and stakeholder interviews to elicit and document clear, actionable requirements. Perform gap analysis, impact analysis, and translate business needs into functional specifications. Develop project charters, workplans, status reports, and other PMO artifacts. Manage scope, timelines, risks, and resources across matrixed teams. Coordinate with vendors and internal IT to drive timely implementation. Communicate effectively with executive leadership, providing transparent updates and recommendations. Preferred Qualifications Understanding of clinical trials research and associated processes Research budget management experience Experience with clinical data research projects and/or working in an academic medical environment. Familiarity with interfacing HL7 Clinical Document. Architecture (CDA) and/or Fast Healthcare Interoperability Resources (FHIR) PMP or similar certification. Experience with ServiceNow or enterprise project management systems. Familiarity with HIPAA, IRB, and healthcare data privacy standards. Prior project management work with AWS cloud services, machine learning, or predictive analytics platforms is highly desirable. Key Responsibilities Under the direction of the Portfolio Manager the successful candidate will Participate in both strategic planning and tactical execution of clinical research data projects in analysis and implementation; facilitate communications between project partners, clinical researchers and data scientists as they relate to supporting research data acquisition and utilization issues and provide oversight and direction to project team members. Provides program support for BioData Catalyst by leading project management planning, execution, reporting, and close out activities as necessary to ensure the program meets approved program strategies, milestones, and deliverables Provides coordination, management, and oversight of project management activities for the Health Data Informatics and Research team in a matrixed, cross-functional environment Ensures program compliance with all policies and procedures related to project management, contract relations, purchasing, and fiscal planning Assists in the preparation of program reports, including monthly updates and quarterly, semi-annual, and annual reports Coordinates meeting management support for the assigned projects and programs, including drafting agendas, taking meeting notes/minutes and recording and monitoring action items for initiative committees, sub-committees, peer review panels, external advisory panels, scrum teams, program reviews, and other stakeholders as needed Communicates effectively with senior-level leads within the Health System, School of Medicine, and the University to compose both business and scientific documents and ensure smooth operations of the Program Maintain all status related communications with internal and external stakeholders (i.e., affected parties) Special Knowledge, Skills & Abilities Experience leading a variety of multi-person projects simultaneously and comfortable switching gears depending on business requirements. Ability to work effectively with diverse stakeholders, including highly collaborative multi - PI grants, faculty, academic leadership, and staff. Experience managing diverse teams including resources with divergent skills (e.g technical, clinical, analytics) to achieve harmonized research data provision supporting network or individual study objectives. Expertise leading teams responsible for cross-platform research data acquisition and management. Strong attention to detail and highly organized. Proficiency with project management tools, MS Project, MS Excel, MS Word, MS Teams, MS Visio Virtual/cloud based data management and administration including regulated security and privacy configurations required for research (IRB, HIPPA.) Compliance and information security as relations to Deep understanding of complex EMR, Research and Public Health system workflows with a focus on data generation and exchange. Familiarity with healthcare data organization, storage, cataloging, and analytics Familiarity with complex research data management tools, standards, and techniques that support various modes of data ingestion and curation. Bonus familiarities with ontologies and/or coding systems such as ICD, CPT, LOINC and MedDRA. Bonus Familiarity with the Observational Medical Outcomes Partnership (OMOP), Observational Health Data Sciences and Informatics (OHDSI) tooling, and Research Electronic Data Capture (REDCap). Bonus Experience with Cerner Electronical Medical Record System Bonus Experience with Amazon Web Services and their offerings Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Want to learn more about this role and Jobot Consulting? Click our Jobot Consulting logo and follow our LinkedIn page! Seniority level Seniority level Not Applicable Employment type Employment type Contract Job function Job function Project Management and Information Technology Industries Software Development, Technology, Information and Internet, and Technology, Information and Media Referrals increase your chances of interviewing at Jobot Consulting by 2x Get notified about new Clinical Research Project Manager jobs in Portland, OR . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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Clinical Research Associate, Sponsor Dedicated
Posted 3 days ago
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Job Description
Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Requires at least 2 years of year of on-site monitoring experience. Req
- Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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