Job Description
Responsibilities
- Lead and oversee global and regional clinical programs, driving clinical strategy and successful study execution from start-up through study close-out.
- Manage, coach, and develop a team of Study Managers while ensuring effective resource planning across multiple clinical projects.
- Drive cross-functional collaboration with Regulatory Affairs, Medical Affairs, R&D, Biostatistics, Data Management, Safety, Marketing, and other key stakeholders.
- Build and maintain strong relationships with Key Opinion Leaders (KOLs), investigators, CROs, Core Labs, and other external partners.
- Oversee study timelines, clinical data reviews, safety activities, regulatory submissions, and governance meetings (e.g., DSMB/CEC).
- Lead vendor selection, contract oversight, and external partner performance to ensure high-quality study delivery.
- Contribute to clinical protocols, CRF development, scientific publications, and clinical evidence generation.
- Drive operational excellence through continuous process improvements while ensuring compliance with ICH-GCP, QMS, and applicable regulatory requirements.
What we are looking for
- Bachelor’s or Master’s degree in Life Sciences or a related scientific discipline.
- 7+ years of clinical research or Clinical Operations experience, including 5+ years within MedTech, medical devices, biotechnology, or pharmaceuticals.
- At least 3 years of people leadership experience, with a proven track record of developing and leading high-performing teams.
- Strong experience leading global or regional clinical programs, including clinical strategy, study oversight, vendor management, and resource planning.
- Deep knowledge of ICH-GCP, CFR requirements, clinical study operations, and regulatory compliance (FDA experience is an advantage).
- Experience working closely with KOLs, investigators, CROs, and cross-functional stakeholders in an international matrix organization.
- Background in Neurovascular is strongly preferred; experience in Cardiovascular or other interventional medical device therapies is highly desirable.
- Strategic, collaborative, and hands-on leadership style with the ability to thrive in a dynamic small- to mid-sized MedTech environment.
- Proficiency with CTMS, EDC systems, Microsoft Office, Microsoft Project, and other clinical project management tools.
- Willingness to travel up to 20% for investigator meetings, congresses, site visits, and internal project meetings.
Are you interested in this position?
Apply by clicking on the āApply Nowā button below!
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