Pivotal position with a medical device startup developing technologies for diabetes management. We aim to dramatically simplify insulin delivery, reducing the burden on both people with diabetes and the overall healthcare system. In this role, you will ensure study compliance with protocols, local regulatory standards and overall clinical objectives as well as provide leadership for the conduct of clinical studies and in the development of clinical evidence for pre-market trials/studies.
Global clinical trial strategy and execution, and outcomes research study design.
Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for high-profile, larger and more complex clinical trials through experienced team members in accordance to GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s)
Develop relationships with investigators and study coordinators
Develop study protocols, case report forms and related documentation
Oversee the selection of clinical vendors and study sites
Manage external contacts (clinical research organization, DSMB, CEC, MAB, investigators, site study coordinators, IRBs/ECs)
Work closely with Product Development, Marketing and Regulatory Affairs
Strength in relationship building through technical know-how; able to lead SME’S through influence and credibility.
Ability to participate and contribute to a systematic Stage Gate product development process.
Ability to multi-task between projects as directed by manager. Capable of performing under the pressure of multiple competing deadlines while maintaining a cooperative and constructive working relationship with colleagues is essential.
Outstanding verbal and written communication skills.
Willing and able to travel domestically and internationally
Bachelor's degree required and a minimum of 7 years of experience in clinical research/medical affairs with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of experience in clinical research/medical affairs with 5+ years of managerial experience
Managerial/leadership experience (i.e., experience as a manager having direct or indirect reports, people leader)
7+ years' experience managing multiple clinical research studies in medical device industry
Experience in medical device clinical product trials and regulations. Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trials.
Experience managing clinical trial operations from start to finish.
Internal Number: 31314
About Capillary Biomedical
Capillary Biomedical is a medical device startup developing technologies for diabetes management. We aim to dramatically simplify insulin delivery, reducing the burden on both patients and the overall healthcare system.