The Clinical Project Manager is responsible for managing and executing clinical studies from study initiation through study closeout, as well as assuring compliance with regulatory and quality procedures and standards. Support other related corporate initiatives, as required.
Review and approve protocols, study designs and reports for clinical studies.
Work with Regulatory Affairs to manage US and international regulatory submissions for the conduct of clinical studies and the approval/clearance of new products.
Support preparation of documents for the Design History File and for regulatory filings.
Manage CRO and/or other outside clinical study vendors.
Manage study timelines and budgets.
Drive clinical study communication to cross-functional teams.
Support data analysis and interpretation of clinical information.
Compile and summarize post market clinical information to support regulatory documentation.
Support other clinical activities within the department as needed, including tasks in support of Insulet-sponsored clinical studies.
Perform other duties as required.
Education and Experience
B.S. or B.A. (preferably in a Life Science field) or an equivalent combination of education and experience.
4-6 years of medical device or drug related clinical experience (with a minimum of 2 years direct project management experience preferred).
Endocrinology experience highly desired.
Must have analytical skill, be detail oriented and have good interpersonal skills.
Knowledge of agency guidelines and requirements.
Excellent written and effective verbal communication skills.
Proficient project management skills.
Ability to prioritize multiple timelines and tasks.
Ability to communicate at all levels of an organization.
PC skill, word processing, spreadsheet, database.
Internet search and utilization.
Flexible and able to work in a fast paced environment.