Clinical Project Manager/Coordinator (Onsite - Acton, MA)

Insulet Corporation•Acton, MA

20h•Onsite

About The Position

The Clinical Project Manager is responsible for managing and executing clinical studies from study initiation through study closeout, as well as assuring compliance with applicable regulatory and quality procedures and standards for the Next Generation Products (NGP) group. Lead the planning, execution, and reporting of early feasibility studies, internal evaluations and usability evaluations according to medical device regulations, as well as clinical research vendor selection and oversight. Support other related group initiatives, as required.

Requirements

B.S. or B.A. (preferably in a Life Science field) or an equivalent combination of education and experience.
3 to 5 years of medical device or drug related clinical experience (with a minimum of 2 years direct clinical project management experience preferred).
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.
Team player

Nice To Haves

Endocrinology experience highly desired.

Responsibilities

Coordinate and supervise study execution and contract management for internal and usability evaluations.
Review and approve protocols, informed consent forms, study designs and reports for clinical and human factors studies.
Work with NGP Regulatory Affairs to manage US and international regulatory submissions for the conduct of early feasibility and pilot clinical studies.
Collaborate cross-functionally in preparation of documents for necessary regulatory filings.
Proactively stay abreast of the latest regulations and GCP (Good Clinical Practice)
Support management of CRO and/or other outside clinical vendors.
Co-manage study timelines and budgets.
Drive clinical study communication to cross-functional teams.
Support review of data analysis and interpretation of clinical information.
Support other tasks related to NGP/Insulet-sponsored clinical trials.
Perform other duties as required