Senior Clinical Project Manager at Merit Medical Systems Inc in Rockland, MA

Responsible for planning, executing, managing and monitoring complex clinical research projects.

ESSENTIAL FUNCTIONS PERFORMED

1. Develops and oversees study operational plans.
2. Contributes in external vendor qualifications and selection related to clinical trials.
3. Manage CRO and other external vendors supporting clinical studies.
4. Participates in the design, planning and execution of multiple phases of clinical trials to GCP and IHC standards.
5. Oversees and ensures adherence to GCP and ICH guidelines, regulatory requirements, SOPs, and protocols; takes ownership for data completion and accuracy.
6. Contributes to clinical site interactions, including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.
7. Contributes to study team for trial start-up, conduct and close-out activities according to industry and corporate standards.
8. Participate in study data review and assists with patient outcome narrative writing and other data review activities as assigned.
9. Oversees and participates in initiation, training and monitoring activities at clinical trial sites.
10. Contributes to creation of study documentation including clinical protocols, study tools, informed consent, investigator brochures, and clinical study reports.
11. May lead the work of Clinical Project Managers by training, mentoring, supervising work projects, etc.
12. Performs other duties and tasks, as required.

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelor's Degree in science discipline such as Biology, Chemistry, etc. or Life Science, etc.
• Eight years of experience in the medical device, pharmaceutical drug development, biotech or CRO industries.
• Excellent knowledge of ICH/GCP including relevant Guidance documents from FDA, ICH, and EMEA, etc.
• Experience in clinical trial site monitoring.
• Experience managing outside vendors such as CRO's, consultants, and other subcontractors.
• Demonstrated effective verbal and written communication skills; fosters smooth flow of timely and relevant information.
• Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
• Strong organizational skills and the ability to be self-motivated and be detailed oriented.
• Experience interfacing with multiple vendors/contractors.
• Proven ability to handle multiple projects and changing priorities.
• Must be results-driven and exhibit a sense of responsibility and outcome ownership.
• Ability to travel to clinical sites, domestic and foreign, up to 25%.