Site: The General Hospital Corporation
Job Summary
Manages all recruitment and collection activities for the studies. Functions independently strategizing directly with the PIs. Responsible for the daily execution of principal duties and responsibilities and aspects of project management and administration including operational, budgetary, grant writing, communication, and research subject education components. Also responsible for direct supervision of all research coordinators.
Does this position require Patient Care?
No
Essential Functions
-Develops detailed protocol documents that meet federal institutional standards.
-Ensures study design's compatibility with clinical practices.
-Provides critical input as to feasibility of study design and available resources.
-Ensures document consistency.
-Responsible for developing/managing the clinical trial’s operating and capital budgets.
Education
Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred
Can this role accept experience in lieu of a degree?
No
Licenses and Credentials
Experience
Research Related Experience 5-7 years required and Supervisory Experience 3-5 years preferred
Knowledge, Skills and Abilities
- Ability to effectively supervise and train Staff.
- Excellent judgement and ability to interpret information and protocol.
- Ability to make independent effective decisions.
- Aptitude for technical problem solving.
- Excellent organizational abilities to formulate and complete rigorous timetables.
Additional Job Details (if applicable)
The Senior Clinical Research Program Manager is responsible for strategic and operational decision-making across a diverse portfolio of clinical research studies, including industry-sponsored and investigator-initiated, multi-site IDE trials, retrospective chart review studies, and registries. The ideal candidate will have experience and expertise in running investigator-held, multi-site IDE trials. In this role, you will oversee all aspects of study planning and execution, including timelines, budgets, and data management; lead a team of clinical research professionals, which may include research nurses, clinical research coordinators, data analysts, contract research organizations (CROs), and external vendors, to ensure deliverables are met; and collaborate with internal and external stakeholders to ensure studies are conducted efficiently and in compliance with Good Clinical Practice, FDA regulations, and IRB policies. Success in this role requires strong leadership and organizational skills, excellent communication skills, the ability to problem-solve with good judgment, a comprehensive understanding of clinical research processes, and the ability to proactively identify and mitigate risks and resolve operational challenges while driving process improvements.
Onsite
55 Fruit Street
40
Regular
Day (United States of America)
Pay Range
$78,936.00 - $128,928.80/Annual
Grade
8
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.