Sr. Clinical Trial Manager - Contract - Boston, MA
Are you looking to drive groundbreaking medical research and make a real impact-join us as a Sr. Clinical Trial Manager and lead the way in advancing clinical trials!
Primary Responsibilities:
This role involves managing trial start-up, maintenance, and closure while ensuring compliance with ICH-GCP standards and internal policies. You will play a crucial role in maintaining data integrity and quality across projects, working closely with vendors and stakeholders.
Skills & Requirements:
- Experience in leading clinical operations for Neuro and Cell & Gene Therapy trials.
- Strong understanding of ICH-GCP guidelines and clinical trial regulations.
- Excellent project management and leadership skills.
- Ability to manage multiple stakeholders and cross-functional teams.
- Proficiency in maintaining trial documentation and ensuring inspection readiness.
- Strong problem-solving skills and ability to propose process improvements.
- Effective communication skills for interacting with external partners and vendors.
The Sr. Clinical Trial Manager's responsibilities will be:
- Lead clinical trial operations, ensuring adherence to timelines, budget, and scope.
- Ensure compliance and quality management, maintaining accurate documentation and trial master files.
- Define and execute quality control steps, including study performance metrics.
- Guide and manage stakeholder communications regarding clinical trial information.
- Oversee clinical monitoring activities and ensure regulatory compliance.
- Support Trial Master File strategy and inspection readiness activities.
- Coordinate data review activities and manage protocol deviation reviews.
- Provide clinical supply projections and approve demand.
- Lead project team meetings and mentor team members.
- Contribute to study protocol development and clinical system design.
- Conduct study feasibility and ensure proper site selection and setup.
- Serve as the primary contact for project communication and coordination.
If you are having difficulty in applying or if you have any questions, please contact Bo Forsen at b.forsen@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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