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Job type: Contract

Discipline: Clinical Trial Assistant (CTA)

Location: United States

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

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