Senior Clinical Trial Manager - Biotech

What you will be Doing

Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:

• Coordinate site management activities:
• Site identification, recruitment, and selection.
• Regulatory document collection and review.
• Overall scheduling and management of all site visits.
• Develop site/monitoring tools and training materials.
• Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
• Coordinate and oversee daily operations of clinical monitoring team:
• Set and enforce project timelines with the assigned study team.
• Coordinate remote review of clinical data within EDC system.
• Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.
• Review and approve trip reports and follow-up letters within required timeframe.
• Manage quality and regulatory compliance among clinical monitoring team and investigational sites.
• Manage project milestones and proactively address deficiencies

Manage CRA performance:

• Define and implement functional standards, goals, and expectations with clinical monitoring team.
• Serve as CRA mentor and perform accompanied field assessment visits as required.
• Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.
• Documentation Duties/Responsibilities:
• Assure that the appropriate SOPs are followed.
• Ensure all project documentation is appropriately filed per SOPs.
• Assist PM in preparation of audit responses, as appropriate.

Required Experience

• Thorough knowledge of clinical research process.
• Strong communication skills (verbal and written) to express complex ideas.
• Excellent organizational and interpersonal skills.
• Ability to manage multiple priorities within various clinical trials.
• Ability to reason independently and recommend specific solutions in clinical settings.
• Understanding of basic data processing functions, including electronic data capture.
• Working knowledge of current ICH GCP guidelines and applicable regulations.
• Ability to work independently, prioritize and work with a matrix team environment is essential.
• Prior experience in electronic data capture (EDC) preferred.
• Able to mentor CRAs and more junior Clinical Trial Managers.

• BS/BA (or equivalent) in one of the life sciences and a minimum of 4 years direct experience in clinical studies
• Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis
• Minimum of 2 years as a successful Lead CRA or Clinical Trial Manager.