Senior Clinical Trial Manager
Our client is a biotechnology company developing treatments to target cancer. They have asked us to assist them in their search for a Senior Clinical Trial Manager.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Oversees assigned clinical trial(s) to ensure deliverables are met in all phases of trials.
- Oversees trial feasibility process and site feasibility and capability assessments.
- Drives all aspects of the project management process from initiation, planning, execution, control, and closure.
- Leads the clinical trial team, and supports other development teams as a Clinical Operations representative.
- Identifies risks and leads team members to mitigation in a timely manner.
- Performs and documents study level sponsor oversight of outsourced clinical activities.
- Communicates study-status, cost, and issues to ensure timely decision-making by senior management.
- Initiate and manage study-level timelines, including communication to internal and external team members on deliverables.
- Reviews clinical data to ensure timely entry and readiness for data review meetings.
- Performs periodic review of clinical data, quality metrics and study deviations.
- Reviews and provides clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate.
- Manages laboratory samples to be sent to vendors in order to meet trial deliverables.
- Ensures trials are conducted in accordance with FDA and ICH/GCP regulations and guidelines.
- Participates in testing of clinical trial systems and databases.
- Ensures robust sample management is in place for assigned studies.
- Collaborates with the finance team to review and approve the site contract and budget template.
- Manages and reviews invoice and budget tracking for individual studies and provides input into budget forecasting activities.
- Develops and maintains positive relationships both internal and external to project, including site personnel.
- Provides input and review of the development of in-house operational SOPs, guidelines, and systems.
- Provides critical thinking and escalation when issues arise during execution of clinical studies.
- Oversees study-specific local clinical resources.
- Strives for continuous improvement and more efficient ways of working in clinical operations.
- A Bachelor’s degree or higher in life sciences is required.
- Must have at least seven years of experience in a clinical research and industry environment, including a minimum of three years of Sponsor and Biotech start-up experience.
- Experience with early phase complex trials is preferred, especially in immunology (rheumatology) and oncology phase I trials.
- Must have relevant experience across the entire lifecycle of a study.
- Requires a solid understanding of the drug development processes.
- Requires excellent project management and vendor management skills.
- The ability to work on cross-functional teams and provide clinical operations oversight and guidance is required.
- Requires an understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
- Must have excellent verbal and written communication skills.
- Excellent organizational skills and attention to detail are required.
- Requires the ability to be on site five days a week.
- Requires the ability to travel as needed.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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