Clinical Trial Manager
171 Oyster Point Blvd , Suite 500 South San Francisco, CA 94080 US
A Clinical Trial Manager plays an essential role in the support of development and implementation of global clinical studies by providing significant tactical management for assigned projects and contributes to development and implementation of operational strategies and clinical trial designs.
Responsibilities include supporting the planning, execution, and interpretation of global clinical trials and ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registrations and commercialization of company products
• Manage all operational aspects of assigned clinical trial(s). Support the selection of vendors/CROs and provide effective ongoing management to vendors/CROs to ensure compliance and execution of deliverables within the approved budget, study timeline, and study protocol. Independently manages less complex studies
• Monitor and track clinical trial progress and provide status update to stakeholders and at project team meetings to Sr Management as needed.
• Manage or support the Management of study contracting, budget, forecasting, accruals, and payment process for all clinical trial vendors including investigational sites
• Oversee all aspects of data cleaning and facilitate data locks, including oversight of clinical sites, CRO, vendors and collaboration with data management/statistics teams
• Draft and coordinate review of relevant documents including protocols, informed consents, monitoring plans, with little supervision.
• Must be able to participate in cross-functional strategic initiatives under limited supervision.
• Proactively identify potential issues/risks and recommend/implement solutions. Facilitate and SMT for assigned projects. Prepare and/or present written and oral presentations regarding clinical trial progress/results internally and externally.
• Participate in clinical development initiatives such as clinical standard operating procedures, eTMF, etc.
• Develop and maintain relationships with key opinion leaders (KOLs) and clinical scientists to support Tenaya development activities on a global basis.
• May have direct reports
• Participates in the recruiting and hiring process for CPA/CTMAs and supports their professional development
• Coach members of a work team and ensures adherence to established guidelines
• A minimum of seven (7) years of Clinical Research experience, preferably in rare and/or cardiovascular disease with a BS degree in a scientific discipline, RN, BSN degree or equivalent. A MS, PharmD and/or PhD may be considered with less than five (5) years of related Clinical Research experience.
• Ability to travel as required for the program (less than 10%).
• Demonstrated knowledge of FDA, ICH and GCP regulations and guidelines.
• Experience in leading teams, including CROs, consultants and vendors.
• Must display strong analytical and problem-solving skills at a project level and collaborate with colleagues to generate solutions.
• Strong communication and influence skills and ability to create a clear sense of direction.
• Ability to deal with time demands, incomplete information or unexpected events.
• Outstanding organizational skills with the ability to multi-task and prioritize.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
*Pay rate between 75-105 per hour
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