Senior Clinical Trials Manager

Job Type Full-time Description

BioAge Labs is a venture-backed biopharmaceutical company headquartered in Richmond, CA.  Because aging is the driver of many highly morbid, chronic medical conditions that reduce the length and quality of life, we are developing therapeutics that target the fundamental mechanisms of aging, with the goal of treating disease and increasing healthy lifespan.

We are seeking a Senior Clinical Trials Manager (Sr. CTM) to independently manage and lead all aspects of one or more clinical trials. 

The job: Ensure trials are completed on-time, within budget, and meet appropriate quality standards. Lead cross-functional teams, build and manage study timelines, and oversee study vendors and contract research organizations to achieve key milestones. Work from anywhere with up to 30% travel.

You: A proven leader with 10+ years of experience managing clinical studies in biotech/pharma and a passion for developing new therapeutics targeting aging. Skilled at coordinating global trials, mitigating risks, and resolving issues. An excellent communicator with the ability to work independently.

Us: A leader in the emerging field of longevity biotech developing innovative treatments for age-related disease. A well-funded company with an important mission; competitive compensation and generous benefits; and a flexible, work-from-anywhere culture that emphasizes creativity, autonomy, and growth potential for all team members.

Responsibilities: 

• Ensure all clinical trial activities (regionally and/or globally) and deliverables are completed on-time, within budget and in accordance with appropriate quality standards / SOPs including ICH/GCP/FDA/EMA, etc. from start to finish
• Oversee monitoring activities related to feasibility, site qualification, site initiation, interim monitoring, and close-out visits.  This includes detailed report review and tracking of action items.
• Participate in the RFP process, including leading the evaluation, selection, and oversight of clinical vendors, clinical trial sites, CROs, etc.
• Ensure country/site start-up metrics are included in enrollment tracking scenarios to meet start-up and enrollment targets.
• Prepare risk assessment and risk mitigation strategies for each study and lead development and implementation of robust contingency, communication, and monitoring plans 
• Review and track the study budget (including vendor budgets, change orders, and out-of-scope activities) and invoices, including budget to actuals and budget forecasting 
• Manage multiple study vendors, including CROs, BioAge contractors, etc.
• Manage and oversee study timelines 
• Manage and oversee the Trial Master File for inspection readiness
• Manage study drug distribution, study drug accountability processes and documentation
• Develop and maintain study documents and tools, including study protocol, informed consent forms, project plans, budgets, logs / trackers templates, and newsletters
• Provide study status updates and reports to senior management
• Lead ongoing study data reviews and data cleaning activities, clearly communicating timelines and expectations with the internal team as well as pertinent vendors
• Facilitate and manage study site and vendor contracting / budget process (including budget negotiation)
• Develop and deliver training slide decks, ensuring input from each functional area to enable study training of CRO, internal staff, vendors, site staff and investigators on selected study processes
• Lead development of study-related systems (e.g. EDC, CTMS, eTMF) and processes, and oversee study supplies management
• Organize, facilitate, and lead internal Study Execution Team meetings and external CRO calls with CRO PM for assigned clinical study(s)
• Participate in preparation and follow-up of internal process audits, vendor, and site audits as well as regulatory authority inspections 
• Training and mentor new clinical operations staff
• Develop and implement clinical operations SOPs, tools, and trackers
• Up to 30% travel required

  Qualifications:

• BA/BS degree with minimum 10 years of study management experience in biotech or pharma
• Strong knowledge of GCP/ICH/FDA/EMA requirements
• Proven effective leadership, decision making, proactivity, and problem-solving skills required
• Strong knowledge and experience of global clinical study conduct, from start-up through close-out (CRO management experience required)
• Previous on-site monitoring experience required
• Previous experience on the Sponsor side is preferred
• Ability to work independently with minimal supervision and multi-task activities to effectively manage deliverables
• Expe