Senior Clinical Trial Manager, Clinical Operations

Senior Clinical Trial Manager, Clinical Operations

Bay Area company has an exciting opportunity for a Senior Clinical Trial Manager within Clinical Operations. The successful candidate will be responsible to ensure clinical trial strategy is executed on time, within budget, and of high quality.
Key Responsibilities:
• Lead the overall clinical operations activities across all clinical studies for a clinical development program.
• Build strong relationships with clinical sites and primary investigators, facilitating timely site activation, enrollment, and data delivery.
• Assist in the identification and development of Clinical Operations staff and infrastructure.
• Manage operational implementation of clinical trials throughout the life of each trial to facilitate timely evaluation of trial endpoints, meet overall program goals and objectives, and ensure ongoing regulatory and GCP compliance (i.e., inspection ready at all times).
• Serve as the lead point of contact between for CRO(s), responsible for coordinating internal and managing external cross-functional activities to ensure delivery of critical clinical deliverables, including development of trial documents (e.g., informed consent forms (ICFs); protocols; site and country budget templates; EDC, IRT, central/specialty lab, ECG, imaging, and PRO specifications; drug supply and biomarker/sample management plans; and CSRs) and delivery of trial data (e.g., ongoing data capture, cleaning and availability, periodic and ad hoc generation of interim data, etc.).
• Develop and manage project timelines (utilizing MS Project or equivalent software), study budgets, and study plans.
• Periodically report project status to senior management.
• Manage activities performed by consultants, CROs and vendors including initial identification of a suitable partner, delineation of regulatory obligations, preparation of communication plan(s), review of monthly status reports, ongoing oversight to ensure delivery against contracted scope of work, and interactive management to ensure project success.
• Contribute to development of trial related documentation (protocols, case report forms, consent documents, letters of agreement, confidentiality agreements).
• Participate in vendor selection (Request for Proposal (RFP) process) in collaboration with cross-functional team members.
• Contribute to site selection
• Contribute to the development and active management of study-specific patient recruitment strategies.

Job Requirements:

• BA/BS degree with at least 5 years clinical trial experience (including oncology drug development)
• Must have strong knowledge of ICH/GCP guidelines
• Must have strong knowledge of clinical drug development processes, clinical study design, study planning and management, and monitoring
• Strong experience in management of CROs and other vendors
• Proven project management skills and study leadership ability
• Excellent interpersonal, written, and verbal communication skills
• Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
• 5+ years functional experience with managing clinical trials, including risk assessment and contingency planning.
• Experienced in managing aspects of one or more early development phase (I and II),
• global, complex, clinical studies and generally experienced in clinical research/development.
• Self-motivated, achievement-driven and exhibits ability to work with minimal guidance.