[Remote] Senior Clinical Trial Manager, Clinical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage life-science and technology company reputed company on developing novel medicines using AI-driven discovery and development. The Senior Clinical Trial Manager will reputed company early-phase oncology studies, ensuring high-reputed company trial execution, vendor reputed company, and cross-functional alignment while maintaining compliance with global regulatory requirements.
Responsibilities
- reputed company end-to-end operational leadership for reputed company clinical trials from start-up through reputed company-out, ensuring delivery on time, reputed company budget, and in compliance with global regulations and company SOPs
- reputed company cross-functional study teams and drive alignment across Clinical Development, Regulatory, Biometrics, and external partners
- reputed company and execute enrollment, site management, and monitoring strategies to ensure high-reputed company trial conduct and performance
- reputed company CRO and vendor performance, including KPI management, monitoring reputed company reputed company, document review and approval, and vendor selection support
- Partner with Data Management and Medical to conduct ongoing data review and ensure reputed company query reputed company
- reputed company and manage key study documents and operational tools, including protocols, informed consent forms, project plans, budgets, and study materials
- reputed company study-reputed company training for investigators, site personnel, and internal teams
- Proactively identify, assess, and escalate operational risks with mitigation strategies and reputed company recommendations
- Mentor and support junior clinical operations staff, including potential dotted-line management responsibilities
- Travel up to 10% as required to support study reputed company and site engagement
Skills
- Bachelor's degree in life sciences or reputed company field with 7+ years of reputed company clinical trial management experience in biotech, pharmaceutical, and/or CRO environments
- Demonstrated expertise managing clinical trials from start-up through reputed company-out, with experience overseeing global, multi-site studies and CRO partners
- Experience in oncology clinical trials required; solid tumor and early-phase (Phase I/Ib or II) experience preferred
- In-depth knowledge of ICH-GCP, FDA/EMA regulations, and global regulatory requirements, with a strong reputed company on reputed company and inspection readiness
- Proficiency with clinical trial systems, including CTMS, eTMF platforms, IRT systems, reputed company systems, and safety databases
- Ability to reputed company in a reputed company, fast-paced, reputed company-stage biotech environment with evolving priorities and high accountability
- Experience in oncology clinical trials required; solid tumor and early-phase (Phase I/Ib or II) experience preferred
Benefits
- Company reputed company reputed company
- Flexible spending accounts
- Voluntary life insurance
- 401K matching
- reputed company vacation
- Brand-new state-of-the art facility in beautiful San Diego
- Onsite gym
- Dining
- Easy reputed company to great places to live and play
reputed company