Clinical Trials Manager; Biotechnology Oncology

Clinical Trials Manager (Biotechnology Oncology)

Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of solid tumor oncology clinical trials. This position is responsible for overseeing the execution of clinical trials, collaborating with cross‑functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL).

Location: Onsite, Alameda, CA

• Manage clinical trials, including those conducted through CROs.
• Develop and recommend operational strategies for clinical trials in collaboration with cross‑functional teams.
• Oversee one to three external vendors and a specific geographical region.
• Engage with CROs, vendors, and sites for ongoing trial execution, including relationship management and quality/performance oversight.
• Oversee CRO activities related to site start‑up, maintenance, trip reports, protocol deviations, and data review.
• Participate in internal Study Delivery Team meetings and contribute to agenda preparation.
• Coordinate the preparation, conduct, and presentations at Investigator Meetings.
• Assist the Study Delivery Team and CRO in feasibility assessments and site selection.
• Assist with study protocol development, including informed consent forms, case report forms, monitoring plans, and other study materials.
• Maintain regular contact with Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, and other relevant departments.
• Ensure CRO compliance with protocol and Good Clinical Practice (GCP) guidelines.
• Proactively identify and communicate study issues, provide risk mitigation strategies, and escalates issues as needed.
• Provide support for adherence/compliance to study plans such as Verification of Performance (VOP).
• Oversee regulatory and essential documents.
• Support the development of study plans and documents including VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals.
• Coordinate the design, format, and content of study guides and subject instructions.
• Participate in strategic governance discussions as required (e.g., SAB, BOD).
• Review and provide oversight of study trackers and metrics.
• Provide oversight to the development and review of study documents such as protocol, ICF, CRFs, IRT specifications, product labels.
• Lead or contribute to departmental strategic initiatives or process improvements.
• Mentor and provide training to Senior Clinical Trial Specialists (CTS).

• Minimum of 7 years of life sciences experience, with at least 5 years in clinical research.
• Experience in study start‑up, maintenance, or close‑out.
• Experience in developing prospective site‑selection criteria.
• Protocol development experience.
• Working knowledge of ICH‑GCP Guidelines, local regulatory requirements, SOPs, and study‑specific procedures.
• Advanced concepts in clinical research.
• Strong organizational, planning, interpersonal, and communication skills.
• Ability to handle time constraints, incomplete information, and unexpected events.
• Experience interacting with outside vendors such as CROs and contract labs.
• Proficiency in writing and presenting scientific and clinical information.
• Team‑matrix environment competence and problem‑solving skill.

• BA/BS in biological sciences or related field with minimum 7 years experience; or
• MS/MA in biological sciences with minimum 5 years experience; or
• PhD/Pharm
  
  D in biological sciences with no required experience; or
• Equivalent combination of education and experience.

• Experience with site‑proposed ICF review for compliance.
• Strong written and oral communication with scientific terminology.
• Effective team and matrix collaboration.
• Technical, scientific, and medical information literacy.
• Professional collaboration and problem‑solving.

• Anticipate and resolve problems.
• Clear presentation of scientific and clinical issues.
• Effectiveness in team/matrix environment.
• Professional collaboration.
• Understanding departmental processes and implementing solutions.
• Escalation of broader impact issues.

• Analyze new situations and…