Regional Clinical Study Manager - Oncology/ Solid Tumor

4+ years

$158K-$194K / yr. (est.)

San Mateo

10 March 3, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regional Clinical Study Manager – Oncology/Solid Tumor (San Mateo, CA)

Location: San Mateo, CA
Salary Range: $158,000 - $194,000 per year (Estimated)
Employment Type: Full-Time

Position Summary:

The Regional Clinical Study Manager will be responsible for delivering regional clinical studies with high-quality inspection readiness, within agreed timelines and budgets. This role will lead the regional clinical operations team, oversee external vendors, and act as the primary escalation point for study-related issues.

Key Responsibilities:

Regional Leadership:

Lead and manage the regional clinical operations team, ensuring effective decision-making and issue resolution.
Oversee external vendors involved in study delivery at the regional level.
Collaborate with key stakeholders and provide study progress updates to senior management and the Global Clinical Study Manager.
Represent the regional study team in internal meetings and cross-functional Clinical Study Team (CST) meetings.
Conduct regional operations meetings with all study team members.

Timelines, Planning & Execution:

Lead planning and management of assigned clinical studies from feasibility to closeout for the region.
Track and maintain high-quality study start-up and recruitment timelines.
Ensure regional feasibility, country allocation, and site selection in collaboration with feasibility managers and stakeholders.
Provide regional input on global study plans.
Manage local adaptations of global study documents, ensuring timely submission to regulatory authorities and ethics committees.
Oversee regulatory submissions and approvals in collaboration with regional study start-up teams.
Ensure up-to-date and accurate study information in study systems and tools.
Collaborate with CRAs to ensure effective study execution at sites.
Manage Trial Master File (TMF) quality control and maintenance for the region.
Work with Global Clinical Supplies on drug inventory management and label reviews.
Oversee trial data collection, query resolution, and data entry compliance.
Support Clinical Study Report (CSR) planning and execution with Global Clinical Study Manager and Medical Writing teams.

Quality & Compliance:

Resolve escalated study site issues and ensure compliance with protocols, SOPs, and ICH/GCP regulations.
Maintain inspection readiness throughout the study lifecycle.
Identify and address study-related risks, implementing mitigation strategies.
Prepare study sites for audits and inspections, ensuring prompt responses to findings.
Share cross-functional best practices and lead process improvements for efficiency and quality.

Budget & Resource Management:

Select and manage regional study vendors in collaboration with the sourcing team.
Oversee regional study budgets, investigator fees, and site payments.
Address patient travel reimbursement and site financial issues with Clinical Business Operations.
Assess and allocate regional team resources, establishing contingency plans.

Supervisory Responsibilities:

Provide performance feedback for team members.
Mentor junior clinical research professionals as needed.

Required Qualifications:

Education: Bachelor’s Degree in a scientific or healthcare discipline required; higher degree preferred.
Experience:
- 4+ years in clinical research within biotech, pharma, or CRO industries.
- Previous leadership experience in clinical operations.
- Prior CRA experience is preferred.
Skills & Knowledge:
- Strong understanding of clinical research processes, regulatory requirements, and ICH/GCP guidelines.
- Proficiency in MS Office and project planning applications.
- Experience in vendor selection, budgeting, and study management.
- Excellent organizational, leadership, and communication skills.
Travel: May be required based on business needs.

Apply now to join a dynamic clinical research team dedicated to advancing oncology and solid tumor therapies.

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