Clinical Program Manager (CPM)

Bayside Solutions; California (MO); Hybride; USD 187 200 - 208 000; Plein temps

Résumé du poste

A dynamic healthcare solutions provider is seeking a Clinical Program Manager (CPM) to drive operational strategy across multiple clinical trials. The ideal candidate will have over 8 years of experience in the pharmaceutical or biotech industry, leading execution teams and ensuring compliance with all regulatory guidelines. This role involves high-level collaboration, strategic planning, and mentorship of junior staff. The position offers a competitive salary range and is hybrid in nature, covering key responsibilities in clinical operations.

Qualifications

• 8+ years of relevant experience in pharmaceutical or biotech industry.
• Independent application of clinical trial knowledge.
• High commitment to excellence in execution.

Responsabilités

• Drive operational strategy across clinical programs.
• Lead Clinical Study Execution Team (CSET) meetings.
• Oversee CROs and ensure study delivery.

Connaissances

Expert knowledge of FDA and EMA Regulations

High-level cross-functional collaboration

Strategic thinking

Formation

BS, BA, or RN in a relevant scientific discipline

Outils

Vendor systems/portals (eTMF, EDC, IRT, CTMS)

Description du poste

Clinical Program Manager (CPM)

W2 Contract-to-Hire

Salary Range: $187,200 - $208,000 per year

Location: Redwood City, CA - Hybrid Role

Job Summary

This is a unique opportunity for a Clinical Program Manager (CPM). You will be responsible for driving operational strategy across multiple trials within entire clinical programs or multiple trials across indications, and support program-level governance, timelines, and decision-making. This position will report into the Senior Director, Clinical Operations.

Duties and Responsibilities

• Provide expert thought leadership at the discipline level on highly complex and business-critical assignments and begin to develop new ideas.
• Lead the Clinical Study Execution Team (CSET) meetings and ensure trial timelines are met.
• Develop trial execution strategy and timelines across study(ies).
• Participate in multiple departments or interdepartmental strategic initiatives under limited supervision as they relate to study-specific initiatives.
• May serve as a resource for others with regard to a specific study trial.
• Maintain audit/inspection readiness and oversee TMF compliance.
• Collaborate with cross functional partners in drafting study documents such as protocols, ICFs, CRFs, monitoring plans, etc.
• Drive consistency in processes and tools across studies.
• Contribute to the development of RFPs and participate in the selection of CROs/vendors.
• May be asked to train CROs, vendors, investigators, and study coordinators, as well as cross-functional partners on study requirements.
• Oversee CROs, vendors, and key external partners to ensure study delivery.
• Make recommendations for the development of the study-level budget.
• Participate in the recruiting and hiring process.
• Mentor and train Clinical Trial Managers (CTMs), Clinical Trial Management Associates (CTMAs), and Clinical Trial Assistants (CTAs).
• Conduct risk management, contingency, and scenario planning.
• Participate in other Clinical Operations activities as appropriate.

Requirements and Qualifications

• BS, BA, or RN in a relevant scientific discipline.
• 8+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
• Expert knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.
• High-level cross-functional collaboration; strategic thinking across trials and functions.
• Strategic thinking across clinical trials and functions with strong program-level planning and risk management.
• Independently apply clinical trial knowledge to problems that arise during the study.
• High sense of priority and commitment to excellence in the successful execution of deliverables.
• Ability to analyze operational data, contribute with a mind on quality, timeliness, and fiscal responsibility, make and drive decisions, multitask, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
• Travel may be required (~25%).

Preferred Qualifications

• Has familiarity working with vendor systems/portals (eTMF, EDC, IRT, CTMS).
• Report to the oncology experience, early and/or late stage, strongly preferred.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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