Job Description

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:

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

Desired Skills and Experience

Clinical Program Manager, Clinical Operations, Clinical Study Execution Team (CSET), trial timelines, trial execution strategy, audit readiness, TMF compliance, protocol development, ICF drafting, CRF development, monitoring plans, cross-functional collaboration, process standardization, RFP development, CRO management, vendor selection, vendor oversight, investigator training, study coordinator training, study budget development, Clinical Trial Manager mentoring, CTMA supervision, CTA training, risk management, contingency planning, scenario planning, FDA regulations, EMA regulations, ICH Guidelines, GCP compliance, clinical operating procedures, strategic thinking, program-level planning, operational data analysis, decision-making, multitasking, task prioritization, eTMF systems, EDC platforms, IRT systems, CTMS experience, oncology trials, early stage clinical trials, late stage clinical trials, pharmaceutical industry experience, biotech industry experience, clinical research, interdisciplinary team leadership, quality assurance, fiscal responsibility, external partner management, recruitment, hiring process participation

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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