The Clinical Program Manager (CPM) is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements across the globe. In addition, the individual will contribute to the development of SOPs, clinical development plans, and other company initiatives as required.  This position reports to Senior Director, Clinical Program Management. 

Responsibilities

• Manage one or more assigned global clinical studies encompassing all aspects from start-up through close-out (reconciliation of Trial Master File)

• May serve as subject matter expert (SME) in one or more areas such as systems, tools, best in class standards for operational execution etc.

• Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function

• Works cross functionally to develop internal work processes

• Collaborates with Clinical Program Management leadership on the growth of department

• Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws

• Coaches and provides guidance to clinical staff, may have management responsibilities for clinical trial management staff

• Coordinates and assists in the planning of regulatory or ethics committee activities for the clinical study, as appropriate.

• Ensures audit-ready condition of clinical trial documentation including trial master file;

• Proactively identify and resolve issues and manage escalation as appropriate.

• Participates in the planning of quality assurance activities and coordinates resolution of audit findings;

• Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs:

• Develop and manage study budget and maintain within financial goals; Responsible for study budgets up to $100M

• Co-leads development of clinical study synopsis and protocol in conjunction with the clinical development plan

• Plans, executes, and leads study-specific meetings (e.g., Study Management Meetings, investigator meetings, etc.);

• Drives selection and management/oversight of external vendors including key performance indicators and participates, as applicable, in vendor management governance;

• Develops and manages comprehensive study timelines and metrics

Qualifications

• Bachelor’s Degree in science or a health-related field is required; advanced degree preferred

• 6 to 8 years of direct clinical trial management experience in the biotech/pharmaceutical industry

• Must have multi-trial, Phase 2/3, global experience as a lead study manager

• Excellent knowledge of GCP, ICH, and FDA regulations with direct experience with health authority inspections

• Must be able to travel up to 20%

• Demonstrated leadership, problem solving, conflict resolution, and team building skills

• Excellent written and oral communication skills

• Strong management skills, and ability to effectively lead and collaborate with both internal and external stakeholders

• Experience in multiple therapeutic areas or disease state/indications desirable, including life cycle management

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