Full time assignment to last through December 2023 with possibility to extend.

The Senior Clinical Project Manager (Sr. CPM) will serve as an expert on the operational delivery of clinical trials in alignment with overall program strategies and milestones.  The Sr. CPM will assist and support the Clinical Operations Project Lead (COPL) to manage the internal and outsourced cross functional study team(s).  The Sr. CPM will be responsible for oversight of the timelines and budgets for the clinical studies and associated vendors, proactively managing operational risk and will support the execution of these studies according to time, cost, and quality targets.

Accountability Supporting Activities

*may include but not limited to the following:

Clinical Trial Operational Delivery

• Defines and provides optimal overall operational strategy and management of the program/protocol’s study development, timelines, budgets, resourcing, and quality targets for execution of the clinical plan

• Oversees Vendor/Contract Research Organization (CRO) and all study-related activities

• Establishes and provides leadership of cross‑functional teams to clinical trial delivery

• Functions as the single point of accountability for overall study delivery from study start-up and vendor selection through CSR (submission to defense) in partnership with the COPL

• Monitors clinical trial execution against study/program plan

• Attends and represents Clinical Operations at governance meetings

Collaborative Relationships

• Leads and manages in an ambiguous, dynamic environment

• Facilitates cross-functional team communication and effectiveness

• Provides high quality study information to support timely decision making

• Develops, motivates, and supports positive project-related study team dynamics

• Utilizes a disciplined project and risk management approach 

Overall Study Health/Risk Mitigation

• Identifies study level opportunities and risks

• Prepares, maintains, and implements risk mitigation, corrective and preventative action, and contingency plans

• Leads the team in managing issues and provides effective problem solving strategies

• Manages critical changes and/or variance in financial forecast, schedule scope and deliverables

• Facilitates communication with key stakeholders/senior management to inform and align agreement with the study/program level major risks/opportunities and corresponding contingency/mitigation plans

Compliance with Parexel standards

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• Professional clinical trial leader with strong interpersonal and communication skills to effectively lead internal and external cross-functional teams who can serve as a primary point of contact in the governance of assigned clinical trials

• Critical thinker who can identify, escalate, and resolve project related issues

• Strong, methodical organizational skills and the ability to work in a dynamic environment

• Effective verbal, written, and presentation communication skills with the ability to understand and assimilate high-level data to and from all functions

• Proficient with MS Office Suite (Excel, Word, and PowerPoint)

• Proficient in written and spoken English required

Knowledge and Experience:

• At least 12 years of demonstrated significant leadership experience in clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associated with clinical trial project and study management

• Working knowledge of Good Clinical Practice, monitoring, clinical, and regulatory operations

• Experience in vendor and/or CRO oversight

• Experience in managing and overseeing study budgets

Education:

• Bachelor of Science or Master of Science/PhD with significant relevant experience