FSP Senior Clinical Project Manager

About ExecuPharm

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Position Purpose:

A Senior Clinical Project Manager (Senior CPM) is responsible for the execution of a clinical trial or suite of clinical trials from protocol design to the final clinical study report. The position is responsible for coordinating all efforts for the trial both within the Company and through a wide variety of vendors. The position coordinates other functional groups that comprise the clinical department indication team for the product; specifically, statistics, clinical monitoring, data management, medical writing, medical and safety to insure proper conduct and timely completion of all projects.

Primary Duties:

· Optimizes processes for projections including cost, enrollment and Investigational Product forecasting.

· Implements standardized project plans and planning processes.

· Implements an efficient contracting and vendor selection process.

· Establishes efficient vendor management processes.

· Establishes standardized metrics and optimal reporting formats.

· Participates in, or leads, infrastructure development project teams to enhance department growth

Specific duties include but are not limited to:

· Manages cross functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s).

· Drives all aspects of the project management process from initiation, planning, execution, control and closure. Manages all aspects proactively.

· Creates project budgets and manages cost to budgets. Develops enrollment projection, and drug supply needs as part of the budget.

· Responsible for creating Project Plans (e.g. Responsibility Table, and Communication Plans) and Study Data Sheet for each project.

· Reviews and approves the site contract template and budget template. Will review and approve any variations to the template.

· Reviews study-related support materials created by the Monitoring and Data Management Groups (e.g. study manual, monitoring plan, edit check manual, Listing Review process).

· Responsible for periodic (weekly, or as needed) clinical trial team meetings.

· Position has overall responsibility to deliver the projects on time and on budget. The CPM drives study conduct to timely completion in compliance with all regulations and SOPs.

· Requires the ability to negotiate and manage competing priorities across multiple functional areas.

· Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects.

· Ensures all groups provide deliverables (i.e. query generation and resolution, data base lock, study report). Informs all groups of deliverables and timeline, project developments and insures completion according to timelines.

· Manages and coordinates all vendors involved in the clinical trials, e.g. central lab, CROs, including managing the Request for Proposal processes and overall budget for each.

QualificationsSkills and Education:

· BA/BS or equivalent experience with at least 8 years of pharmaceutical/biotech clinical development experience An advanced degree (Master’s or PhD), oncology/hematology clinical trial experience, and NDA/BLA filing experience are preferred.

· Experience must include Phase I-III trials, CRO management, significant experience managing international clinical trials, and project and contract management.

· Expertise with MS Project and Excel; Project Management Certification (PMP) is suggested

· Demonstrated ability to manage and coordinate senior level scientific management personnel and to resolve project issues across organizations.

· Excellent communication, leadership, conflict resolution, risk management, delegation, decision-making and documentation skills.

· Ability to apply project management disciplines, including adherence to corporate financial plans and operating strategies and the ability to direct the actions of project team personnel as appropriate.

· Demonstrated ability to think and act strategically, tactically and operationally as well as proven ability to plan, identify risks, anticipate various outcomes and, balance short-term and long-range objectives

10% travelEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.