Senior Clinical Project Manager - ExecuPharm FSP

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. Additionally, a Senior CPM will participate and/or lead strategic level work, and lead group infrastructure development projects.

Primary Duties:

In addition to the descriptive and bulleted items below the Senior CPM may also perform some of the following duties but are not limited to:

· 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.

· Develops and maintains SOPs and work practices applicable to a global organization.

· Periodically reviews processes across clinical trial projects to ensure compliance and consistency.

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

· Lead strategic level work (e.g. partnership collaboration meetings, NDA level work, etc.)

The goal of the position is to drive development projects utilizing best practices in order to ensure budgets, timelines and performance requirements are met. Judgment is required to meet GCP, regulatory and SOPs and policies and to determine appropriate action. The role requires active involvement, to meet schedules or resolve problems or conflicts, and entails frequent interaction with subordinates, outside customers, functional peer groups at various management levels and senior management. Gaining project team cooperation, conducting presentations of technical information concerning specific projects and schedules and, solving technical problems, are keys to success.

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.

· Assists in developing protocol concept sheet (study design, entry criteria and schedule of activities table). Reviews protocol and CRFs and tracks development to completion.

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

· Responsible for creating and maintaining MS Project timelines for each project and uses these timelines to track and manage a project’s progress.

· 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.

Qualifications· 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

· Demonstrated expertise of CFR and GCP/ICH requirements, as well as European Clinical Trial Directive is required.

· Must be willing to travel up to 10%.

EEO 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.