Last Updated: October 25, 2017
The Senior Project Manager is responsible for all aspects of project administration and coordination of multiple large-scale, multi-center clinical trials. This includes the review of all proposals, budgets, and contracts and tracking of all milestones and timelines. The Senior Project Manager assumes the responsibility for bigger trials both in number and complexity than other Project Managers. The development of study related documents and overall direction of the clinical sites for protocol adherence is under the direction of the Project Manager. Independent decision making based upon current factors related to specifics of each clinical trial is required. The Senior Project Manager is responsible and accountable for assuring that the project team that he/she leads meets all deadlines and is also required to maintain a close effectual working relationship with Sponsors, Research Coordinators, and Principal Investigators. Mentors all other Project Managers in the conduct of clinical trials. Must be willing to serve on internal committees.
- Must demonstrate strong project management skills with the ability to manage cross-functional deliverables and timelines successfully
- Coordinate the development of project timelines and manage any changes thereto, including future timeline changes that may result from changes in scope, delays in schedule or resource constraints.
- Develop and finalize complete project plans with formalized project milestones and deliverable schedule
- Track milestones and report on progress to management
- Present and lead presentations at investigator meetings/Site initiations
- Facilitate and maintain records of all internal and external communication relevant to assigned projects
- Effectively manages external resources
- Coordinates all project and deliverable planning meetings
- Assists with CRF/MOP development
- Coordinates DSMBs including the selection of DSMB members, development of Charter, plans, schedules meetings and communicates report designs and timelines
- Oversee electronic data submissions
- Coordinates and documents data requests and facilitates communication of and completion of Contract Change Orders
- Tracks all study milestones and client deliverables
- Reviews all reports and client deliverables
- Maintain and develop client relationships
- Assist Business Development with the presentation and support for new project proposals
- Generally, serve as the primary coordinator of communication among all internal, external and sponsor project team members
- Prepare all study related reports on project performance for both internal and external stakeholders
- Present project performance at periodic project oversight meetings (Business Trial Strategy)
- Manage multiple-interdisciplinary teams as primary lead or project strategic lead in a Matrix Organization
Supervising Duties: Supervises and directs a Project Team including but not limited to Database Manager, Clinical reviewers, Biostatistician, Programmer, Safety and ancillary personnel needed to conduct a clinical trial. These positions report to their own department heads. Serves as a mentor/trainer for new Project Managers. Prepares and delivers annual performance reviews on these individuals.
Preferred: Masters (completed or in progress) or equivalent professional experience
Yrs. of related experience:
Required: 6+ years clinical trial management
Travel: Investigator meetings, site initiation meetings, professional conferences
- Must be knowledgeable in many therapeutic areas.
- Must have medical device experience.
- Must be able to prioritize multiple, competing tasks with excellent organizational skills.
To apply for this position, please submit a cover letter and resume.