Are you looking for a change?
Do you want to succeed in a company that values quality of life for its employees? Then consider working at Harvard Clinical Research Institute, Inc. (HCRI). HCRI is an academic research organization that provides integrative solutions to support clinical trials and other clinical research.

Working within the unique world-class patient care and research environment of the Harvard Medical School and affiliated institutions, we uphold the highest academic and ethical principles for patient-based research. HCRI facilitates interaction of existing scientific resources within its academic community and broadens interaction among clinical researchers and sponsors of research around the world.
HCRI is continuing to expand its leadership presence and currently has an opening for a Senior Clinical Project Manager.

Senior Clinical Project Managers are 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. 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 incumbent 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. Manages other personnel both directly and indirectly. Mentors all other Project Managers in the conduct of clinical trials. Must be willing to serve on internal committees. Serves as a mentor to new Project Managers.

Primary Duties:
1. Manage interdisciplinary team
2. Review proposals, budgets and contracts
3. Create timelines
4. Track milestones
5. Facilitate all internal and external communication
6. Mentor Project Managers
7. CRF/MOP development
8. Supervise subcontractors
9. Investigator meetings/Site initiations
10. Strong Management skills

Secondary Duties:
1. Coordinate DSMB’s
2. Oversight of data submissions
3. Coordination of data requests
4. Supervises development of reports
5. Review of reports
6. Assist with the development of departmental processes

Supervising Duties:
Supervises and directs a Project Team consisting of a Database Manager, Nurse Reviewer, Biostatistician, Programmer, Safety and ancillary personnel needed to conduct a clinical trial. These positions report to their own department heads. Project Managers are involved in the interviewing process. Is the primary mentor/trainer for all new Project Managers. Supervises at least one Admin and/or Research Assistant. Prepares and delivers annual performance reviews on these individuals.

Requirements:

Education:
Required: Masters (completed or in progress), or equivalent professional experience
Preferred: Masters plus Project Management Training

Related experience:
Required: 6+, clinical trial mgmt.
Preferred: 2-5 yrs HCRI experience
Must be knowledgeable in many therapeutic areas.
Must be able to prioritize multiple, competing tasks with excellent organizational skills.

Working Relationships:
Develops and communicates routinely with the Project Team involved in each trial. Consults with all department heads, the Medical Director, Chief Scientific Officer and Director of Project Management of Clinical Trials. Assists Director of Project Management of Clinical Trials on special projects. Utilizes clinical and/or clinical trial experience to provide on site scientific advice to ensure protocol adherence. Works with the financial personnel to ensure that trials are on budget. Establishes and maintains close working relationships in order to communicate effectively trial progress with study sponsors, principal investigators, research coordinators and study monitors.

Benefits:
HCRI is committed to excellence and competence and affords an environment of professional development and education that enhances the personal growth of its employees. HCRI also offers a full range benefits including health, dental and vision insurance, 3 weeks paid vacation, flex time, personal / sick time, 401K, pension plan, short and long term disability, tuition reimbursement, parking, discounted T passes and more!

Please visit our website: www.hcri.harvard.edu