2007-128 Clinical Project Manager **

Description
JOB SUMMARY: Participate in the management of clinical investigations conducted by JOB SUMMARY: Participate in the management of clinical investigations conducted by Terumo Medical Corporation from initiation of the study to close out of study including delivery of the final study report. Provide investigational site management. Develop achievable key milestones for trial and manage resources to meet these milestones. Assure study activities comply with Good Clinical Practices/other relevant FDA regulations, with other applicable international standards, with specific state or country regulations, and with Terumo policies and procedures.

DUTIES AND RESPONSIBILITIES:
1. Acquire and maintain a current knowledge of 1) federal/state/local regulations pertaining to the lawful conduct of clinical investigations, 2) applicable international standards, 3) specific country regulations, and 4) Terumo policies and procedures.
2. Determine appropriate regulatory requirements, identify resource strategies (including outsourcing resources) for clinical investigations, and manage external vendors (e.g. central labs, CRO's, etc).
3. Prepare achievable key milestone timeline for the clinical investigation and participate in managing resources to meet the milestones (e.g. track patient enrollment, IRB approvals, etc.).
4. Act as key focus of managing clinical investigations both internally and externally.
5. Coordinate investigational site selection and qualification; assist with budget/contract negotiations; and oversee site initiation, monitoring and closeout visits.
6. Assure required documentation is obtained, filed and appropriately archived per applicable regulations.
7. Prepare and manage trial budget execute/manage payments.
8. Coordinate data management activities.
9. Manage and maintain appropriate accountability records for the study product.
10. Provide management with periodic updated project status reports.
11. Performs regulatory duties as assigned.
12. Participates in clinical project performance team meetings on behalf of the job unit in order to provide ideas, methods or processes for unit/company performance improvement.
13. Assist as needed with other regulatory duties.
14. Performs other job related duties as assigned.


Position Requirements
MINIMUM QUALIFICATIONS:
1. Must have demonstrated successful management of key aspects of at least 2 medical device clinical investigations and exhibit superior interpersonal communication (verbal and written), organizational skills, ability for independent work as well as team participation, and decision-making skills.
2. Ability to make correct prioritization decisions and to manage and provide leadership to resources in order to meet key milestones.
4. Handle multiple simultaneous projects with attention to detail and a commitment to high quality deliverables.
5. Position exists in an office environment.
6. Expected travel: average 3-5 days/nights per month, e.g. educational activities, vendor visits, investigational site visits, etc.

Preferred Qualification:
Regulatory Affairs Certification preferred.



Educational Requirements
Typically requires a 4-year degree in life sciences coupled with 3-4 years experience in clinical investigations project management.

Full-Time/Part-Time
Full-Time

Shift
First

Department
Clinical Projects