Clinical Project Manager

SUMMARY:

The primary responsibility of this position is the design and execution of clinical studies in the development and approval of medical devices for human use. As such, the individual will work with both internal and external personnel such as engineers, market and/or product managements, statisticians, clinical research associates, physicians, programmers and others involved with the planning and implementation of clinical trials. This position has the responsibility to ensure, either through their own direct efforts or through others, (i) there is adequate project planning, (ii) there are adequate resources available (time, funding and personnel), (iii) each project is successfully initiated, conducted and terminated.

ESSENTIAL FUNCTIONS:

The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.

1. Responsible for developing a project plan, usually in the form of a Gantt or PERT chart. The plan needs to include what tasks need to be completed, who is responsible for each task and the expected duration for completion of the task.
2. Initiate protocol development and case report forms in accordance with US and international regulations, corporate and divisional procedures and policies.
3. Negotiate and coordinate agreements and contracts; e.g., investigator agreements, CRO contracts, core lab contracts, etc.
4. Initiate clinical studies including investigational review board or ethics committee approval, training of site personnel and CRAs.
5. Monitor clinical sites.
6. Complete, coordinate and/or oversee task completion; including device accountability, payment management and working with CROs, data management centers, core labs, clinical events committees, project teams.
7. Assure compliance with SOPs, the protocol and US and international regulations (including scheduling of audits).
8. Develop, maintain and track budgets.
9. Generate reports.
10. Develop and maintain written internal procedures for the clinical operation.
11. May be responsible for supervising employees or individuals outside of of company who are involved with clinical trails and data management.

NON-ESSENTIAL FUNCTIONS:

In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.

QUALIFICATIONS:

1. Bachelor’s degree (or equivalent) and a background in a life science, health science or related field.
2. Four to five years of clinical research experience with two plus years of broad senior clinical research associate experience either in medical devices (preferred) or biologics or pharmaceuticals (including a reasonable amount of experience in the management of outside organizations, such as CROs).
3. Excellent written and verbal communications skills.