Project Manager- Princeton, NJ

The Company

Headquarters in Princeton, NJ, is one of the world's largest and most comprehensive drug development services companies with 2001 pro forma revenues of $800 million, global operations, and more than 7,000 employees worldwide. The companies purpose is to lead advancements in drug development through science, service, and shaping solutions.


Scope of the Job:

This position, located in Princeton, NJ reports to the Director or Associate Director. Your basic role is the overall coordination and management of typically one clinical research project with one client, in conjunction with the project team.

You may be responsible for management of multiple protocols, provide monitoring, review and tracking of clinical data and preparation of study specific documents according to FDA regulations and company procedures. You will assist with preparation and presentation of marketing proposals; oversee training of site personnel and project teams as appropriate, including mentoring of Sr. CRAs and Associate Project Managers. You must have demonstrated leadership skills and ability to manage, motivate, and integrate a team.

Qualities should include:

Excellent interpersonal skills and problem solving/decision making skills
Excellent organizational skills
Demonstrated negotiation skills
Excellent oral and written communication skills
Ability to perform all tasks required of Sr. CRA
Experience in clinical trials monitoring
Expert knowledge of FDA guidelines and GCPs
Demonstrated knowledge of budgeting/forecasting
Strong computer skills
Ability to act as liaison with other Divisions necessary to complete the study (i.e., Data Management, Biostats, Medical Writing, Regulatory Compliance, etc.)

Candidate Requirements:

· We seek a professional with a BA/BS in life sciences or Nursing Licensure or other health-related field ( Nursing/Paramedical qualification or Science Degree). M.S. Preferred.

· Requires 4 years experience in clinical research in clinical monitoring/ management combination or program management or clinical auditing or QA/ Regulatory affairs; and minimum of 2 years clinical project management experience or experience handling multiple or global projects in another area of clinical research including 1 year managing a team.

· You must possess excellent oral and written communication skills; ability to develop and lead a project team; people and project management skills; time management/prioritization, resource allocation skills; good customer client relations skills.

· Ability to drive and be available for extensive travel (60% - 80%), including overnight stays.

· You must possess thorough knowledge of ICH-Good Clinical Practice, the Clinical Trial Process, and basic understanding of regulatory requirements gained through previous project management experience.

· Good knowledge of project management techniques and financial control procedures.

· Must have completed 1 –2 studies from site selection to close out.

· For the best fit, you should be a results oriented leader and team player with demonstrated interpersonal and communications skills capable of working collaboratively with colleagues and investigators. You must be able to work and travel independently.

Compensation

A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus, and an attractive benefits package.