Clinical Project Manager

Location: Flemington, NJ

Travel: 0-25%

Therapeutic area of expertise: Oncology

Overview:

Assume overall responsibility for successful conduct of clinical projects through effective direction of the Project Team. Establish objectives and strategies to direct activities, evaluate capabilities, and track, measure, and report the status of project milestones. Work closely with client team members to ensure timely and accurate reporting of critical information. Function as primary contact for project issues, including the planning of deliverables and the managing of budgets. Identify critical project tasks/issues and recommend course(s) of action to expedite project objectives. Conduct regular Project Team Meetings including distributing Action Items with assignments and due dates. Travel locally and nationwide as needed.

A. Essential Functions:

1. Project Management Activities
• Act as the primary client contact regarding project issues including, but not limited to, planning deliverables and managing budgets.
• Act as primary liaison between client and Beardsworth clinical staff to ensure appropriate protocol-specific deliverables.
• Prepare and update project plans based on contractual obligations regarding the scope of work, timelines, and finances.
• Identify critical project tasks/issues and recommend courses of action to expedite the project objectives.
• Prepare and distribute periodic project progress reports and oversee preparation of client correspondence.
2. Organizational Management Activities
• Identify Changes-in-Scope of the activities and advise on whether to issue an Amendment to reflect these change(s).
• Critically review business proposals for pharmaceutical clinical trial opportunities, when necessary.
• Direct and oversee project-specific initiation and orientation, as necessary, particularly through facilitation of effective kickoff meeting and participation in investigator meetings.
• Conduct regular Project Team meetings and prepare and distribute minutes in the form of Action Items with assignments and due dates. Oversee and coordinate activities of Team members.
• Coordinate, based on project progress, recommendations to appropriate line managers in all other disciplines.
• Ensure the set-up, maintenance, and close-out of project files (eg, regulatory documents transmitted and filed).
3. Financial Activities
• Review and update revenue projections based upon project plan and proposal fees.
• Trigger invoicing process for investigator payments, pass-through work and/or Milestone payments.

B. Non-Essential Functions:

• Assist in Business Development activities such as identifying potential projects with current clients plus identifying possible new clients.
• Participate in business proposal generation and final review process.
• Participate in capability presentations, as needed.

C. Skills Required:

• Keeps current with information on Pharmaceutical R&D and therapeutic area developments.
• Ability to be a Leader and to mentor staff.
• Strong analytical skills.
• Strong written and verbal communication skills.
• Ability to work in a fast-paced environment with changing priorities.
• Monitoring of some study sites may be required; ability to travel both locally and nationwide as needed.
• Function effectively and efficiently as a "Team-Player"
• Ability to deliver satisfaction to the clients (large pharmaceutical companies and emerging biotech firms) by ensuring work is done on of before timeline and within budget, while working to ensure "partnership" with client along the way.

D. Education/Work Experience:

• B.S. degree in nursing, pharmacy, or related health field, or experienced in healthcare; advanced degree preferred.
• Minimum of 5 years related experience from the pharmaceutical industry or a CRO along with management expertise including a history of supervising direct reports.
• Thorough knowledge of the pharmaceutical clinical drug development process and team-based matrix management.
• Thorough knowledge of Good Clinical Practices (GCPs)

 

Please contact or fax your CV, with salary requirements and contact information to (908) 788-5281, ATTN: Human Resources.