POSITION TITLE:
Clinical Project Manager

RESPONSIBILITIES:

The Clinical Project Manager/Senior Clinical Project Manager will have the following responsibilities as assigned by the Associate Director, Clinical Operations:

  • Developing and implementing a detailed project plan, including timeline, budgets, risk management and deliverables in accordance with business and client objectives
  • Continuous monitoring of project plan and status using standard project management tools and reporting to management as necessary
  • Risk management – identifying, logging and managing risks, issues and corrective actions. Should include a section or word on preventative as well
  • Implementing project control tools and interpret data to support critical decisions making appropriate recommendations to team / management
  • Manage the project budget and identify potential scope creep when applicable and as early as possible
  • Developing key study documents in conjunction with other functional area leads assigned to a project and as required in our standard operating procedures (e.g., protocols, model informed consent forms, case report forms, study manuals, etc.)
  • Assist with feasibility analysis and logistics
  • Identifying and evaluating potential investigators and other service vendors to perform clinical study work
  • Facilitating study budget and contract negotiations between a client and investigators (or other service vendors), as applicable
  • Facilitating and tracking payments to investigators (or other service vendors), as applicable
  • Managing interactions with investigators and other vendors to ensure service meets business, regulatory, and client objectives
  • Providing on-site monitoring support for clinical projects, as necessary
  • Ensuring the quality of monitoring services
  • Identifying and resolving issues that jeopardize timely clinical study completion
  • Organizing clinical project/study status information to allow for effective reporting to management and the client
  • Coordinating routine client communications in accordance with contract specifications
  • Developing and implementing departmental Standard Operating Procedures, as necessary
  • Lead and assist with corporate and departmental initiatives as assigned by the Associate Director of Clinical Operations
  • Maintain a positive, progressive, and proactive management style and communications
  • Quality check each deliverable prior to sending to internal or external clients
  • Performing other duties as required

REQUISITE SKILLS:

  • Excellent written and oral communication skills, including good presentation skills
  • Excellent organizational skills with ability to multi-task
  • Demonstrated ability to effectively manage clinical studies/projects with limited supervision
  • Demonstrated ability to accurately identify and resolve problems
  • Demonstrated ability to work effectively with representatives from a broad range of scientific disciplines
  • Solid understanding of the drug development process
  • Working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice and ICH
  • Demonstrated expertise with PCs and standard Microsoft Office software applications
  • Familiarity with formal concepts of project management and planning a definite plus

EDUCATION/EXPERIENCE:

  • Minimum of a Bachelor’s degree in a scientific discipline. Candidates with a BA or RN with appropriate experience will also be considered
  • Minimum of five years experience in the pharmaceutical or biotechnology industry is required
  • Candidates should have prior experience as a Clinical Research Associate. Furthermore, candidates must be able to demonstrate a history of assuming the lead supervisory role for clinical projects

PHYSICAL REQUIREMENTS:

Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity, flexibility, steadiness or reaction time.

From time to time as required by the job, the incumbent may be required to travel via an appropriate means to reach the target destination in a timely manner (e.g., automobile, airplane, train, etc.) and, therefore, must not be adverse to the potential physical and personal stresses associated with this travel.

How To Apply

To apply for a position, please send cover letter and resume to .