Project Manager

5/12/2019
PROJECT MANAGER -- IMMEDIATE OPENING

SEEKING LOCAL CANDIDATE TO FILL OPENING FOR PROJECT MANAGER The Project Manager is responsible for the overall project management from project kick-off through clinical study report completion and FDA submission, ensuring that the project objectives have been met. The Project Manager is also responsible for review and comment on company-wide and department-specific SOP, resource monitoring, and promotion of SOP compliance. 


Responsibilities:

  • Participate in the periodic review and revision of departmental policies and SOPs
  • Collaborate interdepartmentally on the proposal development process.
  • Participate in bid defense presentations and meetings.
  • Direct the conduct of assigned projects and activities associated with the project.
  • Ensure compliance with FDA regulations, ICH/GCP, and SOPs for projects filed under a U.S. IND, IDE or other FDA requirements.
  • Manage resource and financial aspects of the clinical study.
  • Communicate effectively with internal and external members of senior management, the project team, investigators and site personnel, and expert physicians.
  • Manage problem identification and resolution in order to adhere to the project time lines and budget.
  • Assume certain duties of CRA or other team members in order to meet project goals.
  • Lead the development, implementation and review of the Project Plan.
  • Assist with IND and NDA coordination and preparation.
  • Develop a working knowledge of assigned protocols.
  • Design, write, and review draft protocols, draft CRF, informed consent, operations manual and other documentation required for conduct of a project.
  • Resolve issues regarding grant negotiations, budgets and contracts with investigational sites.
  • Review Clinical Research Associate visit reports to assure report adequacy and adherence to project-specific monitoring plans, applicable SOPs and FDA regulations and guidelines.
  • Supervise the planning and facilitation of investigator meetings.
  • Review recruitment strategy for meeting target enrollment of clinical protocols against target project goals.
  • Review and comment on draft analysis outputs (tables, listings, and graphs) to be incorporated into Final Study Reports (FSR), integrated summaries and NDAs.
  • Write drafts and/or review appropriate sections of the FSR.
  • Participate in interactions/meetings with regulatory authorities, as needed.
  • Work with Data Management staff to review case report data in-house, and interface with study personnel to resolve data queries
  • Recommend outsourcing when appropriate and interact with appropriate project team members to ensure that outsourcing to CROs/vendors will meet expected performance standards for quality, timeliness and budget.
  • Co-monitoring and auditing, as needed.

Qualifications:

  • BA/BS in nursing, biological sciences or related field.
  • Five years of clinical research experience with a CRO, pharmaceutical or biotech firm.
  • Progressively increasing clinical research experience which includes project management, staff supervision and/or monitoring experience.
  • Extensive knowledge of clinical trial management and FDA regulatory requirements.
  • Working knowledge of Good Clinical Practices (GCPs).
  • Strong oral /written communication and negotiation skills.
  • Strong interpersonal and leadership skills and abilities.
  • Detail-oriented with strong planning, organizing and follow-through skills.
  • Proficient in Microsoft Office software.
  • Ability to work effectively both independently and in a team environment.


Job Type : Full-Time
Education Level : Bachelors Degree
Experience Level : ""
Job Function : ""
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