Associate Project Manager

The Associate Project Manager (APM) will be responsible for managing the operational and fiscal activities of assigned limited scoped projects while adhering to ICH-GCP, applicable regulations and standard operation procedures. May manage a project team in accordance with company policies and procedures to ensure timely project deliverable within budget. Develop credible relationship with sites, vendors, opinion leaders and clinical investigators.

Responsibilities

  • Assists Clinical Project Manager with management of complex studies and will take a lead role in some aspects of activities related to multi-center trials
  • May manage small trials and project team independently
  • Communicates with the project team (Sponsor, vendors, and multidisciplinary teams)
  • Assists Clinical Project Manager with planning of Sponsor Kick off meeting, Investigator meeting, UAT testing, creating study newsletters, study enrollment/contingency planning and study budget management
  • Acts as Project Manager backup to team meetings (review agenda and minutes) and maintains study timelines with assistance
  • Responsible for preparing/reviewing/maintaining project specific metrics
  • Meet with department team lead to assess plans, processes and/or system requirements are in place to accomplish deliverable per scope of work and timeline
  • Analyze and document project progress and risks developing solutions to enhance efficiencies and mitigate risks to the project and escalate to client, team leads or management as applicable
  • Manage team in accordance with company and sponsor policies, procedures, and relevant SOPs
  • Assist project team in resolving GCP, protocol, and/or SOP issues
  • Ensure lessons learned are considered, shared and improvements included in processes, as applicable.
  • Provide status updates and escalation of key issues to management team
  • Review and approve, travel and expenses for the project team following project budget and company policy
  • Attend meetings as requested including but not limited to bid defenses, Investigator’s Meetings, face to face meeting with Sponsor.
  • Mentor and train project team members

Expectations

  • Demonstrates attention to detail
  • Organizational skills
  • Time management skills
  • Pro-active and displays a professional demeanor
  • Ability to work effectively in an innovative and flexible environment.
  • Good interpersonal skills
  • Ability to work as a team leader and member with cross-functional groups
  • Solid verbal and written communication skills and comfortable with public speaking
  • Ability to handle multiple responsibilities and work well under pressure

Qualifications

  • Bachelor’s Degree from a four-year college or university in Business Administration, Life Sciences, or related field
  • Advanced Degree preferred
  • A minimum of two (2) years in the CRO and/or medical device industry
  • Previous experience in a pharmaceutical, CRO, or medical device company required
  • Sound knowledge of ICH-GCP, local and regional regulations and guidelines for clinical research
  • Knowledge of ISO 9001 preferred
City
Lower Gwynedd
State
PA
Job Type
Full-Time Regular
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