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.
- 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
- 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
- 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