Serve as key client contact for assigned project responsibilities, establishing working relationships with client project teams which result in client satisfaction, operational excellence and increase potential for repeat business.
- Lead core project team(s) and facilitate team's ability to lead extended project team(s), ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.
- Serve as escalation point for project issues, within area of project responsibility, to internal and external stakeholders, as appropriate and resolve conflicts as needed.
- Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s).
- Monitor project scope, schedule and costs to ensure all remain on track with the contract and with financial performance targets. Initiate and implement appropriate actions to proactively manage the change control process both internally and externally.
- Proactively lead quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Covance and client requirements.
- Create and manage variance to required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary. Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member’s respective supervisors.
- Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract.
- Define and manage project resource needs and establish succession plans for key resources.
- University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- Masters or other advanced degree.
- PMP certification.
Minimum Qualifications Required:
- 1 + years of current experience working as a Project Manager at a CRO managing full-service global trials/studies and the responsibility of the financial management of the studies.
Minimum Experience Required:
- Minimum of five (5) years relevant clinical research experience in a pharmaceutical, medical device and/or diagnostic company/CRO.
- In lieu of the above requirement, candidates with (a) six (6) years supervisory experience in a heath care setting and (b) five (5) years clinical research experience including one (1) years of project management experience (clinical trial management experience preferred) in the pharmaceutical, medical device and/or diagnostic or CRO industries will be considered.
- Good understanding of clinical research terminology.
- Working knowledge of ICH - GCP/ISO 14155 including regulatory requirements for the conduct of clinical research.
- Broad knowledge of drug or medical device and diagnostic development process and client needs.
- Working knowledge of project management processes.
- Experience managing projects in a virtual environment.
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
- Financial awareness and ability to actively utilize financial tracking systems.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
- Excellent communication, planning and organizational skills.
- Ability to work independently.
- Ability to negotiate and liaise with clients in a professional manner.
- Ability to present to staff at all levels.
- Good computer skills with good working knowledge of a range of computer programs (i.e., Microsoft Word, Excel, Project, Outlook).
- Device and/or Diagnostic Experience.
- Cardiovascular Therapeutic Area Experience.