- Lead core project team during study start up phase and facilitate team’s ability to lead extended/complete project team. Depending on size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and/or Project Director.
- Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services.
- Resolve conflicts as needed.
- Monitor project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations.
- Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Covance and client requirements.
- Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs.
- Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects.
- Prepare and actively participate as operational lead in internal Project Review meetings. Depending on size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and/or Project Director.
- Provide performance feedback of team members to respective supervisors.
- Present at external and/or internal meetings.
- Define and manage project resource needs and establish succession plans for key resources.
- Create required project plans. Implement and monitor progress against project plans and revise as necessary.
- Responsible for appropriate issue escalation to CAIR program and/or appropriate stakeholder(s).
- Serve as key client contact for assigned project(s).
- Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
- Prepare and deliver presentations in collaboration with relevant departments for new business as required.
- Meet financial performance targets for assigned project(s).
- May have line management responsibilities for the training, utilisation, development and performance review of assigned staff.
- Manage client project metrics.
- Perform other duties as assigned by management.
- 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.
- Detailed knowledge of financial control procedures (i.e. costing systems, time reporting).
- Working knowledge of project management processes, especially concerning study start up.
- Working knowledge of time and cost estimate development.
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Broad knowledge of drug development process and client needs.
- Masters or other advanced degree.
- PMP certification.
- Working knowledge of Covance and the overall structure of the organization.
- Basic knowledge of Covance sales and business development strategies and procedures.
- Working knowledge of Covance SOPs.
- Minimum of five (5) years relevant clinical research experience including demonstrated skills and competency in clinical project management tasks, especially regarding study start up.
- In lieu of the above requirements, candidates with >five (5) years supervisory experience in a heath care setting and five (5) years clinical research experience with at least one (1) year project management experience in the pharmaceutical or CRO industries will be considered.
- Experience in 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.
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