The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations e.g. Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) in the performance of their role.
Essential Job Duties:
Operational delivery
- Accountable for project delivery with regards to agreed time, scope, cost and quality
- TEAM COMMUNICATION: Serve as key client contact for assigned projects, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby 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. Depending on size and scope of project(s), this job duty may be performed in collaboration with a Project Director
- Serve as escalation point for project issues to internal and external stakeholders, as appropriate
- TEAM COMMUNICATION: Proactively identify and resolve conflicts as needed
- COST: Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s)
- SCOPE: Deliver project(s) to scope, schedule and costs, ensuring 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
- RISK: Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Covance and client requirements
- QUALITY: 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
Business Development
- In collaboration with relevant departments, prepare and deliver presentations for new business as required
- Perform other duties as assigned by management
Line Management & Talent Development
- Trains & mentors PM Academy PCs in multiple areas of expertise
- May be responsible for Line Management and Talent Development
- Ensures allocated resources are aligned with current and forecasted work in terms of capability, quantity, timing, and efficiency
- May be responsible for on-boarding, development and retention of high performing talent; strengthening and deepening talent bench and succession
- Assesses project management competencies for assigned staff in order to create developmental plans that will increase competencies and close performance gaps
- Provides line management and technical support to assigned project leaders, including training, development and performance review of assigned staff
Experience
Minimum Required:
- Minimum of seven (7) years of relevant clinical research experience in a pharmaceutical company/CRO, including at least two (2) years of full project management responsibility
On the Job Experience:
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)
- Experience managing projects in a matrix and virtual environment
- Excellent communication, planning and organizational skills
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
- Financial awareness and ability to actively utilize financial tracking systems
- Good knowledge of project management processes
- Ability to work independently and mentor junior project team members
- Ability to negotiate and liaise with clients in a professional manner
- Ability to present to staff at all levels
Education/Qualifications
Required:
- 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
Preferred:
- Master or other advanced degree
- PMP certification
