Joining a well-established yet expanding team fully outsourced to one of our global pharmaceutical clients, the Senior Clinical Project Manager ensures overall successful execution of phase 1-4 clinical trials in Oncology, in accordance with applicable Standard Operating Procedures, agreed timelines, budgetary and regulatory requirements, on either a global or regional scale.
The Senior Clinical Project Manager serves as the leader for the Study Management Team, with ultimate responsibility for the set-up, planning and coordination of clinical trials through to study closure. Managing and tracking key study metrics to ensure adherence to project milestones, along with communicating with other departments, will form a key part of this role.
Other fundamental tasks include driving activity to ensure that enrolment commitments are met, whilst also checking that relevant documentation is duly updated, resolving problems, proactively managing risk and (where necessary) timely escalating issues. Clearly, the Senior Clinical Project Manager will also work in accordance with applicable health authority regulations and internal standard operating procedures. Where necessary, participation in the preparation for and conduct of Health Authority inspections and internal audits will also feature in this role.
Working at the very heart of the clinical trial, you will deliver appropriate training to your study team on a trial-specific basis. Additionally, you will act as a key liaison with Quality Management in order to establish a high level of quality throughout the project lifecycle.
Education & Credentials
Bachelor’s degree in a relevant scientific discipline
- Minimum of seven years of relevant clinical trialexperience in the pharmaceutical or biotech industry with at least two of those years managing clinical trial activities - Highly preferred
Knowledge, Skills and Abilities
- Thorough and integrated knowledge of the clinical trial process including cross-functional handoffs and dependencies
- Advanced skills and through knowledge in regard to all clinical operations and site management activities
- Advanced skills in Project Management, particularly in regard to management of schedule, budget, communication, resources and quality
- Ability to influence without authority
- Strong communication, and negotiation skills
- Strong leadership skills including the ability to create a sense of clear direction
- Experience in oncology
- Experience in global trials
Ability to travel to meetings, sites and vendors approximately 10-20%
Oncology experience highly preferred