Senior Clinical Project Manager – Maternity Cover (September start) / 6-Month Contract - Remote

Are you an experienced Clinical Project Manager interested in joining our biotech client? Our client is seeking a highly motivated Senior Clinical Project Manager to join their Clinical Operations team and support the operational management and execution of clinical trials.

Responsibilities

1. Autonomously lead one or more complex/pivotal clinical studies, providing leadership, operational strategy, and direction to cross-functional clinical study team members (in-house and outsourced) from concept to closeout.
2. Work closely with the Clinical Programme Lead (CPL) and Principal CPM to implement operational strategies for optimal study delivery.
3. Mentor junior CPMs and Clinical Project Associates (CPAs).
4. Contribute to the optimization of Clinical Operations processes and continuous improvement activities.
5. Manage study timelines, budgets, and quality targets, ensuring effective tracking and forecasting.
6. Collaborate with Site Management and Engagement on country/site selection and recruitment strategies.

Required Experience

1. 10+ years of clinical research experience, including 5+ years in clinical project management or equivalent roles.
2. Experience managing full-service outsourced projects.
3. Experience in hematology/oncology and/or autoimmune phase I/II studies.
4. Experience with ATIMPs, site-level management, and managing pivotal trials is advantageous.

Skills and Knowledge

1. Adept at working in a global setting and matrix environment.
2. Broad experience in Clinical Trial Execution disciplines (e.g., senior study management, data management, clinical leadership).
3. Demonstrated project management and leadership skills.
4. Understanding of key drivers impacting budgets and managing projects within budget.
5. Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel, and service providers.
6. Ability to operate in complex and challenging environments.
7. Thorough knowledge of ICH-GCP guidelines and FDA regulations.
8. Knowledge of medical terminology and clinical patient management.
9. Ability to travel internationally (20-30%).

This role offers an exciting opportunity to be part of an innovative biotech company. If you're a passionate Senior Clinical Project Manager eager to make a difference, we’d love to hear from you! Reach out on LinkedIn or send your CV to.