Clinical Project Manager

Location: US East Coast

Contract Type: Full-time/ Permanent

Therapeutic Area: Multiple Indication's (Immunology, Transplantation)

Industry: Biotechnology,

The Opportunity

We are partnering with an innovative and growing biotechnology company focused on advancing treatments within the nephrology space. The organisation is seeking an experienced Clinical Project Manager (CPM) to support the delivery and operational management of its clinical development programmes.

This is an excellent opportunity for a hands-on clinical operations professional who enjoys working within a dynamic biotechnology environment and taking ownership of clinical trial delivery.

Career Progression

Candidates demonstrating strong career progression within clinical research are encouraged to apply.

In particular, professionals who have progressed from Clinical Research Associate (CRA) to Senior Clinical Research Associate (SCRA) and subsequently into Clinical Project Management (CPM/CTM) will be strongly considered.

The organisation is interested in candidates who can demonstrate increasing responsibility across clinical operations, study management and project delivery.

Key Responsibilities:

• Lead and oversee the operational delivery of assigned clinical trials.
• Manage clinical study timelines, milestones, budgets and key deliverables.
• Coordinate cross-functional teams, including Clinical Operations, Medical, Regulatory, Data Management and external vendors.
• Oversee CROs and other external service providers to ensure high-quality study delivery.
• Identify and proactively manage operational risks and issues.
• Support study planning, start-up, execution and close-out activities.
• Ensure studies are conducted in accordance with ICH-GCP, regulatory requirements and company procedures.
• Provide regular study updates and progress reports to internal stakeholders.

Requirements:

• Previous experience as a Clinical Project Manager or Clinical Trial Manager within the pharmaceutical or biotechnology industry.
• Strong evidence of career progression within clinical research and clinical operations.
• Candidates who have progressed from CRA/SCRA into CPM or CTM roles are strongly encouraged to apply.
• Strong experience managing clinical trials from start-up through to close-out.
• Experience working within a small or mid-sized biotechnology environment would be advantageous.
• Exposure to nephrology, renal or related therapeutic areas is preferred.
• Strong CRO and external vendor management experience.
• Excellent stakeholder management and communication skills.
• Ability to work independently and manage multiple priorities within a fast-paced environment.
• Strong knowledge of ICH-GCP and applicable clinical trial regulations.

Location:

Candidates should ideally be based on the US East Coast, with the ability to work effectively with internal teams and external partners.

Application:

This opportunity would suit an experienced Clinical Project Manager, Clinical Trial Manager, or clinical operations professional with a strong track record of career progression who is looking to contribute to clinical development within an innovative biotechnology environment.

Candidates with a CRA/SCRA background who have progressed into clinical project management are particularly encouraged to apply.