Clinical Trial Leader

Hobson Prior are seeking a Clinical Trial Leader to join a biotech organisation who are focusing on transforming immunological insights into life-saving therapies. As the Clinical Trial Leader, you will lead the planning, implementation and execution of the organisation's Clinical Trial to meet corporate and clinical research goals.

Job Responsibilities:

• Lead clinical and operational activities across various functions to plan, implement and execute clinical program.
• Accountable for CRO management and oversight; ensure timelines and budget are met to achieve corporate milestones.
• To act as the primary contact for vendors and help manage relations to third party providers.
• Approve and track invoices received for all clinical activities.
• Proactively anticipate possible issues impacting the clinical trial conduct and help the organisation to address them appropriately.
• Manage central the organisations TMF system.
• Monitor and review clinical data for integrity and completeness in ongoing studies.
• With CRO, ensure all documents are delivered on time to meet submission targets to Health
• Authorities and ECs.
• Oversee and manage drug supply logistics in collaboration with CMC to ensure adequate availability of drug material on site and compliant shipment is documented to cover all clinical activities.
• Support preparation of clinical study documents ensuring accuracy and completeness; review protocol, informed consents, study documents and ensure GCP compliance.
• Lead the development of clinical study reports, as needed.

Key Skills:

• Well-developed interpersonal skills.
• A track record of collaborating with and influencing a wide range of people, and of building positive relationships.
• Flexible mindset to thrive in a fast-paced start-up environment.
• Eager to proactively learn, tackle issues and take accountability.
• Excellent oral communication and writing skills in English.
• Clear written and verbal expression of ideas; an active communicator

Requirements:

• MSc in life sciences or other equivalent degree in medical/biological sciences.
• At least 3 or more years' experience within pharma clinical trial management/operations, coupled with a good knowledge of the drug development field.
• Thorough knowledge of GLP, GCP and ICH guidelines.
• Project management and budget management experience.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.