Clinical Trial Manager

Hobson Prior are looking for a Clinical Trial Manager to join an exciting pharmaceutical organisation who are focused on delivering innovative, transformational medicines with optimized pharmacology and pharmacokinetics to patients all over the world.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Leads the clinical operations team (CRAs and CTAs) and cross-functional clinical trial team in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines.
• Accountable for clinical trial material (CTM) label review and approval and assisting with CTM forecasting.
• Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues appropriately in a timely manner.
• Obtain and relay key study issues, status updates and other study information to the clinical trial team and management.
• Manages recruitment efforts and activities to meet study enrolment goals and timelines and provides status to upper management.
• Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities.
• Provides input on the development of eCRF design.
• Partakes in IRT, EDC and ePRO user acceptance testing.
• Partakes in data cleaning, listing, and report output reviews.
• Any other assigned duties.

Requirements:

• Bachelor's degree.
• 6+ years of relevant and progressive clinical trial management experience.
• Experience in full-cycle drug development.
• Strong understanding of clinical trials processes, protocols and medical terminology.
• Strong experience utilizing CTMS, EDC, TMS and related software.
• Prior experience in management and monitoring of CRO and investigative sites.
• Strong experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management.
• Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations.
• Advanced experience with bio-samples, storage of 3rd party data.
• Motivated to work in a fast-paced, high accountability environment.
• Experience in Ulcerative Colitis / Gastrointestinal / Crohns .
• Travel up to 25%.

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.