CK Group are recruiting for Local Clinical Trial Manager to join a company in the Pharmaceutical industry on a contract basis for 12 months. This role is remote and can be 4 or 5 days a week.
£44.43 per hour LTD (outside IR35)
Local Clinical Trial Manager Role:
You will collaborate with Functional Manager & Clinical Research Manager for country protocol feasibility and site feasibility assessment. Implement any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommend suitable sites for selection to participate in trial.
Collaborate with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list.
Contribute input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs.
Lead and coordinate local trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
Ensure that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- Minimum of four years of pharmaceutical and/or clinical trial experience is preferred (including site monitoring experience), however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate?s eligibility.
- Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including GCP and local regulatory requirements. Willingness to travel with occasional overnight stay away from home.
- Strong leadership skills. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills
- Strong experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs.
Our client is one of the world\'s leading research-based pharmaceutical companies and is part of a global family of companies.
This Local Clinical Trial Manager role will be based remotely although there may be times you are required to visit site (rarely).
For more information, please contact Julie on 01438 870011 or email firstname.lastname@example.org.
Please quote reference 51139.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Julie Marshall
- Phone: 01438 723 500
- Reference: 51139
Website: CK Group
- Posted: 13th July 2021
- Expires: 10th August 2021