Job Title: Clinical Trial Leader
Responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). Functions as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards.
- Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country / multi-centre trials. The focus will be dependent on department workload and need).
- Responsible for leading and matrix managing the multidisciplinary CTT and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices
CTL role will involve the following tasks.
- Author of the clinical study protocol and other study essential documents.
- Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.
- In collaboration with outsourcing/planning/feasibility personnel, CTT, Local CPO representatives and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and/or Site Initiation meeting(s).
- Train and support the CRA(s)/CRO(s) on study protocol and related questions, and serve as point of contact for managing/answering questions relating to trial procedures and subjects? eligibility.
- Ensure the set-up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.
- Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget, and quality standards. Communicate study progress to CTT, CS&I Management, CS&I TA Head and Project team representatives and others (as appropriate).
- Regularly update all trial information databases to manage accuracy of information.
- Review and approve all study payments as per financial agreements.
BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD or equivalent qualification or work experience.
Fluent written and oral English
- Relevant experience (5 years) in clinical trial management (e.g., study management in a multinational environment using different models for trial execution).
- Demonstrated leadership and problem-solving skills.
- Track record of managing multiple, complex clinical trials.
- Capable of clear written and verbal expression of ideas, an active/proactive communicator.
- Ability to interact with a wide range of people and build strong, positive relationships.
- Potential for customer orientation awareness and focus.
- Computer literacy.
- Excellent organizational skills and interpersonal skills.
- Ability to work independently and in a team, environment managing multiple priorities.
For more Information, please call Fandi Hatib on +44 1727 817600 or email firstname.lastname@example.org
- Agency: Achieva Group Limited
- Reference: FH-30
Website: Achieva Group Limited
- Posted: 31st August 2022
- Expires: 28th September 2022