Clinical Trial Leader
Posted on Apr 14, 2022 by Michael Bailey Associates - UK Contracts
A pharmaceutical company is searching for a 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 (ICH/GCP/clients SOPs and procedures).
1. Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country/multi-center trials. The main focus will be de- pendent on department workload and need).
2. 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).
> Much more included!
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
1. Relevant experience (5+ years) in clinical trial management (eg study management in a multi- national environment using different models for trial execution).
2. Demonstrated leadership and problem-solving skills.
3. Track record of managing multiple, complex clin- ical trials.
4. Capable of clear written and verbal expression of ideas, an active/proactive communicator.
5. Ability to interact with a wide range of people and build strong positive relationships.
6. Potential for customer orientation awareness and focus.
7. Computer literacy.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.