Our leading pharmacutical compamy cliemnt is looking to hire a Clinical Trial Leader on an 18 months contract.
Responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). Functions as a 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/Novartis 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 dependent on department workload and need.
2. Responsible for leading and matrix managing the multidisciplinary CTT and support functions as assigned to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices CTL role may involve some or all 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 CO 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. ? Oversee Trial Master File for assigned studies
Education: BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD or equivalent qualification or work experience.
Languages: Fluent written and oral English
1. Relevant experience (5 years +) in clinical trial management (e.g. 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 clinical 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.
8. Excellent organizational skills and interpersonal skills.
9. Ability to work independently and in a team environment managing multiple priorities.
- Agency: Achieva Group Limited
- Reference: BH-33916
Website: Achieva Group Limited
- Posted: 18th November 2022
- Expires: 16th December 2022