Clinical Trial Leader
Jocelyn Blackham is recruiting for a Clinical Trial Leader to join a global pharmaceutical company based at their site in Basel on a contract basis for 18 months.
The successful candidate will be responsible for:
- Management and clinical execution of assigned clinical trials within Translational Medicine (TM).
- 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).
- Acting as Clinical Trial Leader for assigned phase I/II studies (scientific and/or operational complexity) including multi-country/multi-center trials.
Leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and supporting functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices. Communicate study progress to CTT, CS&I Management, TA Heads and project team members.
Interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.
- Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing/narrative group to ensure report is completed according to current requirement.
Further responsibilities will include:
- Authoring of the clinical study protocol, amendments and related documents. Informed Consent Form, monitoring plan and other study essential documents.
- Leading all aspects of study planning and in collaboration with outsourcing/feasibility personnel, CTT members, Local Country Office 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).
- Training and supporting 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.
- Ensuring 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.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD or equivalent qualification or work experience.
- Fluent in written and spoken English.
- Experience working within the respiratory area is essential.
- Relevant experience in clinical trials/drug development (e.g. study management in a multinational environment using different models for trial execution).
- Demonstrated leadership and problem-solving skills.
This is an excellent opportunity to join a leading pharmaceutical environment.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email firstname.lastname@example.org. Please could you send any correspondence in English. Please quote reference 47068 in all correspondence.