Clinical Trial Leader II
A job vacancy for a Clinical Trial Leader II has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.
- Functioning as Clinical Trial Leader for assigned phase I/II studies (scientific and/or operational complexity) including multi-country/multi-centre trials. The main focus will be dependent on department workload and need).
- 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.
- Communicating study progress to CTT, CS&I Management, TA Heads, and project team members.
- Authoring the clinical study protocol, amendments, and related documents, such as Informed Consent Form, monitoring plans, and other study essential documents.
- Ordering and managing clinical trial materials, including drug supplies and CRFs.
- Leading all aspects of study planning and in collaboration with outsourcing/ feasibility personnel, CTT members, Local Country Office representatives and CRAs, identifying sites and manage study set-up, including responsibility for organising 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 serving 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.
- Chairing CTT meetings, managing team actions, and actively tracking study progress to ensure completion according to specified timelines, budget, and quality standards.
- Communicating study progress to CTT, CS&I Management, CS&I TA Head, and Project team representatives and others (as appropriate).
- Regularly updating all trial information databases in order to manage accuracy of information.
- Reviewing and approving all study payments as per financial agreements.
- Interacting 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.
- Assisting in data review and interactions with the Data Manager, Statistician, and third parties (e.g. outsourced data management or data vendors) to ensure high quality data are transferred/available in a timely manner.
- Writing up reports 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
- Publishing reports.
- Coordinating the ongoing medical/scientific review of the clinical trial data (as needed) coordinate the data analysis and interpretation including the development of first interpretable results.
- Ensuring a complete review is conducted of all study documentation within the assigned studies/project at the end of each study, with all essential documents appropriately archived and paper Trial Master Files physically transferred to the central archive.
- Coordinating pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved and address corrective actions.
- Overseeing the work of assigned support CTL/CTA(s), ensuring clear delegation / assignment of duties are documented.
- Contributing to the identification and evaluation of clinical sites and external service providers as appropriate for assigned studies.
- Providing advice to other departments and line functions and to cross-functional working groups as required as applicable to assigned studies.
Skills and Requirements:
- BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD or equivalent qualification or work experience.
- At least 5 years relevant experience in clinical trials / drug development (e.g. study management in a multinational environment using different models for trial execution).
- Track record of successfully managing multiple, concurrent phase I and II complex clinical trials.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Lewis Davis at +44 203 871 8095 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.