Clinical Scientist / Clinical Scientific Associate Director

Proclinical is working with a top 10 global pharmaceutical company that is seeking to hire a Clinical Scientist to join their R&D team. This role will be accountable for all aspects of the management and clinical execution of assigned non-drug and biomarker studies within Translational Medicine. The Clinical Scientist leads the planning and implementation of all operational aspects of these trials from study concept to reporting according to timelines, budget, operational and quality standards.

Job Responsibilities:

• Clinical Scientist for early phase research, non-drug, and biomarker clinical studies including multi-country / multi-centre trials.
• Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) to ensure all trial deliverables are met. 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, TA Heads and project team members.
• Lead 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 investigator meetings, or site initiation meetings (as applicable).
• Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations and maintaining awareness of issues raised.
• Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents as applicable. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects' eligibility.
• In collaboration with the Research Lead, Medical Expert, and CTT, manage the ongoing medical/ scientific review of the clinical study data, and coordinate the data analysis and interpretation for first interpretable results. Oversee the data review and interactions with the Data Manager, Statistician, and third parties (as applicable) to ensure high quality data are transferred/available in a timely manner.
• Responsible for the Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements.
• Responsible for the set-up and maintenance of the Trial Master File (TMF) for studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.
• Contribute to the evaluation of clinical sites and external service providers performing TM studies in healthy volunteers and patients.
• Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved and address corrective actions.
• Oversee the work of assigned support Clinical Trial Associates(s), ensuring clear delegation /assignment of duties are documented.
• Act as a mentor to support the training and on-boarding of new CS&I associates.
• Provide advice to other departments and line functions and to cross-functional working groups as required. Function as a Subject Matter Expert as assigned.
• Identify areas for process or technology improvements.
• Responsible for following best practices and standards for trial management within TM; expected to share lessons learned.
• Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of company SOPs and internal policies. Assist or perform training for CTA and Clinical Scientists.

Skills and Requirements:

• PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences.
• Business-level oral and written English
• Relevant and demonstrable experience in clinical research / bio-banking / biomarker development and non-drug studies. Preferably, also experience in clinical trials in healthy volunteers and patients.
• Good knowledge of Good Clinical Practice.
• Track record of successfully managing multiple early phase clinical research studies / projects and/or clinical trials concurrently (or equivalent).
• Office and clinical trial software IT computer literacy and good overall awareness of modern information technology.
• Operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
• Clear written and verbal expression of ideas, an active/proactive communicator.
• Well-developed interpersonal skills, with a proven track record of successfully interacting with and influencing of a wide range of people, building strong positive relationships.
• Customer orientation awareness and focus.
• Used to working independently and in a team environment, being flexible and adapting in a changing environment.

To Apply:

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 call Weronika Ficek on +44 203 0789 550 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.