Interim Clinical Science Manager Job Role:
The Interim Clinical Science Manager will work closely with the OPUK Study Team, Project Team, external Service Providers (SPs) and external consultants throughout the clinical study lifecycle. The CSM will establish a clinical study protocol(s) consistent with the clinical development plan and will ensure the quality and integrity of the study data, ensure appropriate risk assessment and management is performed and ensure appropriate analysis and reporting of the study data.
− Under the direction of CSD, the Interim Clinical Science Manager will support the CSD’s activities on the science and strategic planning for the project.
Key responsibilities shall include but are not limited to:
At the study level, in close liaison with the OPUK Clinical Operations Manager (COM) and under the guidance of CSD, the CSM is responsible for all appropriate clinical science aspects of the study. These responsibilities shall include but are not limited to;
− Responsibility for ensuring the quality of all clinical science aspects of the trial, e.g., including but not limited to, clinical protocol development and clinical science data review and clinical study report development.
− Responsibility for developing and maintaining study documents related to clinical science aspects of the trial, e.g., including but not limited to, a clinical study protocol, clinical study report, investigator brochure, clinical IMPD, data review charter, and clinical science review plan.
− Providing input to other study documents, e.g., including but not limited to, study management oversight plan, RFPs, contracts, statistical analysis plan, data management plan, CRF.
− Responsibility for the clinical science review of trial data, e.g., including but not limited to, demographic, efficacy and safety data, protocol violations (specifically to ensure correct number of subjects are evaluable for protocol objectives), detection of data trends and safety signals and to ensure adherence to protocol so that study objectives are met. The CSM will liaise with appropriate internal and external functions to conduct the review and will report the results of the ongoing science review regularly to the study team.
− Managing SPs/contractors and overseeing their performance and quality of work to ensure they meet an agreed project plan, contracts and any study specific requirements related to any clinical science aspects of the trial.
− In liaison with the Clinical Pharmacology Manager, actively contribute to the oversight of the pharmacokinetic data production and analysis (including but not limited to the oversight of any external SPs/contractors sample analysis plan, statistical analysis plan).
− In liaison with the COM, actively contributing to study meetings / training
Education, Experience, Knowledge, Skills and Abilities
− Minimum BSc in the life sciences, nursing degree, or equivalent combination of education and experience. A higher degree (Masters, PhD) is preferred.
− Significant demonstrable experience in the scientific aspects of clinical development gained within a contract research organisation (CRO), pharmaceutical, or biotechnology company.
− Thorough knowledge of regulatory requirements, clinical development, and clinical study procedures.
− Demonstrated proficiency with ICH/GCP guidelines.
− Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
− Able to interact effectively at all levels within the organisation, as well as with external partners and clients.
− Proven ability for working independently with minimal supervision. A can-do attitude with a willingness to get actively involved.
− Must be diplomatic and tactful in liaising with staff and management.
− Must be meticulous and methodical, with the ability to review both data and procedures in detail and the ability to see the greater overall picture.
− Experience working in a team environment under time and resource pressures.
− Good negotiation skills
− Strong written and spoken English
− Excellent communication skills (verbal and written), organisation, presentation and time management skills
− Proficient computer skills in Word, Excel, PowerPoint, email and Internet.
By clicking “apply” you will be sending your CV to Ryan Jordan at Barrington James. Ryan is a Specialist Medical Recruiter years recruitment experience. Ryan will discuss the opportunity in detail with you facilitate your application and will manage the process acting as a link between the company and yourself. He will assist in all elements of the process, facilitate the offer process, keep in contact throughout your notice period and even catch up with you during your first week in your new role as Vice President, Clinical Development.
This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply without delay as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to “Rjordan” (at) barringtonjames (dot) com alongside a copy of your CV.