.Location: Barcelona, SpainJob reference: R-212468Date posted: 11/06/2024Position: Clinical Scientist, Clinical Development R & DLocation: Hybrid office 3 days per week, BarcelonaReports To: Senior Director, Clinical Operations Therapy Area HeadThis is what you will do:The Clinical Scientist is part of a cross-functional team in the design and execution of a clinical study and may provide input into the global clinical development plans and strategy for a therapeutic area.
The job holder supports assigned clinical development physician(s) and scientists with deliverables necessary for effective and efficient clinical development plan design and execution and therapeutic area strategy.You will be responsible for:Assisting the clinical development physician assigned to the study(ies) in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents (may manage several studies in parallel).Assisting in the implementation of protocols and interactions with vendors and CROs, engaging with relevant internal and external stakeholders; key member of the clinical study team.Supporting review of clinical data to identify and evaluate study data trends, outliers, protocol violators, etc., and write any necessary queries to be communicated to sites to ensure data accuracy and completeness of the assigned study.Participating in safety review meetings regarding potential safety events within a given clinical study or across the assigned clinical program.Supporting preparation of abstracts, publications, and poster presentations of the clinical study findings and results throughout the life cycle of the assigned study or product as applicable.Supporting medical affairs activities, payer and reimbursement activities.Supporting Data Management in the build of the CRF and all associated instructions plans (e.G., CRF completion instructions and Data Review Plan).You will need to have:General knowledge in the principles of clinical research methodology (i.E., medical monitoring), statistics, data analysis, and interpretation.
A plus to have detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.Familiarity with scientific literature searches.Ability to clearly communicate in English to internal and external stakeholders orally and in writing.Basics of strategic vs. tactical thinking.Ability to grow and maintain a high level of expertise in the therapeutic area assigned.The duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation, to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours