Senior Scientist, Clinical Operations

Senior Scientist, Clinical Operations

09 Oct 2024
Pennsylvania, Northwales, 19454 Northwales USA

Senior Scientist, Clinical Operations

Serve as the lead clinical scientist on the clinical trial team. Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the Clinical Director. Collaborate cross-functionally in the development of the study protocol and related study materials (e.g., ICF documents / amendments). Partner with the Study Manager on study deliverables. Ensure CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming. Collaborate cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct. Provide tactical/scientific mentorship to other clinical scientists. Must have a Bachelor's degree (or US equivalent) in Life Sciences plus 5 years relevant experience in pharmaceutical and/or clinical drug development or a Master's degree (or US equivalent) in Life Sciences plus 3 years relevant experience in pharmaceutical and/or clinical drug development. Must possess solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH); ability to manage multiple competing priorities with good planning, time management and prioritization skills; and strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions. Ability to interact with key stakeholders across department, division, and company; ability to provide a proactive approach, strategic thinking and leadership in driving toward study goals; and ability to influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division required. Must be able to apply leadership skills to processes, leading meetings, and influencing peers in a matrix environment. Must possess problem solving, prioritization, conflict resolution, and critical thinking skills; team building capabilities through proactive coaching; and strong communication, technical writing, and presentation skills. Telecommuting permitted. To apply, visit Merck Sharp & Dohme LLC's career site at www.merck.com/careers to create a profile and submit your CV for Job Req# R314381. EOE. Merck Sharp & Dohme LLC is a subsidiary of Merck & Co., Inc.

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