Senior Scientist, Clinical Operations
MSDAbout the role
Job Description
Responsibilities:
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.
Educationa & Skills requirements:
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.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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