Clinical Operations Scientist managing clinical studies and supporting protocol development for pharmaceutical company. Ensuring trial quality and stakeholder interaction in a hybrid work environment.
Responsibilities
Responsible for specific clinical/scientific activities on a single study or across multi e studies
Support development of Protocol and related study materials (e.g., ICF documents/amendments, data management deliverables)
May interact with internal and external stakeholders (e.g., country operations, committees, vendors) in support of clinical study objectives
Support development of site and CRA training materials
Prepare clinical narratives
Collaborate cross-functionally to monitor clinical study data to ensure quality, completeness, and integrity of trial conduct.
Participate in CRF design to ensures data collection is in alignment with the protocol.
Requirements
Bachelor's Degree +2 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +1 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
Degree in life sciences, preferred.
Working knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
Ability to manage multi e competing priorities with good planning, time management and prioritization skills
Analytical skills with the ability to interpret clinical trial data and synthesize conclusions
Interact with key stakeholders across department, division, and company. Role requires a proactive approach in driving toward study goals.
Problem solving, prioritization, conflict resolution, and critical thinking skills
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
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