Lead clinical execution of trials for a global healthcare company. Oversee study protocol adherence and collaborate with cross-functional teams in clinical research initiatives.
Responsibilities
Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s).
Serving as the lead clinical scientist on the clinical trial team.
Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.
Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments);
Partners with the Study Manager on study deliverables.
Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
Providing tactical/scientific mentorship to other clinical scientists.
Requirements
Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master’s Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree in life sciences, preferred.
Ophthalmology experience required.
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
Strong 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, strategic thinking and leadership in driving toward study goals.
Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division.
Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment.
Problem solving, prioritization, conflict resolution, and critical thinking skills.
Build team capabilities through proactive coaching.
Strong communication, technical writing, and presentation skills.
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days
Job title
Senior Scientist, Clinical Research Operations – Ophthalmology
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