Senior Scientist, Clinical Research Operations - Ophthalmology

Merck • Boston, MA

9d • Hybrid

About The Position

This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a global, cross-functional team.

Requirements

• 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
• 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
• Degree in life sciences, preferred.
• Ophthalmology experience required.
• Accountability
• Adverse Event Report
• Biological Sciences
• Biostatistics
• Clinical Judgment
• Clinical Quality Assurance
• Clinical Research
• Clinical Sciences
• Clinical Trial Planning
• Clinical Trials
• Clinical Trials Monitoring
• Cross-Functional Collaboration
• Data Analysis
• Detail-Oriented
• Drug Development
• Ethical Standards
• Good Clinical Practice (GCP)
• Life Science
• Multiple Therapeutic Areas
• New Technology Integration
• Patient Recruitment
• Pharmacovigilance
• Prioritization
• Protocol Development

Responsibilities

• Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include:
• 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.

Benefits

• annual bonus
• long-term incentive
• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees