Sr. Scientist, Clinical Operations

Merck•North Wales, PA

2d•$117,000 - $184,200•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. Ophthalmology/Retina related experience required.

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
Problem solving, prioritization, conflict resolution, and critical thinking skills
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
Adaptability
Clinical Data
Clinical Data Interpretation
Clinical Operations
Clinical Quality Assurance
Clinical Research
Clinical Study Design
Clinical Trial Compliance
Clinical Trial Management
Clinical Trials
Conflict Resolution
Critical Thinking
Cross-Functional Collaboration
Data Analysis
Drug Development
Ethical Standards
ICH GCP Guidelines
Life Science
Medical Writing
Motivation Management
Prioritization
Problem Solving
Regulatory Compliance
Regulatory Documents
Scientific Publications

Nice To Haves

Ophthalmology/Retina related experience
Degree in life sciences

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.
Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment.
Build team capabilities through proactive coaching