Scientist, Clinical Operations - Hybrid

MSD•Rahway, NJ

10d•Hybrid

About The Position

Responsible for specific clinical/scientific activities on a single study or across multi e studies (e.g., medical monitoring, lab specimen tracking/reconciliation, adjudication support, preparation of meeting materials). 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. Core Skills: 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 Education/Experience: 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. clinicaltrialjobs EligibleforERP

Requirements

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
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
Accountability
Adaptability
Analytical Problem Solving
Biomedical Sciences
Clinical Data Interpretation
Clinical Quality Assurance
Clinical Research
Clinical Study Design
Clinical Trial Compliance
Clinical Trials
Clinical Trials Operations
Conflict Resolution
Data Management
Drug Development
Ethical Standards
Healthcare Operations
Innovation
IT Demand Management
Life Science
Machine Learning (ML)
Medical Writing
Pharmaceutical Development
Prioritization
Project Management

Nice To Haves

Degree in life sciences, preferred.

Responsibilities

Responsible for specific clinical/scientific activities on a single study or across multi e studies (e.g., medical monitoring, lab specimen tracking/reconciliation, adjudication support, preparation of meeting materials)
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