Sr. Scientist, Clinical Operations
Merck
10 days ago
Remote friendly (North Wales, PA)
United States
Operations
Job Description
This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof, applying project management, communication, and collaboration skills in support of clinical trials.
Ophthalmology/Retina Related Experience Required.
Job Responsibilities
- Responsible for the operational planning, feasibility, and execution of a clinical trial.
- May serve as the clinical trial team lead.
- May lead key study planning, development, and execution elements (data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, status update reports, study close out).
- Leads timeline management, risk identification and mitigation, and issue resolution.
- Facilitates and collaborates with internal/external stakeholders (study team, country teams, vendors, committees).
- Accountable for managing study-specific partners and/or vendors.
Core Skills
- Solid knowledge of clinical research regulatory requirements (GCP, ICH).
- Project planning/project management principles; manage multiple priorities.
- Analytical skills to drive operational milestones.
- Ability to influence decisions of internal/external customers/vendors; proactive leadership in a matrix environment.
- Leadership, meeting facilitation, problem solving, conflict resolution.
- Strong communication, writing, and presentation skills.
- Intermediate Microsoft Office (Excel, PowerPoint, Word, Outlook).
Education & Experience
- Bachelor’s +5 years, or Master’s +3 years, or PhD/PharmD in pharmaceutical/clinical drug development, project management, and/or medical field experience.
- Life sciences degree preferred.
Required Skills
- Clinical Operations/Research/Trial Management, Clinical Trial Compliance, Clinical Study Design, Risk Monitoring/Identifying Risks, Regulatory Compliance/Documents, Ethical Standards, Medical Writing, Data Analysis, Project Management.
Preferred Skills
- Current Employees apply HERE; Current Contingent Workers apply HERE.
This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof, applying project management, communication, and collaboration skills in support of clinical trials.
Ophthalmology/Retina Related Experience Required.
Job Responsibilities
- Responsible for the operational planning, feasibility, and execution of a clinical trial.
- May serve as the clinical trial team lead.
- May lead key study planning, development, and execution elements (data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, status update reports, study close out).
- Leads timeline management, risk identification and mitigation, and issue resolution.
- Facilitates and collaborates with internal/external stakeholders (study team, country teams, vendors, committees).
- Accountable for managing study-specific partners and/or vendors.
Core Skills
- Solid knowledge of clinical research regulatory requirements (GCP, ICH).
- Project planning/project management principles; manage multiple priorities.
- Analytical skills to drive operational milestones.
- Ability to influence decisions of internal/external customers/vendors; proactive leadership in a matrix environment.
- Leadership, meeting facilitation, problem solving, conflict resolution.
- Strong communication, writing, and presentation skills.
- Intermediate Microsoft Office (Excel, PowerPoint, Word, Outlook).
Education & Experience
- Bachelor’s +5 years, or Master’s +3 years, or PhD/PharmD in pharmaceutical/clinical drug development, project management, and/or medical field experience.
- Life sciences degree preferred.
Required Skills
- Clinical Operations/Research/Trial Management, Clinical Trial Compliance, Clinical Study Design, Risk Monitoring/Identifying Risks, Regulatory Compliance/Documents, Ethical Standards, Medical Writing, Data Analysis, Project Management.
Preferred Skills
- Current Employees apply HERE; Current Contingent Workers apply HERE.