Study Manager, Clinical Operations

MSD•San Diego, CA

3d•$96,200 - $151,400•Onsite

About The Position

This position contributes to the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to develop your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials.

Requirements

Working 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
Good understanding f the principles of project planning & project management
Building analytical skills to drive operational milestones
Interact with key stakeholders across department, division and company
Role requires a proactive approach driving toward study goals
Problem solving, prioritization, conflict resolution, and critical thinking skills
Solid communication, writing and presentation skills
Intermediate knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)
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
Clinical Research
Clinical Study Design
Clinical Trial Compliance
Clinical Trials
Clinical Trials Operations
Data Management
Ethical Standards
Project Management
Regulatory Compliance
Stakeholder Alignment
Structured Content Management

Nice To Haves

Degree in life sciences, preferred.

Responsibilities

May have specific operations responsibilities for a single study or across multiple studies (e.g. operational deliverables, clinical & ancillary supplies planning, lab specimen tracking, status update reports, study close-out activities).
May be responsible for tracking study timelines using project management tools.
Shares technical expertise with team members.
May interact with internal and external stakeholders (e.g. study team, vendors, committees) in support of clinical trial objectives.