Project Manager I, RWE

Syneos Health

Project Manager overseeing drug development collaboration at Syneos Health. Creating and maintaining trial files and coordinating study deliverables with internal teams and vendors.

Posted 6/30/2026full-timeRemote • Arizona, Maine, Ohio, Rhode Island • 🇺🇸 United StatesMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Creates and maintains the Trial Master File Management (TMF) Plan.
Routinely reviews the TMF to ensure quality, completeness and inspection readiness
Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors.
Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure
Assists with identification of and contracting with approved vendors, as necessary
Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary
Assists with development and implementation of change orders
Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently
Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones
Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management
Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting
Attends financial review meetings to assist with reconciliation and identification of budget overrun
Reviews and approves invoices from sites or vendors and to the client
Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.
May participate in Customer proposal development
In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings
Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
Develops knowledge of current therapeutic environment

Requirements

What you’ll need

Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred
Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred.
CRO and relevant therapeutic experience preferred
Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
Strong organizational skills
Strong ability to manage time and work independently
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
High level of competency in English language
Proficiency with MS Office Applications
Ability to travel as necessary (up to 25%)

Benefits

Comp & perks

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself.

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Trial Master File ManagementGood Clinical PracticeICH GuidelinesFinancial ReportingMetric ReportingResource ManagementContingency PlanningRisk Mitigation StrategiesInterim AnalysesDatabase Management

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsInterpersonal SkillsFlexibilityTime Management