Senior Laboratory Project Services Manager
$83,000–$173,000 year
RemoteMarietta, Georgia, United States
Job Summary
Lead study setup activities, including protocol and budget review, project planning, milestone tracking, and risk, issue, and action log management. Partner with Study Setup teams to support quality database setup, oversee preparation of protocol-specific documentation, and manage study timelines, deliverables, eTMF filing, monitoring, reporting, and closeout activities. Build customer relationships, facilitate communication, coordinate issue resolution, and lead meetings, presentations, and governance activities. Represent the company at investigator meetings, audits, and inspections while providing study training to sites, CRAs, and customers. Support process improvement projects, department-level assignments, mentoring, and best-practice development.
Required Qualifications
- Bachelor's Degree Life Sciences or related field
- 5+ years of clinical or research industry experience
- 3 year project management / project set up experience
- Thorough knowledge of Project Management processes
- Thorough knowledge of the company laboratory processes
- Thorough understanding of medical and clinical research terminology
- Demonstrated ability to work in a fast-paced environment
- Strong organizational skills
- Demonstrated ability to meet deadlines
- Strong written and verbal communication skills
- Good command of English language
- Ability to establish and maintain effective working relationships with coworkers, managers, and customers
- Ability to serve as an escalation point and coordinate study or program level issue resolution
- Ability to mentor, train, and provide feedback on team performance
Desired Qualifications
- Demonstrated computer proficiency with Microsoft Office and the company systems
- Equivalent experience with similar Centralized Laboratory systems
- Experience managing study documentation throughout the project lifecycle, including filing into eTMF
- Experience in successfully leading large, global and complex Phase I-IV clinical trials
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