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Study Manager – Infectious Disease
Syneos Health. Manage interdisciplinary clinical research studies as a project manager .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing interdisciplinary clinical research studies while ensuring compliance with GCP and regulatory requirements. Proven ability to lead project teams, manage financial performance, and develop client relationships to drive business growth.
Highest-signal resume keywords
Project ManagementGood Clinical Practice (GCP)Clinical Research Organization (CRO) ExperienceRegulatory ComplianceInterpersonal Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project Financial ManagementStudy Conduct CoordinationRisk Mitigation StrategiesDatabase ManagementInspection Readiness
Soft Skills
Organizational SkillsTime ManagementPresentation SkillsInterpersonal SkillsIndependent Work
Industry Keywords
Clinical ResearchTherapeutic Area ExpertiseSOPsTMF QualityBid Defense Meetings
About the role
Key responsibilities & impact- Manage interdisciplinary clinical research studies as a project manager
- Ensure compliance with GCP, relevant SOPs, and regulatory requirements
- Act as primary liaison between the Company and the Customer
- Ensure timely study launch, conduct, and closeout
- Lead project teams to ensure quality, timelines, and budget management
- Manage project financial performance
- Coordinate study conduct partners and manage issues
- Oversee project deliverables and TMF quality and completeness
- Maintain study information in databases and systems
- Manage inspection readiness and project plans
- Plan, coordinate, and present internal and external meetings
- Prepare project management reports for clients and management
- Develop contingency plans and risk mitigation strategies
- Develop client relationships to generate future business
- Participate in bid defense meetings as a potential project manager
- May line manage project management team members and clinical monitoring staff
Requirements
What you’ll need- Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience
- Clinical research organization (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
- Direct therapeutic area expertise
- Ability to embrace new technologies
- Excellent communication, presentation, interpersonal skills, both written and spoken
- Ability to travel as necessary (approximately 25%)
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Medical, Dental and Vision health benefits
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time
- Company car or car allowance may be included