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Project Manager
FortreaGlobal Start Up Project Manager overseeing local operational clinical trial activities. Responsible for budget management, regulatory compliance, and submissions in the United States.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Accountable for execution and oversight of local operational clinical trial activities
- Has ownership, oversight and impact on local regulatory and financial compliance
- Indirectly influence investigators, vendors, external partners, and country managers to deliver commitments
- Develop risk management and mitigation plans in country and resolve issues locally
- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols
- Works in partnership with IRB/IEC and Regulatory Authority for submission and approval interactions
Requirements
What you’ll need- University/college degree (life science preferred), or certification in a related allied health profession
- Minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
- Thorough understanding of the drug development process
- Fluent in local office language and in English, both written and verbal
- Minimum of eight (8) years of clinical research experience and SSU work 3+ years of SUPM experience
- Global submissions experience
Benefits
Comp & perks- Medical
- Dental
- Vision
- Life
- STD/LTD (multiple insurance carriers)
- 401(K)
- Paid time off (PTO) – Flex Plan
- Employee recognition awards
- Multiple ERG’s (employee resource groups)
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial executionregulatory compliancerisk managementclinical trial submissionsICH GuidelinesGCPdrug development processclinical research experienceSSU workSUPM experience
Soft Skills
leadershipcommunicationinfluenceproblem-solvingcollaboration
Certifications
university degree in life sciencecertification in allied health profession