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About the role
Key responsibilities & impact- Lead the initiation, maintenance and close out activities of multi-center studies in accordance with the protocol, relevant SOPs, Good Clinical Practice, international standards, and regulatory requirements
- Plan and procure team resources as needed to complete study activities according to scope, budget, and timeline
- Develop and/or oversee development of study plans such as project management (including communication), monitoring, risk management, data management and safety plans
- Coordinate activities with central laboratories and other external service providers/vendors
- Review and negotiate site budgets and contracts
- Initiate and participate in the development of change orders to sponsor and/or site contracts and budgets
- Maintain appropriate and effective communication with sponsor, external service providers, and other internal departments to ensure successful project completion
Requirements
What you’ll need- Bachelor's degree required, preferably in science, nursing, other biomedical discipline, or equivalent
- Clinical research experience as a CRA or Research Coordinator is preferred
- Experience in support of business development processes; including budgets, proposals and bid defense planning and execution
- Ability to work across multiple projects
- Experience with renal and hepatic impairment, infectious disease and tobacco studies is an asset
- Flexible and willing to travel up to 30% (regional)
- Excellent problem-solving and decision making skills
Benefits
Comp & perks- Celerion Values: Integrity Trust Teamwork Respect
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 researchproject managementdata managementrisk managementbudget managementcontract negotiationstudy plan developmentGood Clinical PracticeSOPsmulti-center studies
Soft Skills
communicationproblem-solvingdecision makingflexibilityorganizational skillsteam leadershipcollaborationadaptabilitytime managementinterpersonal skills
Certifications
Bachelor's degree
