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Site Contracts Specialist I/II/Sr
Syneos Health. Administer contract management processes, including coordination of protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at project level .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in contract management processes, including negotiation, preparation, and execution of contracts for clinical trials. Proficient in project management, vendor management, and compliance with clinical trial regulations and standards.
Highest-signal resume keywords
Contract Management ExperienceClinical Development Process KnowledgeProject Management ExperienceNegotiating SkillsVendor Management Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Contract NegotiationBudget PreparationQuality ControlClinical Trial Process UnderstandingSOP ComplianceMetadata CaptureDocument ReviewContract ExecutionTraining and MentoringProject Financial Monitoring
Soft Skills
Organizational SkillsProblem-Solving SkillsLeadership AbilitiesCommunication SkillsAbility to Provide Feedback
Tools & Technologies
Microsoft Office SuiteSSU Tracking System
Industry Keywords
Clinical TrialsContract Research OrganizationPharmaceutical IndustryICH GCPClinical ProtocolsSite ContractsSite Start-UpTraining MaterialsQuality AssuranceFast-Paced Environment
About the role
Key responsibilities & impact- Administer contract management processes, including coordination of protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at project level
- Lead, with supervision, multi-country projects involving negotiation and preparation of contracts, budgets, and related documents for industry-sponsored clinical trials
- Support agreement on country template contracts and budgets and produce site-specific contracts
- Support negotiation of budgets and contracts with sites, Site Contracts Service Centre, SSUL, and sponsors
- Perform quality control, arrange execution of CTAs, archive documents, and capture metadata
- Review contracts for completeness and accuracy and document corrections
- Support business development and represent site contracts/Site Start-Up at internal or customer meetings
- Actively manage ongoing contract issues, follow up on outstanding issues, and generate amended contract or budget documents
- Track contracting milestones and comply with forecasted country/site contracting timelines using the SSU tracking system
- Collaborate with legal, finance, and clinical operations teams on legal and budgetary issues
- Facilitate contract execution by company signatories
- Maintain contract templates, site-specific files, and databases
- Train and mentor less experienced staff and maintain training materials
- Liaise between site contracts staff and internal and external customers regarding contract statuses and pending issues
- Monitor basic project financial aspects and contract hours/tasks and escalate discrepancies
- Follow SOPs and Work Instructions, maintain training records, and ensure timesheet compliance
Requirements
What you’ll need- BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience
- Advanced degree preferred
- High level of contracts management experience
- Experience in a contract research organization or pharmaceutical industry essential
- Strong knowledge of the clinical development process and legal and contracting parameters
- Strong computer skills in Microsoft Office Suite
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
- Good understanding of clinical protocols and associated study specifications
- Excellent understanding of clinical trial start-up processes
- Project management experience in a fast-paced environment
- Good vendor management skills
- Strong negotiating and problem-solving skills
- Strong organizational skills and ability to handle multiple projects
- Ability to mentor, lead and motivate more junior staff
- Ability to provide quality feedback and guidance to peers
- Ability to contribute to a training and Quality assurance plan within SSU and update SOPs/WI
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate, to assist employees or applicants to perform essential job functions