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Site Contracts Specialist II/Sr – Sponsor Dedicated
Syneos Health. Administer all 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 and budgets for clinical trials. Proficient in project management, vendor management, and compliance with clinical trial regulations and standards.
Highest-signal resume keywords
Contract Management ExperienceClinical Trial Process KnowledgeProject Management ExperienceNegotiation 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 Protocol ReviewSOP ComplianceMetadata CaptureMilestone TrackingDocument PreparationTraining DevelopmentProblem-Solving
Soft Skills
Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsTeam OrientationFlexibility and Adaptability
Tools & Technologies
Microsoft Office SuiteSSU Tracking SystemContract Management Software
Industry Keywords
Clinical TrialsContract Research OrganizationPharmaceutical IndustryICH GCPClinical Development Process
About the role
Key responsibilities & impact- Administer all 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 including negotiating and preparing contracts, budgets, and related documents for industry-sponsored clinical trials
- Support agreement on country template contracts and budgets and produce site-specific contracts
- Support submissions for proposed contracts and budgets for sites
- Negotiate budgets and contracts with sites through the Site Contracts Service Centre and SSUL with sponsors until issue resolution
- Perform quality control and arrange execution and archival of CTAs, including metadata capture
- Review contracts for completeness and accuracy and ensure corrections are made and documented
- Support business development and represent site contracts/Site Start-Up at internal or customer meetings
- Actively manage ongoing contract issues with Contract Managers and team members and follow up on outstanding issues
- Generate amended contract and/or budget documents and streamline contract, proposal, and internal processes
- Track milestone progress in the agreed SSU tracking system in real time and comply with country/site contracting timelines
- Collaborate with legal, finance, and clinical operations departments on legal and budgetary issues
- Facilitate execution of contracts by company signatories
- Maintain contract templates, site-specific files, and databases
- Train and mentor less experienced staff and maintain departmental training materials
- Act as communication liaison between site contracts staff and internal and external customers
- Communicate contract statuses and pending issues and prepare correspondence
- Monitor basic project financial aspects and contract hours/tasks and escalate discrepancies
- Review and comply with SOPs and WIs, update 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
- Ability to manage challenging priorities and remain flexible and adaptable in stressful situations
- 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
- Excellent written/oral communication, presentation, documentation, interpersonal, and team-orientation skills
- Strong organizational skills with proven ability to handle multiple projects
- Quality-driven approach, strong negotiating skills, and strong problem-solving skills
- 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/WIs
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, in compliance with the Americans with Disabilities Act