Site Contracts Specialist II – Sponsor Dedicated
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Job Description
Site Contracts Specialist managing clinical trial agreements, budgets, and start-up documentation for Syneos Health. Supporting multi-country pharmaceutical and clinical research projects.
Responsibilities:
- Administer contract management processes for protocol, informed consent, institution, investigator, vendor, consultant and customer agreements 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 country template contract and budget agreement and produce site-specific contracts
- Support negotiation of site budgets and contracts with sites, Site Contracts Service Centre, SSUL and sponsor
- Perform quality control and arrange execution and archival of clinical trial agreements and metadata capture
- 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 and follow up on outstanding issues
- Generate amended contract and budget documents and streamline contract, proposal and internal processes
- Track country/site contracting timelines and milestone progress in the SSU tracking system
- Collaborate with legal, finance and clinical operations departments 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 on SOPs and ensure quality of team work products
- Maintain and update training materials for the site contract team
- 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
- Review and comply with SOPs and WIs, update training records and ensure timesheet compliance
Requirements:
- 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
- Excellent written/oral communication, presentation, documentation, interpersonal skills and strong team-orientation
- Strong organizational skills with proven ability to handle multiple projects
- Strong negotiating and 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:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate, under the Americans with Disabilities Act
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