Site Contracts Specialist II
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Job Description
Site Contracts Specialist II managing clinical-trial contracts, budgets, and site start-up for Syneos Health. Supporting global pharmaceutical and clinical research programs through negotiation, execution, and compliance.
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 contract and budget negotiation and preparation for industry-sponsored clinical trials
- Support country template contract and budget agreement and produce site-specific contracts
- Support submissions and negotiate contracts and budgets with sites, Site Contracts Service Centre, SSUL, and sponsors
- Perform quality control, arrange execution of clinical trial agreements, archive documents, and capture metadata
- Review contracts for completeness and accuracy and ensure corrections are documented
- Support business development and represent site contracts/Site Start-Up at internal or customer meetings
- Manage ongoing contract issues, follow up on outstanding items, and generate amended contract or budget documents
- Track country/site contracting timelines and milestone progress in the SSU tracking system
- Collaborate with legal, finance, and clinical operations teams and facilitate contract execution by company signatories
- Maintain contract templates, site-specific files, and databases
- Train and mentor less experienced staff and maintain training materials
- Act as communication liaison 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 and maintain training and timesheet records
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
- Strong negotiating skills
- 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/WI
- Customer-focused, flexible, adaptable, and able to manage challenging priorities in stressful situations
- Excellent written/oral communication, presentation, documentation, interpersonal, organizational, and team-oriented skills
- Quality-driven with proven ability to handle multiple projects
- Must comply with SOPs, WIs, training records, and timesheet requirements
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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