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Site Contracts Specialist, Polish Required
Syneos HealthContract Specialist managing site contracts for clinical trials in a global environment. Collaborating within a clinical solutions team to streamline processes and support project execution.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level
- May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials
- Provides support to SSUL to agree on country template contract and budget
- Produces site-specific contracts from country template
- Provide support in submissions for proposed contract and budget for site
- Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues
- Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata
- Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented
- Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings
- Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues
- Support in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions
- Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time
- Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues
- Facilitates the execution of contracts by company signatories
- Maintains contract templates and site specific files and databases
- Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products
- Maintains and updates training material for site contract team
- Acts as a communication liaison between site contracts staff and internal and external customers
- Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues
- Prepares correspondence as necessary
- Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion
- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures 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
- Customer focused and ability to manage challenging priorities
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
- Good understanding 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 as well as strong team-orientation
- Strong organizational skills with proven ability to handle multiple projects
- Strong negotiating skills
- Strong problem-solving skills
- Ability to mentor, lead and motivate more junior staff
Benefits
Comp & perks- We are passionate about developing our people, through career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Committed to building an inclusive culture
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
Contracts ManagementClinical Development ProcessClinical Trial Start-Up ProcessesBudget PreparationQuality ControlDocument ArchivalMetadata CaptureSOP ComplianceProject TrackingContract Documentation
Soft Skills
Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsProblem-Solving SkillsTeam Orientation