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Site Contracts Specialist – Clinical Trials
Syneos HealthSite Contracts Specialist coordinating all contract management processes for clinical trials at Syneos Health. Supporting international sites to negotiate budgets and contracts in a fast-paced environment.
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 and to remain flexible and adaptable in stressful situations.
- 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 excellent communication.
- Quality-driven in all managed activities.
- Strong negotiating skills.
- Strong problem-solving skills.
- Ability to mentor, lead and motivate more junior staff.
- Demonstrate an ability to provide quality feedback and guidance to peers.
- Contribute to a training and Quality assurance plan within SSU and update SOPs/WI.
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.
- We are committed to building an inclusive culture – where you can authentically be yourself.
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
Contract PreparationBudget ManagementQuality ControlClinical Protocol UnderstandingSOP ComplianceMetadata CaptureDocument ArchivalClinical Trial Start-Up ProcessesMicrosoft Office Suite ProficiencyProblem-Solving Skills
Soft Skills
Excellent Communication SkillsTeam OrientationCustomer FocusOrganizational SkillsMentoring Ability