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Site Contracts Specialist, CRO/Pharma Experience
Syneos HealthContracts Specialist managing clinical trial agreements at Syneos Health. Leads multi-country projects with responsibilities across contract negotiations and management.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
- Produces site-specific contracts from country clinical trial agreement (CTA) template.
- Reviews and owns site-specific contracts from country template.
- Submits proposed CTA and investigator budget for site review.
- Negotiates budget and contract with site and 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.
- Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
- Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
- Works closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.
- Works closely with SSU lead, Clinical Operations and Finance to validate the load of departmental budgets and corresponding backlog.
- Identifies possible contract or process operational risk and proactively works within the team to provide solutions.
- Establishes strong working relationships with SSU lead, customer and internal project teams.
- Escalates deviations to department leadership and/or Site Contract Service Center and/or Legal Department.
- Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
- 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.
- Maintains and actively supports review and development of contract templates, budget templates and site specific files and databases.
- Serves as key 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.
- 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.
- Actively participates in higher level discussions about overall company goals, departmental objectives, and specific project aims.
- Facilitates the execution of contracts by company signatories.
- 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
- Moderate contracts management experience that includes experience in a contract research organization or pharmaceutical industry
- Management experience preferred
- 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
- Strong organizational skills with proven ability to handle multiple projects
- Excellent communication, presentation and interpersonal skills
- Quality-driven in all managed activities
- Strong negotiating skills
- Strong problem-solving skills
- Ability to mentor 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 managementclinical development processclinical trial processclinical trial start-up processesvendor managementproject managementMicrosoft Office Suitecontract research organization experiencebudget managementquality assurance
Soft Skills
customer focusedflexibleadaptableorganizational skillscommunication skillspresentation skillsinterpersonal skillsnegotiating skillsproblem-solving skillsmentoring skills