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Senior Site Contracts Specialist – Sponsor Dedicated
Location
Belgium
Posted
12 days ago
Salary
0
Seniority
Senior
Job Description
Senior Site Contracts Specialist – Sponsor Dedicated
Syneos Health
• 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.
Job Requirements
- 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
- 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
- Fluency in English, French and Dutch
- 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.
Benefits
- 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.
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• 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.
