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Site Contracts Specialist – Clinical Trials
Location
Argentina
Posted
13 days ago
Salary
0
Seniority
Senior
Job Description
Site Contracts Specialist – Clinical Trials
Syneos Health
• 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.
Job 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.
- 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
- 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.
