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Site Contracts Specialist – Clinical Trials

Location

Argentina

Posted

13 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglishGoogle Cloud Platform

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.

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