Description
Syneos Health is seeking a Site Contracts Specialist to join their team in Bucharest. As a Site Contracts Specialist, you will lead multi-country projects, negotiate and prepare contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
Responsibilities:
- Lead multi-country projects, including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials
- Produce site-specific contracts from country clinical trial agreement (CTA) template, review and own site-specific contracts from country template
- Negotiate budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues
- Perform quality control and arrange execution of CTAs, as well as archival of documents into repositories and capture of metadata
- Administer all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level
- Generate amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes
- Work closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms
- Identify possible contract or process operational risk and proactively work within the team to provide solutions
- Provide support to business development and represent site contracts/Site Start-Up (SSU) at internal or customer meetings
- Collaborate with internal and external legal, finance, and clinical operations departments
- Maintain and actively support review and development of contract templates, budget templates, and site-specific files and databases
- Serve as key communication liaison between site contracts staff and internal and external customers
- Train and mentor less experienced staff members on departmental Standard Operating Procedures (SOPs)
Qualifications:
- BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience
- Moderate contracts management experience, preferably 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
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
- Good understanding of clinical protocols and associated study specifications
- Excellent communication, presentation, and interpersonal skills
- Strong negotiating skills, problem-solving skills, and ability to mentor and motivate more junior staff