Description
Syneos Health is seeking a Site Contract Specialist (FSO) to join their team. The successful candidate 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
- Generate amended contract and/or budget documents as necessary
- 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 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 clinical protocols and associated study specifications
- Excellent communication, presentation and interpersonal skills
- Strong negotiating skills
- Strong problem-solving skills
- Ability to mentor and motivate more junior staff