Description
Syneos Health is seeking a Site Contracts Specialist with experience in Clinical Trials. 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.
- 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.
- 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 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.
- Strong negotiating skills.
- Strong problem-solving skills.
- Ability to mentor and motivate more junior staff.
Benefits: Syneos Health offers a comprehensive benefits package, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.
Salary: The annual base salary for this position ranges from $56,000 to $95,000.