Site Contracts Specialist Germany Home-Based
- Experience Level
- Experienced (non-manager)
Here at Syneos Health we are currently recruiting for a Site Contracts Specialist to be based in Germany, this position may be offered home or office based. Within this role you’ll be responsible for contract / budget negotiations for your assigned studies across the DACH region.
Administers and negotiates site contracts that support projects within Clinical Operations on a global scale, with minimal oversight from the SSU Country Manager. Ensures site contract documentation is in compliance with sponsor and Company requirements. Identifies project and/or country level and/or individual site contract related problems and works with internal and external team members to provide and implement solutions. Serves as subject matter expert across all Site Contracts functions. Trains and mentors site contracts staff and proactively identifies ways to improve internal project operations. Establishes strong working relationships with customers, internal project teams and sites. May lead internal team education or process improvement initiatives. Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Produces site-specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review.
Negotiates budget and contract with site and 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.
Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
Works closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.
Identifies possible contract or process operational risk and proactively works within the team to provide solutions.
Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
Maintains and actively supports review and development of contract templates, budget templates and site specific files and databases.
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.
The ideal candidate will need the following experience / skills to be considered:
BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
Min.2 years of 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
Strong organizational skills
Fluency in German and English language
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.