Sponsor Dedicated Site Contracts Specialist II - Home Based Italy/Spain/France
Updated: Yesterday
Location: France-Europe - FRA-Home-Based
Job ID: 25003102
Sponsor Dedicated Site Contracts Specialist II - Home Based in Italy or Spain or France
Previous experience in site contracts negotiation with sites in Italy and in Spain or France is essential.
Fluency in Italian and Spanish or French is required.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Job Responsibilities
* 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.
* 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 support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
* Works with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
* Supports 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.
* Experience with Italian sites/budgets, plus experience in Spain or France.
Qualifications
* 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 with Italian sites and Spanish or French sites.
* Fluency in Italian and Spanish or French is requested for the role.
* Experience in a contract research organization or pharmaceutical industry essential.
* Strong knowledge of the clinical development process and legal and contracting parameters.
* 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.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.
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