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Syneos Health, Inc.; Montrouge; À distance; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading biopharmaceutical solutions organization is seeking a Site Contracts Specialist II to administer and negotiate site contracts for clinical operations. This role requires fluency in English and French, strong contracts management experience, and the ability to mentor junior team members. The ideal candidate will have a BA/BS degree in a relevant field and experience in a contract research organization or pharmaceutical industry. This position is home-based and offers the opportunity to impact global clinical trials.

Qualifications

• High level of contracts management experience.
• Experience in a contract research organization or pharmaceutical industry essential.
• Strong knowledge of the clinical development process and legal and contracting parameters.

Responsabilités

• Administers all contract management processes for clinical trials.
• May lead multi-country projects including negotiating contracts.
• Provides support to business development and represents site contracts at meetings.

Connaissances

Fluency in English

Fluency in French

Contracts management

Project management

Negotiation skills

Vendor management

Customer focus

Strong organizational skills

Formation

BA/BS degree in Business Administration or related field

Advanced degree preferred

Outils

Microsoft Office Suite

Description du poste

Description

Site Contracts Specialist II or Senior - Sponsor dedicated - Home Based. Fluency in English and French essential.

Location: Montrouge, 1, France

Job ID: 25100355

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. Provide support in submissions for proposed contract and budget for site.
• 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; 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 real time in the SSU tracking system.
• 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 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.
• Reviews and complies with SOPs and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

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.
• Experience in a contract research organization or pharmaceutical industry essential.
• 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.
• Excellent written/oral communication, presentation, documentation, interpersonal skills as well as strong team-orientation.
• Strong organizational skills with proven ability to handle multiple projects and communicate effectively.
• Quality-driven in all managed activities. Strong negotiating and 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 training and quality assurance plans within SSU and update SOPs/WIs.

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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Administers and negotiates site contracts that support projects within Clinical Operations on a global scale, with moderate oversight from the SSU Country Manager. Ensures site contract documentation is in compliance with sponsor and Company requirements. Identifies project and/or individual site contract related problems and works with internal and external team members to provide and implement solutions. Serves as technical expert across all Site Contracts functions. Trains and mentors junior team members and proactively identify ways to improve internal project operations. Establishes strong working relationships with customer, internal project teams and sites. Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.May participate in internal team education or process improvement initiatives.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to:

Syneos Health (Nasdaq:SYNH) 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.