Site Contracts Specialist II - Sponsor dedicated - French Speaker

Syneos Health•Montreal, QC

About The Position

Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team members act with a drug development mindset, applying their expertise to understand customer needs and shape solutions. Whether in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help customers achieve their goals. The company is agile and driven to deliver for its colleagues, customers, and patients. Syneos Health is committed to developing its people through career development, progression, supportive management, training, and a total rewards program. They are dedicated to building an inclusive culture where employees can be authentic, driven by a purpose to shape solutions that impact lives. The company continuously strives to be a desirable workplace and believes that bringing together diverse colleagues can shape the future of healthcare and accelerate patient progress.

Requirements

French Speaker
BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
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 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.

Nice To Haves

Advanced degree preferred.

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 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; 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.
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.