Site Contracts Specialist II – Sponsor Dedicated (Genentech)

Syneos Health • Morrisville, NC

19h • Remote

About The Position

Site Contracts Specialist II – Sponsor Dedicated (Genentech) 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. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Requirements

• Bachelor's degree in a related field or equivalent experience
• Moderate contracts management experience that includes experience in a contract research organization or pharmaceutical industry
• Practical knowledge of a professional area, typically obtained through education combined with experience
• Strong understanding of regulations, SOPs, and project requirements related to site identification
• Excellent negotiation and communication skills
• Ability to manage and review site performance metrics
• Experience in managing site confidentiality agreements (CDAs) and site information forms (SIFs)
• Strong organizational and time management skills
• Ability to work independently and as part of a team
• Proficiency in using relevant software and tools for site management
• Detail-oriented with strong analytical skills
• Ability to handle multiple tasks and projects simultaneously

Nice To Haves

• Relevant certifications in clinical research or site management preferred

Responsibilities

• May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• 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.
• Works closely with SSU lead, Clinical Operations and Finance to validate the load of departmental budgets and corresponding backlog.
• Identifies possible contract or process operational risk and proactively works within the team to provide solutions.
• Establishes strong working relationships with SSU lead, customer and internal project teams.
• Escalates deviations to department leadership and/or Site Contract Service Center and/or Legal Department.
• Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• 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.
• Maintains and actively supports review and development of contract templates, budget templates and site specific files and databases.
• Serves as key 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.
• 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.
• Actively participates in higher level discussions about overall company goals, departmental objectives, and specific project aims.
• Facilitates the execution of contracts by company signatories.
• 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.

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself.
• Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level