Site Contracts Specialist with experience in Clinical Trials, Home-Based Mexico, Brazil and Argentina<\/p>\n
Syneos Health\u00ae 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. <\/p>\n
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.<\/p>\n
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you\u2019ll 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.<\/p>\n
Discover what our 29,000 employees, across 110 countries already know: <\/p>\n
\u2022 May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.<\/p>\n
\u2022 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.<\/p>\n
\u2022 Negotiates budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.<\/p>\n
\u2022 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.<\/p>\n
\u2022 Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.<\/p>\n
\u2022 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.<\/p>\n
\u2022 Works closely with Site Contract Service Center andLegal to harmonize site contract to reflect sponsor’s master service agreement terms.<\/p>\n
\u2022 Works closely with SSU lead, Clinical Operations and Finance to validate the load of departmental budgets and corresponding backlog.<\/p>\n
\u2022 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.<\/p>\n
\u2022 Provides support to business development and represents site contracts\/Site Start-Up (SSU) at internal or customer meetings.<\/p>\n
\u2022 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.<\/p>\n
\u2022 Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.<\/p>\n
\u2022 Maintains and actively supports review and development of contract templates, budget templates and site specific files and databases.<\/p>\n
\u2022 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.<\/p>\n
\u2022 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.<\/p>\n
\u2022 Actively participates in higher level discussions about overall company goals, departmental objectives, and specific project aims.<\/p>\n
\u2022 Facilitates the execution of contracts by company signatories.<\/p>\n
\u2022 Monitors basic financial aspects of the project and the number of hours\/tasks available per contract; escalates discrepancies in a timely fashion.<\/p>\n
\u2022 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.<\/p>\n
\u2022 BA\/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience. Advanced degree preferred<\/p>\n
\u2022 Moderate contracts management experience that includes experience in a contract research organization or pharmaceutical industry<\/p>\n
\u2022 Strong knowledge of the clinical development process and legal and contracting parameters<\/p>\n
\u2022 Strong computer skills in Microsoft Office Suite<\/p>\n
\u2022 Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations<\/p>\n
\u2022 Excellent understanding of clinical trial process across Phases II-IV and ICH GCP<\/p>\n
\u2022 Good understanding clinical protocols and associated study specifications<\/p>\n
\u2022 Excellent understanding of clinical trial start-up processes<\/p>\n
\u2022 Project management experience in a fast-paced environment<\/p>\n
\u2022 Good vendor management skills Strong organizational skills with proven ability to handle multiple projects<\/p>\n
\u2022 Excellent communication, presentation and interpersonal skills<\/p>\n
\u2022 Quality-driven in all managed activities<\/p>\n
\u2022 Ability to mentor and motivate more junior staff<\/p>\n
\u2022 Demonstrate an ability to provide quality feedback and guidance to peers<\/p>\n
\u2022 Contribute to a training and Quality assurance plan within SSU and update SOPs\/WI The annual base salary for this position ranges from $56,000 to $95,000. At Syneos Health, it is not typical for a candidate to be hired near the minimum or maximum of the pay range. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate\u2019s qualifications, skills, competencies, and proficiency for the role.<\/p>\n
\u0627\u0644\u0645\u0648\u0642\u0639:<\/b> This is a remote\/home-based position open to candidates located anywhere within the United States.<\/p>\nGet to know Syneos Health<\/h3>\n
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.<\/p>\n
No matter what your role is, you\u2019ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.<\/p>\n