Contract Management Assistant (FSP, sponsor dedicated) Hybrid/Remote

Syneos Health, Inc.; United States; Hybrid; USD 52,000 - 70,000; Full time

Job summary

Syneos Health is seeking a Contract Management Assistant (FSP, sponsor dedicated) to support Site Start-Up activities across multiple regions in a hybrid/remote role. You will help manage investigator site contracts, regulatory submissions, essential documents, and TMF alignment, collaborating with global teams and sponsors.

Strong English, multitasking, and IT skills are essential; experience with contract processes, budgets, and vendor documents is a plus.

Qualifications

• Fluent in English.
• Multilingual advantage.
• Associate’s Degree or equivalent combination of education and training preferred.
• Strong computer skills, including Word, Excel, PowerPoint, Publisher.
• Energetic, adaptable, and quick-thinking with the ability to work in a fast-paced environment supporting Italy.
• Ability to interact effectively with investigative site personnel and internal stakeholders.
• Good organizational skills and attention to detail.
• Demonstrated ability to work independently, as well as part of a team.

Responsibilities

• Assist in administration of contract management and essential document processes at project, country, and site level.
• Coordinate with protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents.
• Assist with quality control and translation related to submissions, contracts, and essential documents.
• Assist in negotiations of budget and contracts with sites via Site Contracts Service Center and SSUL with Sponsor.
• Review contracts for completeness and accuracy and document corrections.
• Prepare contract management documentation and streamline processes.

Skills

Fluent in English

Multilingual advantage

Independent and team collaboration

Education

Associate’s Degree or equivalent

Tools

Word

Excel

PowerPoint

Publisher

Job description

Description

Contract Management Assistant (FSP, sponsor dedicated) Hybrid/Remote

Description

Contract Management Assistant (FSP, sponsor dedicated) Hybrid/Remote Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 the goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know:

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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

As a Contract ManagementAssistantyou willbe responsible forproviding assistancein the delivery of Site Start-Up (SSU) activities in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and essential documentsrequiredfor site initiation.

Support projects within Clinical Operations on a global scale, with oversight from the SSU Country Manager and Central and Shared Services leadership.

Ensures regulatory and site contract documentationcomplies withsponsor and Company requirements.

Works with internal and external team members to implement solutions for project and/or individual site contract related problems. Establishes strong working relationships with customers, internal projectteamsand sites.Ensuresall relevant documents aresubmittedto the Trial Master File (TMF) as per Company Standard Operating Procedure (SOP)/Sponsor requirements.

JobResponsibilities

Assistsin administration of contract management and essential document processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project,countryand site level.

• Assistswith quality control processes and translation processes related to submissions,contractsand essential documents.
• Under supervision mayassistin negotiations of budget and contracts with site and via Site Contracts Service Center and SSUL with Sponsor until resolution of issues.
• Assistsin the reviews of contracts for completeness andaccuracy, andensures that corrections are appropriately made and documented.
• Assistsin providing and 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.

Qualification Requirements

• Fluent in English
• Multi language advantage
• Associate’s Degreeor equivalent combination of education and training preferred.
• Strong computer skills, including Word, Excel, PowerPoint, Publisher.
• Energetic, adaptable, and quick-thinking with the ability to work efficiently in a fast-paced environment supporting Italy;
• Ability to interact effective ly and appropriately with investigative site personnel and internal stakeholders.
• Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
• Demonstrated ability to work independently, as well as part of a team.

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.