Description - External
Site Contracts Specialist I
Syneos Health® is a 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.
Job responsibilities
61 Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
61 Supports the SSUL to agree on country template contract and budget. Assists in producing site-specific contracts from country template.
61 Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SSUL lead with Sponsor until resolution of issues.
61 Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
61 Assists in the reviews of contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
61 Assists SSU leads, Managers or other site contracts staff with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
61 Assists in 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.
61 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.
61 Collaborates with internal and external legal, finance, and clinical operations departments including communicating and explaining legal and budgetary issues for contract management tasks and issues.
61 Facilitates the execution of contracts by company signatories.
61 Supports the maintenance of contract templates and site specific files and databases.
61 Serves as 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.
61 Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
61 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.
61 Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Qualifications - External
What we’re looking for
61 BA/BS degree in related field or equivalent combination of education and experience
61 Clinical research, contracts, or related experience that includes working in a team-oriented environment preferred
61 Strong skills in Microsoft Office Suite, email, and voicemail
61 Strong organizational, presentation, documentation, and interpersonal skills
61 Ability to handle multiple tasks to meet deadlines in a dynamic environment
61 Good understanding of clinical trial process across Phases II-IV and ICH GCP Ability to interact effectively and appropriately with investigative site personnel
61 Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively
61 Ability to take direction from multiple individuals and set priorities accordingly
61 Ability to effectively communicate across multiple function groups (clinical team, PM, Director) Demonstrated ability to work independently, as well as part of a team
61 Utilize problem-solving techniques effectively
61 Quality-driven in all managed activities
61 Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions
61 Strong computer skills, including Word, Excel
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.
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.