Site Contracts Specialist with Clinical Trials experience Home-Based in US
Job 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 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. Provide 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 supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
- Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
- Support 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.
Qualifications:
- BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience. Advanced degree preferred.
- 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.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. 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. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary 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's qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos HealthOver 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 InformationTasks, 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.
