Job description
Description
Site Contracts Specialist II - Company Sponsored Studies ** Experience working on UK site contracts is required **
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
#SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
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.
Equal Opportunities Plan. Its objective is to achieve the principle of equality of opportunity in Syneos Health’s employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions.
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 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.
- Supports 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
What we’re looking for;
- 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.
Get to know Syneos Health;
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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.
Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability.
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Syneos Health Clinical
www.syneoshealth.com
Raleigh, United States
Michelle Keefe
Unknown / Non-Applicable
10000+ Employees
Company - Public
Biotech & Pharmaceuticals