Site Contracts Specialist II
Syneos Health 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. 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
- Comprehensive knowledge of clinical development process and importance of meeting major study milestones.
- Site contracting and study budget benchmarking/fair market value analysis experience.
- Supplier relationship management experience with demonstrated success at the operational level; experience at both a CRO and other pharmaceutical companies.
- Demonstrated ability to effectively communicate (written and verbal) and influence key stakeholders at all levels of the organization and externally.
- Proven ability to identify legal language and budget related problems and works with internal and external team stakeholders to provide and implement solutions.
- Ability to establish strong working relationships with internal and external stakeholders (e.g., legal, compliance, finance, and sites).
- Supports Investigator Contracting, Benchmarking, and Payments US operational initiatives.
- Serves as main point of contact for internal and external stakeholders to meet site contracting/budgeting goals.
- Establishes, maintains, and updates training material for legal language and budget parameters for team and clinical site contract negotiators.
- Serves as subject matter expert equipped to help resolve US legal language and site budgeting issues, and escalation point within the Company for internal stakeholders to seek assistance.
- Liaise with study team members to understand study specifics (enrollment goals, timelines, etc.) and provides study status reports including challenges and lessons learned.
- Works closely with US Legal Liaison to address and finalize legal language escalations.
- Performs other work-related duties as assigned and following Standard Operating Procedures (SOPs) and Guidance documents.
- Ensures investigator budget development and documentation complies with SOPs, guidance, and requirements.
- Generates site-specific agreements using approved templates and any applicable study parameters.
- Proposes site budgeting solutions to issues that may arise during development/negotiations of contract/budget cycle to enhance negotiation strategy and ensure deliverables are met.
- Establishes strategies around investigator budget template development and/or budget negotiation parameters to reflect sponsor specific specifications, communications, and required processes. Initiates and introduces creative ideas and solutions.
- Responsible for tracking the status of pending contracts and identifying outstanding issues in site agreements.
- Works with study leads/SMEs to negotiate contract terms and conditions using fall back language and in collaboration with the US legal liaison, functional teams, and sites. Ensures agreements are clear, comprehensive, and complete.
- Involved in ensuring the accuracy of algorithms for Purchase Order values per payee are accurate based upon final negotiations and on enrollment expectations.
- Develops detailed investigator grant per patient budget estimates according to protocol specifications through currently available software package/resources/FMV tools.
- Updates detailed investigator grant per patient budget estimates template according to protocol amendment specifications.
- Follows escalation process for deviations and escalates to the appropriate point of contact when needed.
- Creates, populates, and maintains study tracker, status reports, and updates department spreadsheets/logs.
- Ensures proper quality reviews and checks are conducted on clinical site agreements and are archived in accordance with relevant policies and processes.
- Comfortable with training and mentoring other members of staff.
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 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.
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