Site Contracts Manager - Anywhere, US This position can be located anywhere in the US; Office-based or Remote Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of \"Bringing Clinical Trials to Life,\" we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. Position Overview The Senior Sites Contract Manager is responsible for ensuring contract management skills are applied to all negotiated site contract types such that contractual, financial and legal goals are met. Identifies and ensures contractual risks are minimized. Takes leadership role for resolving significant contractual issues and, if needed, ensures timely elevation to Executive Management and/or legal counsel. Specific tasks would include: Serves as a senior contracting resource for internal and external customers. Supports Site Contracting activities: prepares and negotiates contractual agreements and budgets. Provides support and input for elevating any potentially controversial or unfavorable language to the Sponsor or internally as appropriate for preliminary review. Prepare and manage the negotiations of Site Contracts as assigned: Primary contact for clinical sites and liaison between client and clinical sites for the negotiation of site contract documents. Manages and facilitates the timely negotiation of site contractual documents in accordance with project specific timelines; anticipates and identifies potential issues and communicates to the Project Manager to prevent delay of project deliverables; targets and suggests alternative solutions and assists with the creation and implementation of a remedial action plan to facilitate the administration and timely completion of the site contractual documents. Collects, verifies and provides accounting with the I.R.S. forms required for payment, e.g., W-9 and/or Foreign Vendor Certification. Participate in internal and external project team meetings, if required. Responsible tracking the amount of time budgeted for and spent on site contract document negotiation; communicate all out-of-scope activities or over scope time to Project Management. Tracks progress of contract document negotiation in tracking tool. Provides instructions to accounting and project team to have clinical site set up in clinical trial and accounting systems. Maintains correspondence, positive relations and interaction with internal and external customers. Reviews Contract Services' policies and procedures and provides input to management. Identifies issues associated with departmental processes, provide recommendations and assist with the implementation of corrective actions. Executes special projects as needed to assist internal customers. Qualifications Bachelor's or Master's degree or equivalent in a life science, business, accounting or related field of study and a minimum of 7+ years related experience or equivalent combination of education and experience. Minimum of 4 years of CRO and legal contracts experience is needed. Global experience preferred. Advanced understanding of the clinical process (Phase I - IV) and the ramifications of change to one or more study assumptions, including timelines. Advanced knowledge of the practices, procedures, and processes involved in contract administration. Advanced knowledge of relevant laws, FDA regulations, corporate terms, conditions and policies governing assigned contracts. This position requires the ability to maintain an appropriate work pace, to perform varied tasks, to exercise logic and reasoning, to comprehend and follow instructions, and to make complex decisions. Performing the duties of this job regularly involves repetitive hand movement (at least 15 minutes) and sitting for long periods of time; involves some standing, walking, speaking, listening, grasping, reaching, crawling and lifting of up to 25 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus. If you're passionate about bringing clinical trials to life, we encourage you to apply today! Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.
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