Site Contract Manager

4 semanas atrás


São Paulo, Brasil Medpace Tempo inteiro

Join Medpace at our Sao Paulo office Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Site Contract Manager to join our LatAm Site Contracts team within the Clinical Operations department. This position will report to the LatAm Senior Contract Manager and will play a key role in the study start-up and clinical trial management processes at Medpace. The Contract Manager will play a key role in advancing the start-up of our projects. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities Act as Contract Study Lead on allocated studies with active responsibility for theperformance of the contract team assigned to the study, acting as a primary point ofcontact between Sponsor and study teams, determining site contract processes, delegatingduties to staff, and providing functional oversight of site contract and budget negotiations; Create project-specific site contract documents, including study templates; Review contract queries that fall outside of agreed parameters escalated by ContractSpecialists; Ensure Contract staff provide timely and accurate budget and contract review andexecution, as well as meaningful updates in ClinTrak; Facilitate clear communication, evaluation, and reporting of ongoing contract negotiationsto study teams (e.g., Clinical Trial Management, Regulatory Submissions), ensuring thattimelines are met, delays are managed effectively, and study team and Sponsor concernsare addressed as appropriate; Provide contract support and advice related to site payments, site contracts, and otherrelated documents and vendor contracts, identifying potential contractual issues,addressing, escalating and/or resolving such in order to minimize contractual risk to theorganization; Support in the development and implementation of contract management and complianceinitiatives; Line manage local or remote staff where applicable, including recruitment, training anddevelopment, and functional oversight of staff; and May be responsible for other projects and responsibilities as assigned. Qualifications Bachelor’s degree, preferably in the area of Business, Life Sciences, or Law, with 4 years ofclinical research industry experience, in clinical operations with contract managementexperience, or Juris Doctorate/Advanced education in the field of law and 2 years of clinicalresearch industry experience with contract management experience; Experience with LATAM Site Contracts required; US project experience preferred; Broad knowledge of clinical trial conduct, standards of Good Clinical Practice, andapplicable regulations and laws; Demonstrated knowledge and ability to review and revise contracts for legal implications;and Demonstrated ability to successfully motivate and collaborate with internal and externalstudy team members, including Contract Specialists without direct reporting relationship. Fluency in English ***We kindly ask to submit CV in English Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities. Organic Growth: Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO. Perks (vary by location and position): On-site fitness center(s) Campus walking paths Company-sponsored social and wellness events Official Sponsor of FC Cincinnati Hybrid work-from-home options and flexible work schedule On-site Market Place Free and covered parking Discounts for local businesses On campus restaurantsand banks coming soon Awards: Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer Recognized by Forbes as one of America's Best Mid-size Companies in 2021 Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati What to Expect Next: A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview. EO/AA Employer M/F/Disability/Vets Bachelor’s degree, preferably in the area of Business, Life Sciences, or Law, with 4 years ofclinical research industry experience, in clinical operations with contract managementexperience, or Juris Doctorate/Advanced education in the field of law and 2 years of clinicalresearch industry experience with contract management experience; Experience with LATAM Site Contracts required; US project experience preferred; Broad knowledge of clinical trial conduct, standards of Good Clinical Practice, andapplicable regulations and laws; Demonstrated knowledge and ability to review and revise contracts for legal implications;and Demonstrated ability to successfully motivate and collaborate with internal and externalstudy team members, including Contract Specialists without direct reporting relationship. Fluency in English ***We kindly ask to submit CV in English Act as Contract Study Lead on allocated studies with active responsibility for theperformance of the contract team assigned to the study, acting as a primary point ofcontact between Sponsor and study teams, determining site contract processes, delegatingduties to staff, and providing functional oversight of site contract and budget negotiations; Create project-specific site contract documents, including study templates; Review contract queries that fall outside of agreed parameters escalated by ContractSpecialists; Ensure Contract staff provide timely and accurate budget and contract review andexecution, as well as meaningful updates in ClinTrak; Facilitate clear communication, evaluation, and reporting of ongoing contract negotiationsto study teams (e.g., Clinical Trial Management, Regulatory Submissions), ensuring thattimelines are met, delays are managed effectively, and study team and Sponsor concernsare addressed as appropriate; Provide contract support and advice related to site payments, site contracts, and otherrelated documents and vendor contracts, identifying potential contractual issues,addressing, escalating and/or resolving such in order to minimize contractual risk to theorganization; Support in the development and implementation of contract management and complianceinitiatives; Line manage local or remote staff where applicable, including recruitment, training anddevelopment, and functional oversight of staff; and May be responsible for other projects and responsibilities as assigned. #J-18808-Ljbffr


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