Sr Clinical Trial Manager
2 settimane fa
Sr.Clinical Trial Manager (Clinical Research Medical Advisor) - FSP - HomebasedUpdated: October 15, ****Location: BRA-RemoteJob ID:DescriptionSyneos 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 our organization easier to work for.Whether you join us as 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 about changing lives.Job ResponsibilitiesKey ResponsibilitiesLead local clinical/medical aspects of trial implementation, including protocol review, site selection support, feasibility assessments, and recruitment strategy planning.Act as the medical representative to support study design, regulatory interactions, and site training to ensure protocol adherence and patient safety.Identify pro-actively recruitment challenges or operational challenges and develop migration plans.Provide protocol/compound and indication trainings to internal and external partners.Provide medical input for Informed Consent Forms (ICFs) and safety reporting.Partner with clinical operations, regulatory, medical affairs, and external experts to optimize trial execution.Support safety oversight: review serious adverse events (SAEs), provide pharmacovigilance support, and ensure clinical data quality.Contribute to early trial start-up by validating study feasibility and supporting site engagement and training.Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and country regulations.Contribute to internal and external scientific discussions, including advisory boards and investigator meetings.Provide clinical/medical expertise for regulatory inspections, audits, and trial documentation.May work cross country.SummaryThe Sr.Clinical Trial Manager (Clinical Research Medical Advisor) is responsible for providing medical and scientific leadership to ensure the high-quality execution of clinical trials and studies in the assigned country or cluster.This role bridges Clinical Development and cross-functional teams, ensuring local medical input and compliance with regulatory standards.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.Contact: Phone: Fax: Toll-Free:Syneos Health is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email:#J-*****-Ljbffr
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