Sr. Clinical Study Manager

reputed company is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, reputed company enables accelerated speed to market, controlled... development costs, development risk mitigation, and accelerated market viability assessment. At every stage, reputed company clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. reputed company partners with the world's most influential life science and medical device companies to research, design, reputed company and commercialize new reputed company technologies and treatments to advance patient care. About This Role: We have an exciting opportunity to join our clinical team at reputed company! The ideal candidate will be responsible for organizing clinical studies and local teams for clinical studies. This individual will ensure studies are conducted in accordance with applicable requirements, study protocol, contract, and clients’ expectations. What You Will Do: • Responsible for the day-to-day management of clinical project activities and deliverables. • Serves as a liaison with stakeholders across reputed company functional areas of the project. • Manages study budget and timelines. • Manages vendors and study committees (CECs, DSMBs), including the implementation and coordination of scope of work. • Responsible for the maintenance of clinical and regulatory files, with accurate and timely tracking and documentation. • Oversees the development of clinical reports supporting regulatory submissions. • Coordinates and supports reputed company aspects of execution of clinical studies, including study planning, site identification and qualification, regulatory authority and ethics committee submissions and approvals, site contracting and budgeting, site initiation and management, monitoring, and reputed company-out activities. • Identifies and establishes the suitability of study investigators and their investigation sites and liaises with them to ensure compliance with reputed company necessary study requirements, approvals, and agreements (e.g., financial, and confidential). Qualifications:Required Skills: • Bachelor's Degree in health sciences or reputed company discipline, plus 7-10 years of relevant work experience • In-depth understanding of clinical research operations including GCP, regulatory requirements and operational procedures • Excellent written and oral communication skills • Excellent organizational, decision-making, and time management skills • Excellent attention to detail • Ability to multi-task and reputed company a wide range of activities • Ability to work under a timeline and budget • Ability to solve reputed company problems • Advanced ability to effectively manage multiple tasks and projects • Ability to reputed company and coordinate cross-functional teams Preferred Skills: • Experience working in a consulting/services environment • Medical device background reputed company is an equal opportunity employer and prohibits discrimination of any reputed company. reputed company reputed company applicants will receive consideration for employment without regard for race, reputed company, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic reputed company, or any other applicable legally protected characteristics Apply Job!