Manager, Scientific Affairs, International Medical OEM, Exciting Leadership Opportunity Hybrid

Manager, Scientific Affairs Job Category: Medical affairs & regulatory registrations Full-Time / Hybrid / Parsippany, NJ Job Details Description Essential Duties & Responsibilities Supervise staff in the completion of tasks. Develop their skills through training. Develop new employees. Maintain staff by recruiting. Ensure clinical studies are designed to validate the products intended use and meet U.S. regulatory requirements. Ensure clinical studies are conducted in compliance with current Good Clinical Practice (cGCP). Oversee site selection, contracting, budgeting and submission to the IRB for all studies Supervise and coordinate efforts for trials both within the organization and through a variety of vendors (Clinical Sites, Reference Labs, CROs etc.) as applicable Act as the primary contact between the CRO/sponsor and investigational sites (labs/clinics). Review and Approve design validation plans clinical study protocols, monitoring plans/reports site monitoring plan/report site visit reports and other study documents. site protocol deviations, adverse events forms, notes to file and other required documents for clinical studies. Conduct data reviews and prepare data summaries that support development of the clinical sections of U.S. regulatory submissions. Provide these summaries to the Regulatory Affairs team. Help to strategize and/or coordinate responses to regulatory agencies\ questions regarding the clinical study. Directly and effectively partner and collaborate with Supply Chain, Field Support, Training, Marketing, Quality and Legal to strengthen relationships and mutual trust to develop and review clinical SOPs. to develop clinical strategy for innovative technologies projects and/or products to develop and review site contracts and budgets Responsible for the Study Master File (SMF) and assure that all necessary documents are present, completed and signed before study close-out. Develop and implement metrics, policies, procedures, and protocols to ensure optimal CRA performance in line with cGCP and Good Documentation Practices (cGDP). Develop, with Director of Market Access, key metrics for staff to ensure project timeliness and manage staff adherence to timelines. Hold formal check-ins with Director of Market Access summarizing: Status of all active studies and projects Contracts / IRB / site statuses Timelines vs. plan Risks, mitigation actions, and resource needs materials needed Prepare and present reports to Director of Market Access, highlighting laboratory and CRA performance, achievements, and challenges, and making recommendations for improvement. Manage the Scientific Affairs Budget based on the payments/expenses of each individual study budget Partner and collaborate with external organizations to ensure a contemporary understanding of the industry along with technical requirements Occasionally, will be required to provide on-site support for clinical trial preparations, executions and monitoring responsibilities. Remain current with regulatory requirements, quality assurance and quality control programs via professional and educational opportunities. Continuous learning to advise the organization regarding important changes in clinical practice. Education and/or Experience A Bachelor’s degree in a relevant health-related field or scientific discipline, such as biology, chemistry, or biotechnology required. A Masters degree is preferred. Minimum of seven years clinical research related experience required. Minimum three years experience with clinical studies conducted per GCP with direct clinical site monitoring and/or clinical site management experience required. Strong background/Strong knowledge of clinical practice, safety protocols, and regulatory requirements is a must. Previous experience in a supervisory or managerial role, with a minimum of three years managing clinical study personnel is required. Knowledge of CLSI standards is a must. Proficient with MS Office suite of products. Familiarity with electronic clinical trial systems (CTMSs or EDCs). Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) desirable. Valid driver’s license and ability to travel internationally is required. Coagulation/Hematology experience preferred. Up to 20% travel required, international travel required. #J-18808-Ljbffr Jobsbl