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Remote - East Coast, USA Mission The Senior Clinical Operations Manager provides operational leadership of clinical studies to ensure the studies are executed in accordance with the protocol, ICH/GCP guidelines, applicable regulations, and company’s policies and procedures and corporate goals. Responsibilities may include leading cross-functional study team(s) and/or the oversight of Contract Research Organizations (CRO) and vendors. The Senior Clinical Operations Manager will have a command of assigned studies, the ability to flex and adapt to dynamic situations, and will utilize critical thinking skills to facilitate risk mitigation analyses and problem solving. Reporting Relationship • The Senior Clinical Operations Manager will report to the Executive Director, Clinical Operations, or designee. Duties and Responsibilities • Lead cross-functional teams to ensure study execution within defined time, quality and cost parameters. • Develop oversight plans for outsourced activities; oversee vendors, including CROs, third-party vendors and consultants to ensure studies are effectively supported and executed within contracted terms, scope and budget. • Participate in and/or manage contract and budget negotiations with clinical sites and vendors; review and approve invoices for completed work. • Lead and/or contribute to study risk assessment and risk mitigation. Proactively communicate risks to study members and senior staff. • Facilitate and manage cross-functional interactions with internal and external stakeholders to ensure relevant and timely communication of information and materials for decision making purposes as well as ensure adherence to study timeline. • Collaborate with clinical development, data management/biostatistics, safety/pharmacovigilance, and other functions to ensure robust plans for data review. • Ensure clinical data, including vendor data, is managed, and completed in a timely manner in support of ongoing data review, interim analyses, and final database lock. • Prepare, oversee, and ensure adherence to clinical study documents such as informed consent forms, study manuals, study tools, communication plans, subject recruitment materials, etc. • Participate in the development and/or review of protocols, investigator brochures, including updates and amendments. • Review and approve corrective action plans at study sites and across study, participate in study-related audits. • Facilitate and/or conduct site qualification, initiation, engagement, co-monitoring, and close out visits, as needed. • Actively contribute to and implement best practices and standards for study management; participate in the development of initiatives and process improvement within Clinical Operations (CO); act as a role model within and beyond CO. • Approach problem solving with a strategic, action oriented and positive attitude. • Hold company goals paramount while ensuring compliance with regulations and ethical considerations. • Train team members, site staff, and vendors, as needed; appropriately delegate and oversee activities performed by junior CO team members. • Other duties as assigned. • This job description is subject to change at any time. Educational Qualifications • A bachelor’s degree (scientific discipline preferred) with at least ten (10) years of clinical research experience or medical/nursing certification with over fourteen (14) years of clinical research experience. Additional Qualifications • Twelve (12) preferred years of experience or equivalent combination of advanced degree and experience in a scientific discipline acceptable. • Three (3) years’ of Study Management experience preferred, conducting multiple clinical studies from start-up though close out. • Experience overseeing vendors, including identification and mitigation of risks. • Experience leading cross-functional teams and meetings. • In-depth understanding of ICH/GCP guidelines and FDA regulations. • Understanding/working knowledge of Microsoft Word, Excel and Microsoft Project. • Critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive study(ies) and understand implications of decisions that affect study outcomes and timelines. • Strong interpersonal and negotiation skills. • Excellent written and verbal communication skills. Physical Requirements • Physical demands: (check one) ☒ sedentary (< 10 lbs.) ☐ light work (< 20 lbs.) ☐ medium work (< 50 lbs.) ☐ heavy work (< 100 lbs.) ☐ very heavy work (>100lbs.) • Physical activity: (check all that apply) ☒repetitive motion ☐ balancing ☐stooping ☐lifting ☐climbing ☐kneeling/crouching ☐crawling ☐reaching ☒standing ☒ typing/grasping ☒walking ☐pushing/pulling ☒hearing Supervisor Responsibilities • This position does not require previous supervisory experience.