Enable America Jobs

Remote, East Coast - USA Mission The Associate Director, Data Management will be responsible for leading the data management processes for all clinical studies at the Company. Reporting Relationship • This position reports to the Head of Biometrics or designee Duties and Responsibilities • Serve as a leader within the Clinical Development and Clinical Operations teams to help ensure that projects are completed on time, within budget, with high quality and status is transparent across the organization through proactive, effective, and timely communication. • Lead the data management partnership with Clinical Research Organizations (CROs) for all studies at the Company. Conduct oversight of CROs by ensuring data management documents and tasks are completed and delivered in accordance with timelines and data quality standards. • Act as lead clinical data manager for clinical studies performing all data management related activities. • Oversee the development of database designs, edit checks, CRF completion guidelines, data management plans and data validation plans. Develop and ensure compliance with Data Management SOPs to enable adherence to Good Clinical Practices and regulatory requirements. • Establish a governance structure with all data management and related vendors including communication and escalation pathways and agreed upon key performance indicators (KPIs). • Collaborate with internal and external functions (e.g., CROs, reading centers, software vendors, clinical development partners, etc.) to ensure that project timelines and goals are met effectively and within budget. • Provide study metrics reports to the study management teams using a variety of tracking tools to reconcile the EDC, imaging, lab and other vendor data. • Lead data review meetings to review trends in endpoint and other data variables, to identify potential safety concerns and study risks. • Support Risk-Based Quality Management (RBQM) activities in collaboration with the Clinical Operations team including input on Key Risk Indicator (KRI) development, input on design of trend/risk analysis dashboards and reports within Tableau, our integrated data visualization system. • Support Data Safety Monitoring Committee (DSMC) activities with preparation of data for presentation. • Support regulatory submissions such as DSURs to ensure timely provision of quality data. • Partner with the Company Consultants to ensure all project specific communication and exchange of information is optimized. • Attend all study team meetings to provide updates and issue resolution. • Other duties as assigned. • This job description is subject to change at any time. Educational Qualifications • Bachelor’s Degree Additional Qualifications • Bachelor’s Degree: at least six (6) years of clinical data management experience in a clinical research environment, most of which should be in industry and preferably on the sponsor side, with experience in the ophthalmology indication and EDC platforms. • Vendor management and oversight experience. • Strong technical skills across data platforms. • Experienced in designing clinical trials utilizing CDISC standards (including SDTM and standard terminology) • Cross collaboration proficiency with other departmental functions within the CRO or at the Company such as Biostatistics, Statistical Programming, Clinical Operations and Safety/Pharmacovigilance • Thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data. • Experience in regulatory GCP inspections/audits. • Outstanding verbal and written communication skills, in addition to excellent organizational skills • Ability to manage multiple projects in a fast-paced environment. • Creative, capable problem-solver. 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 requires previous supervisory experience.