Dova is currently recruiting a Manager, Data Management to join our Biostatistics team in our Durham, NC office, reporting to the Senior Director, Biostatistics. In the role of Manager, Data Management, you will be responsible for performing various activities to support the clinical operations team, including ensuring data management activities for clinical trials are completed in a timely and accurate manner, and by providing oversight/guidance of CROs performing core data management functions.
To be successful in this role, you must have strong time management skills, be effective at multitasking, and able to successfully manage time sensitive demands, incomplete information or unexpected events.
• Accountable for overseeing data integrity, quality, and consistency at database lock.
• Participate in developing/reviewing clinical trial and data management documents, such as protocols, CRFs, edit checks, data management plans.
• Participate in data management activities, such as EDC and IWRS user acceptance testing, data cleaning, data quality review, identification of data discrepancies, and database lock process.
• Ensure clinical trial data and data system compliance with regulatory requirements and standards; use and enforce CDISC STDM standards.
• In collaboration with statisticians, prepare datasets for ad hoc in-house analyses and abstract submissions including merging datasets from various sources to create required data cuts as needed.
• Ensure complete and consistent medical term coding using appropriate dictionaries.
• Ensure consistency of SAE data fields and content across study and PVG databases.
• Contribute to the compilation and review of datasets which will support submissions to regulatory authorities such as in IND filings, IND annual reports/DSURs, NDAs.
• Support overall corporate goals by meeting or exceeding metrics for study timelines and project deliverables.
• Develop SOPs for Data Management function.
• Evaluate/qualify data management CROs by providing technical review and input on scope of work and bid proposals.
• Contribute to development of outsourcing strategies and relationships with outsourcing partners or CROs.
• Other duties as assigned.
• BS in life sciences or related fields and at least five (5) years relevant work experience in data management including function as a Data Management Lead in Phase 1-4 clinical trials.
• Thorough understanding of cross-functional processes impacting clinical data management; In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
• Experience in CRF development, database design, EDC systems, data management systems, data management plans, data cleaning, and implementation of CDISC standards.
• Experience in coordinating activities such as medical coding, electronic data transfers, and all other aspects of data clean-up.
• Working knowledge of GCP and regulatory requirements as they relate to data management systems and activities.
• Proficiently use SAS to review and work with clinical datasets.
• Ability to work on multiple projects and exercise independent judgment within generally defined practices and policies leading to obtaining results.
• Strong attention to detail and excellent organization skills.
• Strong interpersonal skills and communication skills (both written and oral).
• Ability to work effectively in a fast-paced environment (interpersonal, relationship management) with study teams, cross-functional team members and external partners/vendors.
Why Join Us?
With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. At our Durham office, we provide a sleek and high-tech work environment with glass walls and adjustable desks. All employees are issued laptops, have access to a stocked kitchen, and are included in Free Lunch Fridays! We also offer a competitive benefits package, to support the health and happiness of our staff.