Associate Director, Data Management
FHI 360, Durham NC, United States
Closing Date for Applications:
Oversees the daily activities of the Data Management department. Supports clinical and social research programs by providing database design, database management training, customized clinical site tool development and overall data management study support. Serves as the technical lead for all data management activities for assigned projects that have been contracted with contract research organizations, as well as internal projects. Lead data management activities for complex global studies (multi-country, multi-site trials) possibly using regional data entry centers external to FHI 360.
- Provides data management (DM) expertise and guidance to the project team regarding the data management DM activities and deliverables
- Establishes Data Management strategy at the project and/or study level.
- Ensures data management deliverables for all studies within the project/program level meets quality, time and cost effective
- Leads functional and/or multidisciplinary teams working on projects/studies and/or initiatives.
- Leads and manages the standardized Data Management Process and Procedures for consistency across programs and organization
- Plans and directs the conduct of Data Management activities for assigned projects/studies (e.g., study startup, study conduct, study closeout, and reporting).
- Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable FHI 360 and regulatory requirements.
- Reviews/approves clinical study-related documents that are owned by other functions (e.g., Protocols, Statistical Analysis Plans, Clinical Study Reports).
- Actively participates in audits and inspections.
- Proactively drives project success, including working closely with clinical project managers to develop and implement clinical data management processes and related technology.
- Provides oversight of compliance of clinical database systems and processes associated with The Code of Federal Regulations (21CFR Part 11) requirements, in accordance with the International Conference on Harmonization (ICH)/Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA) guidelines, and current Federal Regulations.
- Leads and/or supports data -related, technology-based initiatives such as ePRO, eSource and custom applications.
- Contributes to back-end project budget/resource planning, along with Clinical Project Managers (CPMs) and Clinical Operations management.
- Directs people management responsibilities including performance evaluations, goal setting, career development, and departmental growth.
- Serves as primary communication point for project teams and company departments regarding clinical data management role for complex research studies.
- Ensures timeliness of deliverables for assigned study, from study start-up through production and close-out activities.
- Interacts with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Project Management, Safety, Medical Coding, site personnel to implement process improvement measures within data management on both departmental and project level.
- Leads development of Data Validation Plan/Edit Check Specifications.
- Participates in study/project team meetings as primary data management representative providing written project status reports and updates on study status.
- Coordinates with Study Team to identify issues/trends for discussion.
- Delegates specific data management tasks for assigned protocol(s) to data management programming staff
- Develops key protocol study documents such as Care Report Form (CRF) completion guidelines, Data Management Plan, Database Validation Plan, Data Management Quality Plan, etc.
- Provides project-specific data management training for study investigators and clinical team in CRF completion and data management processes.
Applied Knowledge & Skills:
- In-depth knowledge of clinical data management processes and requirements, including, but not limited to 21CFR Part 11 and regulated systems.
- Proven experience in use of CDISC and SDTM standards and deliverables.
- Proven experience in data programming and data design. MS SQL a plus.
- Experience leading multiple studies at once from start-up to lock.
- Experience leading global clinical trials data management. Developing world experience a requirement.
- Extensive knowledge of international clinical research regulatory guidance documents and regulations.
- Able to work closely with clients to understand and operationalize their needs and study budgets.
- Able to plan and organize efficiently by adhering to existing processes and procedures and by maximizing the use of available internal and external resources.
- Demonstrates strong knowledge of computerized information systems (EDC) and standard application software (Windows, MS Office).
- Proven experience in effective study management, risk mitigation and change management.
- Proven ability to manage a cross functional data management team.
- Ability to write reports, business correspondence, and procedural manuals.
- Excellent communication skills, including effectively presenting information and responding to questions from project teams, external vendors and clients.
- Ability to ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.
- Excellent quantitative and analytical skills.
- Well-developed oral and written communication skills.
- Exhibits an open and constructive communication style.
- Ability to work on multiple projects at the same time.
- Manages the execution of the strategy of the function or sub-function through a group of subordinate managers, supervisors or individual contributors.
- Coordinates resources for ongoing projects across business groups and addresses/resolves program issues.
- Sets goals and budgets for department.
- Typically reports to a Director.
Problem Solving & Impact:
- Proactively identifies and manages risks at the project and/or study level for a larger number of projects/studies with greater complexity.
- Demonstrates good judgment, strong analytical thinking and problem solving and can differentiate between critical and non-critical issues to manage appropriately.
- Demonstrates good time management, critical thinking, and decision-making.
- Demonstrates a results-orientated, accountable, flexible approach to problem solving.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Decisions may affect a work unit or area within a department.
- Bachelor’s Degree or its International Equivalent in Computer Programming, Data Analytics, Global Health, Clinical Trials, Sciences or Related Field, preferred or equivalent related education and experience.
- Master’s Degree preferred.
- Typically requires 10+ years of experience in clinical trials data management gained in a CRO, Pharmaceutical, Health services, Non-profit NGO or Biotechnology company.
- International experience with a broad range of clinical trials (Phase I-IV) and epidemiology clinical research studies.
- Documented experience of operating in a resource constrained work environment.
- Experience in creating and managing budgets.
- Demonstrated project and operational management and leadership skills (e.g. managing cross functional international teams).
- Experience using OpenClinica, REDCap, a plus.
- Experience working with Vaccine or Infectious Disease areas a plus.