Associate Director/Director Clinical Data Management

Job Description

In this role you will be responsible for the oversight of Clinical Data Management activities for all ongoing and planned clinical trials. The applicant must possess a thorough understanding of electronic data capture systems and infrastructure-related projects. The applicant will collaborate with cross-functional groups within the company and provide oversight of CDM activities lead by a CRO. This position reports to the CMO.

  • Provides a high level of expertise in data management to support clinical systems including EDC and Clinical Programming
  • Lead Clinical Data Standards development and governance
  • A subject matter expert in CDM, CDISC (CDASH)
  • Lead Continuous Process Improvement initiatives in CDM
  • Manage relationships with CDM Systems vendors
  • Effectively manages Clinical Research Organizations (CROs) to ensure high-quality deliverables within timeline and budget
  • Manages time and resource constraints across multiple projects
  • Contributes to the development and implementation of new or improved processes for data management
  • Develops and implement training curriculum for data management activities and principles as required
  • Develop or oversight of CRFs and annotations
  • Develop or oversight development of clinical database
  • Work with stakeholders for developing the required database specifications
  • Stays abreast of all requirements of EDC and electronic submission
  • Utilizes EDC platforms such as RAVE, Data Track, Tempo etc.
  • Writing Edit Checks, implement and test user requirement testing/UAT, and documentation
  • Continued query management and providing metrics to the team for assessing the health of data collection and cleaning
  • A very clear and hands on experience with various database systems and electronic data capture
  • Superb understanding of relational database and ability to function individually as well as a member of a team
  • Strong understanding of clinical trials and regulated and GCP compliant working environment and documentation
  • Lead implementation team(s) appropriately and develop, implement, and version data standards. MedDRA and WHO-DD Coding – Implement centralized dictionary coding and dictionary versioning
  • Electronic Data Capture, Medidata/RAVE – Implement screen/system development; expertise on underlying data structure and data storage; manage technical system problems and take corrective action; support ad-hoc report development
  • CDASH – Implement and perform versioning; develop global standard CDASH case report form library and code lists; implement in EDC
  • Laboratory data standardization and collection – Define global laboratory standards library and reports; perform laboratory data review, standardization, identify data discrepancies and corresponding resolutions
  • Lead the clinical project team to develop eCRF according to CDASH for clinical trials
  • May directly or indirectly supervise employee (s) through a dotted line structure or via other subordinate supervisors

Job Requirements

  • Bachelor’s degree or above in a biomedical or computer science discipline or equivalent experience is required
  • Experience leading and working in Biotech/Pharmaceutical industry required
  • Demonstrated experience leading data management teams is required
  • Experience leading or supporting regulatory submissions or inspections is required
  • Previous experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
  • Experience must include strong working knowledge of data management practices; strong expertise in data capture; knowledge of SDTM models and experience in transforming raw data into approved standards; and familiarity with applicable US and global regulatory requirements. Skills in programming and generation of data listings and summary tables using SAS and other languages would be helpful
  • Excellent communication and presentation skill
  • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways
  • Develops technical and/or business solutions to complex problems
  • Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results
  • Guides the successful completion of major programs, projects and/or functions
  • Ability to manage clinical projects with minimum supervision
  • This role requires up to 20% travel in support of clinical study activities
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