Associate Director/Director Clinical Data Management

Job Description

This role will 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.

 

APPLY TO THIS POSITION


Max 1mb, accepted formats: pdf, doc, docx, rtf
Message Sent. Thank You!