Job Description

• Independently identify, prioritize, and lead all CDM activities for assigned study.
• Represent CDM function at internal/external team calls.
• Communicate and able to provide CDM expertise for DM related activities.
• Responsible for ensuring the following activities are setup and reviewed for quality, including but not limited to.
• CDM study file setup and periodic DM reviews to ensure currency of the study file.
• Ensure proper versioning control in all DM documentation.
• CRF design, review, finalization, modifications.
• Database design, review (user acceptance testing/documentation), finalization, modifications.
• Data Management Plan review, finalization, modifications.
• Edit check specifications design, review, finalization, modifications.
• Data transfer specifications review, finalization, modifications.
• Ongoing manual data reviews and quality reviews of query process.
• Appropriately communicate data issues and ensure full execution of resolution.
• Data cleaning.
• DM listings design, review, finalization, modifications.
• Familiar with medical term coding using MedDRA, WHO Drug dictionaries.
• Data reconciliation of SAEs between the CRF and safety database.
• Data reconciliation of third-party vendor data between the CRF and third party vendor data (e.g. key header reconciliation of lab data to CRF header data).
• Understanding of internal, external data flows and ensure proper execution of data transfers per the Data Transfer Specifications.
• EDC access requests management.
• Ensure ongoing DM study metrics reporting is being communicated at team calls and outstanding items are actioned appropriately.
• End to end experience in all phases of a clinical study from a DM perspective: startup, maintenance, closeout.

Requirements:

• Bachelor's degree.
• 5-7 years of increasing DM experience in Pharmaceutical or Biotech Clinical Data Management.
• Proficient in computer technology used in an office environment (Microsoft Word, Excel, PowerPoint).
• Knowledge of the clinical trial process, ICH GCP, and applicable health authority regulations.
• Experience with Science 37 EDC platform is highly preferred, but not limiting.
• Experience with Medidata RAVE, SAS, and Coding tools.
• Strong understanding of good clinical data management and documentation practices.
• Strong attention to version and change control process.
• Awareness and familiarity of statistical methodologies and outputting (e.g. TLFs).
• Ability to solve complex problems in all areas of data management.
• Strong DM project management skills.
• Effective and professional communication skills, both verbal and written.
• Ability to work independently in a remote environment and virtual setting.
• Strong attention to detail.

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