Job Description
Responsibilities: - 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.
- .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.
Job Tags
Work at office, Remote work,