Katalyst CRO
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Clinical Data Manager
role at
Katalyst CRO .
Responsibilities
Independently identify, prioritize, and lead all CDM activities for assigned study.
Represent CDM function at internal/external team calls.
Communicate and provide CDM expertise for DM related activities.
Set up and review study files to ensure currency.
Maintain version control across all DM documentation.
Review, finalize, and modify Data Management Plan.
Review, finalize, and modify Data Transfer Specifications.
Review, finalize, and modify CRF design.
Review, finalize, and modify database design and user acceptance testing.
Review, finalize, and modify edit check specifications.
Review, finalize, and modify DM listings.
Conduct ongoing manual data reviews and query process quality reviews.
Communicate data issues and ensure resolution execution.
Perform data cleaning.
Reconcile SAEs between CRF and safety database.
Reconcile third‑party vendor data between CRF and vendor data.
Familiar with MedDRA and WHO Drug dictionaries for medical term coding.
Ensure proper execution of data transfers per the Data Transfer Specifications.
Manage EDC access requests.
Report ongoing DM study metrics in team calls and follow up on outstanding items.
End‑to‑end experience in all phases of a clinical study: start‑up, maintenance, closeout.
Requirements
Bachelor's degree.
5–7 years of increasing DM experience in pharmaceutical or biotech clinical data management.
Proficient in office technology (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.
Strong understanding of good clinical data management and documentation practices.
Strong attention to version and change control processes.
Aware of statistical methodologies and output (e.g., TLFs).
Ability to solve complex problems in all areas of data management.
Strong DM project management skills.
Effective professional communication skills, both verbal and written.
Ability to work independently in a remote environment and virtual setting.
Strong attention to detail.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology
Industries Biotechnology Research, Business Consulting and Services, and Hospitals and Health Care
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Clinical Data Manager
role at
Katalyst CRO .
Responsibilities
Independently identify, prioritize, and lead all CDM activities for assigned study.
Represent CDM function at internal/external team calls.
Communicate and provide CDM expertise for DM related activities.
Set up and review study files to ensure currency.
Maintain version control across all DM documentation.
Review, finalize, and modify Data Management Plan.
Review, finalize, and modify Data Transfer Specifications.
Review, finalize, and modify CRF design.
Review, finalize, and modify database design and user acceptance testing.
Review, finalize, and modify edit check specifications.
Review, finalize, and modify DM listings.
Conduct ongoing manual data reviews and query process quality reviews.
Communicate data issues and ensure resolution execution.
Perform data cleaning.
Reconcile SAEs between CRF and safety database.
Reconcile third‑party vendor data between CRF and vendor data.
Familiar with MedDRA and WHO Drug dictionaries for medical term coding.
Ensure proper execution of data transfers per the Data Transfer Specifications.
Manage EDC access requests.
Report ongoing DM study metrics in team calls and follow up on outstanding items.
End‑to‑end experience in all phases of a clinical study: start‑up, maintenance, closeout.
Requirements
Bachelor's degree.
5–7 years of increasing DM experience in pharmaceutical or biotech clinical data management.
Proficient in office technology (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.
Strong understanding of good clinical data management and documentation practices.
Strong attention to version and change control processes.
Aware of statistical methodologies and output (e.g., TLFs).
Ability to solve complex problems in all areas of data management.
Strong DM project management skills.
Effective professional communication skills, both verbal and written.
Ability to work independently in a remote environment and virtual setting.
Strong attention to detail.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology
Industries Biotechnology Research, Business Consulting and Services, and Hospitals and Health Care
#J-18808-Ljbffr