ClinicalÂ DataÂ Manager

Raleigh - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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:

Bachelors 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.

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 review...

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:

Bachelors 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.