What are the responsibilities and job description for the Clinical Data Manager position at Katalyst Healthcares & Life Sciences?
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 review 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
- 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.
Clinical Data Manager II
Integrated Resources INC -
Spring, PA
