Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Support the Lead Data Manager across one or more clinical studies.
Reviews protocols for appropriate data capture including electronic (eCRF) design.
Support CRF design, review, and validation of clinical database.
Provide expertise and support oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
Reviews or generates study documents (Data Management Plan, CRF Completion Guidelines, DB build specifications, Edit Check Specifications, Data Transfer Specifications, SAE and/or External Data Reconciliation Plans, Coding Guidelines, Vendor Management Plans, etc.).
Review CRF metrics reports against project data deliverables.
Conducts oversight of data management vendors via ongoing review of quality and performance metrics.
Leads the Data Review plan check, specification and validation updates.
Facilitates and participates in scheduled and ad hoc data listing review.
Generates, resolves, and tracks data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications.
Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
Reviews and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.
Maintains study DM related documents/files for inspection readiness.
Conducts the SAE and external vendor data reconciliation.
Review and may distribute/coordinate data management metrics, listings, and reports.
Responsible for maintaining internal data management timelines and metrics. Maintains study DM related documents/files for inspection readiness.
Proactively identifies potential data management issues/risks and communicates it within the study team for further action.
Participate in process improvement activities resulting in increases in productivity, quality, and/or cost effectiveness.
Requirements:
Minimum BA/BS in scientific or health-related field.
Minimum of 9-11 years of clinical data management experience in the pharmaceutical, and biotechnology industry or in a CRO.
At least 1 year experience working at a Sponsor.
Oncology trial experience required, hematology/oncology preferred.
Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to DM practice.
Proficient with Medidata RAVE.
Experience with working on Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
Familiarity with various data visualization, analytics, and reporting tools is a plus
Excellent communication skills (verbal and writing).
Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting.
Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.)
Strong organizational skills and ability to prioritize tasks.
Proven ability to work independently and in a team setting.