Senior Clinical Data Manager
Senior Clinical Data Manager
Posted on :
08-05-2025
Employer Active
1 Vacancy
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Job Description
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 setup/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.
- Minimum BA/BS in scientific or healthrelated field.
- Minimum of 911 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 multitask and take on new responsibilities as needed in a fastpaced 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.
Employment Type
Full Time
Key Skills
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