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Company

ClinChoice · 9 hours ago

Senior Data Manager_Remote @ US/CAN (Contract role)

United States

Contract

Remote

Senior Level, Lead/Staff

5+ years exp

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BiotechnologyConsulting

Hiring Manager

Timothy Tanaka

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Responsibilities

Act as Lead Data Manager across one or more clinical studies and lead all aspects of data management activities.

Provide expertise and oversight of all clinical database activities from design/start-up to closeout.

Reviews protocols for appropriate data capture including electronic (eCRF) design

Support CRF design, review, and validation of clinical database.

Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.

Conducts oversight of data management vendors via ongoing review of quality and performance metrics. May also conduct ongoing TMF review to ensure all data management-related documents are complete and filed.

Generates, resolves, and tracks data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications.

Facilitates and participates in datacleaning activities.

Generates and/or reviews/approves 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

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.

Qualification

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Clinical Data ManagementOncology ExperienceAuto-immune ExperienceRegulatory Guidelines KnowledgeMedidata RAVEMedidata Suite ProductsData Visualization ToolsMicrosoft OfficeTeamwork Ability

Preferred

Minimum BA/BS in scientific or health-related field.

Minimum of 5 - 7 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO.

Either oncology or auto-immune experience required.

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.

Company

ClinChoice

Glassdoor

3.7

ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide.

Founded in 1995

Shanghai, Shanghai, CHN

1001-5000 employees