Position:Clinical Data Manager
Location:Palo Alto, CA (Hybrid - 3 days onsite)
Length:12+ months
*W2 Candidates Only, No C2C
Job Description:
Our client is seeking an experienced Clinical Data Manager to support clinical trials involving In Vitro Diagnostics (IVDs). This role is critical in ensuring integrity, accuracy, and compliance of clinical data across multiple platforms and stakeholders. The ideal candidate has hands-on experience managing data across the full clinical trial lifecycle and is comfortable working in a regulated, cross-functional environment.
Essential Duties and Responsibilities (but not limited to):
- Ensure accuracy, completeness, and consistency of clinical trial data captured through CRFs, EDC systems, CTMS, imaging platforms, and other digital tools.
- Independently implement and maintain robust processes to uphold data quality, integrity, and safety across all phases of the trial.
- Lead data review activities, including query generation, resolution tracking, and ongoing data cleaning.
- Oversee sample and data reconciliation across internal systems, central labs, and external vendors.
- Act as the primary point of contact for all data-related matters across clinical operations, regulatory, biostatistics, and safety teams.
- Coordinate with cross-functional stakeholders to ensure data readiness for interim analyses, publications, and regulatory filings.
- Design and maintain CRFs and associated metadata (i.e., edit checks, derivations) align with IVD-specific protocols.
- Support the creation of the Data Management Plan (DMP), Case Completion Guidelines (CCG), and Data Transfer Specifications.
- Develop and manage SOPs and work instructions specific to IVD data management.
- Ensure all practices align with GCP, FDA regulations, and ISO 13485 quality standards.
- Oversee proper document filing and version control in the eTMF to ensure audit readiness.
- Ensure timely upload and quality review of essential documents per the TMF Reference Model.
- Lead system validation and QC processes for document sharing tools (i.e., SharePoint, Box, Google Drive).
- Serve as system administrator for platform access, permissions, and role-based controls.
- Ensure secure handling and storage of clinical data and associated metadata.
- Develop and manage data workflows that support study reports, conference abstracts, and peer-reviewed publications.
Qualifications:
- Bachelor's degree in Life Sciences, Data Management, or related field (Master's degree is preferred).
- Minimum of 5 years of experience in clinical data management, with a strong emphasis on in-house study execution.
- Proven ability to independently build and maintain internal infrastructure for data review, document management, and cross-functional collaboration with minimal oversight.
- Strong background in in-house clinical data management, with experience primarily focused on internal study execution and minimal reliance on CRO-managed trials.
- Deep understanding of IVD or diagnostics studies, and familiarity with clinical trial data across EDC, CTMS, and associated platforms.
- Strong working knowledge of GCP, FDA regulations, and ISO 13485 quality standards.
- Proficient in document management systems (i.e., SharePoint, Box, Google Drive) and experience managing system access and controls.
- Excellent organizational, analytical, and communication skills; able to operate effectively in fast-paced, cross-functional environments.
- Pay range $140,000 - $170,000 depending on experience.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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Digital Prospectors
Jul 03, 2025