Clinical Data Manager

Title: Clinical Data Manager – External Data Reconciliation

Location: Redwood City, CA (Hybrid – 2–3 days onsite)

* Must be local

Duration: 6 months - 1 year (to start - extensions possible)

Pay: Up to ~$90/hr

* Skills, experience, and other compensable factors will be taken into account when determining pay rate. The pay range provided in this posting is a reflection of a W2 hourly rate.

We are seeking an experienced Clinical Data Manager with strong expertise in external vendor data reconciliation to support ongoing clinical studies for a biotechnology client located in Redwood City, CA. This role will work cross-functionally with internal teams and external vendors to ensure the quality, accuracy, and completeness of clinical trial data.

This is a hybrid position requiring 2–3 days onsite per week.

• Coordinate with external vendors, CROs, and internal study teams to manage data transfer agreements and specifications.
• Reconcile and review external clinical data including:
• Safety laboratory data
• PK (pharmacokinetic) data
• ECG data
• Perform Serious Adverse Event (SAE) reconciliation in collaboration with Safety/Pharmacovigilance teams according to SOPs and regulatory requirements.
• Review local laboratory data and normal ranges
  , identifying missing data, inconsistencies, or abnormal units.
• Communicate data discrepancies and validation issues with Data Management vendors, CRO partners, and internal teams
  .
• Maintain data transfer agreements, reconciliation trackers, and issue logs
  .
• Review external data listings and issue queries or follow up with vendors as needed.
• Contribute to Data Management Plans (DMP) and ensure external data handling processes are properly documented.
• Support study start-up activities
  , including external vendor data set-up and data transfer validation.
• Perform QC of external data test transfers to ensure proper integration into study databases.
• Provide data metrics, reconciliation summaries, and issue tracking to study teams.
• Participate in cross-functional study team meetings and communicate data risks or trends.
• Identify opportunities for process improvements in external data handling and reconciliation workflows
  .

• 5+ years of Clinical Data Management experience in biotech, pharma, or CRO environments.
• Strong experience with external vendor data reconciliation in clinical trials.
• Experience reconciling clinical data from sources such as:
• Central laboratories
• Familiarity with local laboratory ranges, units, and lab data review
  .
• Experience working with cross-functional stakeholders including Clinical Operations, Safety/Pharmacovigilance, Biostatistics, and Medical teams
  .
• Experience supporting SAE reconciliation processes.
• Strong understanding of EDC systems and clinical data workflows
  .
• Excellent communication skills and ability to troubleshoot data issues with internal and external teams.

• Experience working with RECIST/BICR imaging data
• Exposure to PK or biomarker data reconciliation
• Experience in biotech or early-phase clinical trials