Clinical Data Manager: Elevate Trial Data Quality

cGxPServe

Worcester (MA)

On-site

USD 65,000 - 85,000

Full time

14 days+

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Job summary

cGxPServe in Worcester, MA is seeking a Clinical Data Manager to develop and implement data management plans for clinical trials. The role focuses on ensuring data quality and integrity, and collaborating with cross-functional teams to align priorities and timelines.

You will develop and maintain study-specific data management documents, such as data management plans, annotated CRFs, and database specifications, and support QA procedures, SOPs, and regulatory compliance throughout the trial

Qualifications

Bachelor's degree in life sciences or related discipline is required.
Startup-friendly candidates with fresh experience in clinical data management are welcome.
Familiarity with ICH/GCP and FDA regulations is preferred.

Responsibilities

Develop and implement data management plans for clinical trials.
Ensure data quality and integrity throughout the trial.
Develop and maintain study data management documents such as DM plans, annotated CRFs, and database specs.
Collaborate with cross-functional teams to identify project priorities and timelines.
Manage data quality assurance procedures and perform QC checks.
Ensure adherence to regulatory guidelines and SOPs.
Contribute to developing SOPs and work instructions.
Prepare and review database validation and user acceptance testing.
Perform database lock activities, including data reconciliation and closure.