Clinical Data Manager at cGxPServe Worcester, MA

cGxPServe; Worcester (MA); On-site; USD 65,000 - 85,000; Full time

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.

Skills

Strong analytical and problem-solving

Attention to detail

Interpersonal and communication

Education

Bachelor's degree in life sciences or related discipline

Job description

Overview

Clinical Data Manager job at cGxPServe. Worcester, MA.

Responsibilities

• Develop and implement data management plans for clinical trials.
• Ensure data quality and integrity throughout the trial.
• Develop and maintain study-specific data management documents such as data management plans, annotated CRFs, and database specifications.
• Collaborate with cross-functional teams to identify project priorities and timelines.
• Manage data quality assurance procedures and perform quality control checks.
• Ensure adherence to regulatory compliance by following relevant guidelines and standard procedures.
• Contribute to the development of standard operating procedures (SOPs) and work instructions.
• Prepare and review database validation and user acceptance testing.
• Perform database lock activities, including data reconciliation and database closure.

Requirements

• Bachelor\'s degree in a relevant field such as life sciences or a related discipline.
• Freshers in clinical data management of drug development programs.
• Familiarity with regulatory guidelines such as ICH/GCP and FDA regulations.
• Strong analytical and problem-solving skills.
• Excellent attention to detail and organization skills.
• Good interpersonal and communication skills to work effectively in a team environment.