Clinical Data Manager

Katalyst HealthCares and Life Sciences • Full-time • Worcester, MA, US • $70k - $95k / year • 1m ago

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.