Senior Clinical Data Manager

About the position

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Responsibilities

• Develop and implement data management plans and procedures for clinical trials.
• Oversee the collection and validation of clinical trial data.
• Ensure data quality and accuracy through data review, query resolution, and data cleaning.
• Work with cross-functional teams, including biostatistics, clinical operations, and medical writing.
• Ensure compliance with regulatory and industry standards.
• Participate in the development of clinical study protocols and case report forms.
• Manage data transfer and reconciliation between different systems.
• Generate study-specific data management reports.
• Provide input into the development of project timelines and resource planning.
• Maintain knowledge of relevant industry and regulatory guidelines.
• Develop and maintain data management standards and best practices.

Requirements

• Bachelor's degree in life science or related field.
• Minimum of 5 years of experience as a Clinical Data Manager in the biopharmaceutical industry.
• Familiarity with CDISC standards and guidelines.
• Knowledge of clinical trial design and statistical analysis.
• Experience with Electronic Data Capture (EDC) systems.
• Knowledge of regulatory guidelines, including FDA and ICH guidelines.
• Excellent analytical and problem-solving skills.
• Strong written and verbal communication skills.
• Ability to work independently as well as in a team environment.
• Strong attention to detail and accuracy.