Senior Clinical Data Manager
Company Description
- 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.
Job Description
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.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Average salary estimate
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