Senior Clinical Data Manager

Katalyst CRO; New York (NY); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Data Manager to lead data management for clinical trials. This role involves developing data management plans, ensuring data quality, and collaborating with cross-functional teams to meet regulatory standards. The ideal candidate will bring at least 5 years of experience in the biopharmaceutical sector and a strong understanding of CDISC standards. Join a dynamic team where your expertise will contribute to groundbreaking research in biotechnology and healthcare. If you are passionate about data integrity and compliance, this opportunity is perfect for you.

Qualifications

• 5+ years of experience as a Clinical Data Manager in the biopharmaceutical industry.
• Familiarity with CDISC standards and knowledge of regulatory guidelines.

Responsibilities

• Develop and implement data management plans for clinical trials.
• Ensure data quality and compliance with regulatory standards.
• Oversee the collection and validation of clinical trial data.

Skills

Clinical Data Management

CDISC Standards

Statistical Analysis

Electronic Data Capture (EDC)

Regulatory Guidelines

Analytical Skills

Communication Skills

Attention to Detail

Education

Bachelor's degree in Life Science

Job description

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Responsibilities

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

Requirements

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

Additional Information

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research, Analyst, and Information Technology
• Industries: Biotechnology Research, Business Consulting and Services, Hospitals and Health Care

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