Clinical Data Manager

A Clinical Data Manager (CDM) is a critical role in the field of clinical research, responsible for overseeing the collection, management, and quality control of clinical trial data. This role ensures that data collected during clinical trials is accurate, complete, and compliant with regulatory standards.

Key Roles and Responsibilities of a Clinical Data Manager:

1. Study Design and Planning Collaborate with clinical research teams to define data collection requirements and create data management plans. Develop and implement case report forms (CRFs) for the collection of clinical data. Determine database structure, layout, and the overall system for data storage.
2. Data Collection Oversight: Oversee the collection of clinical trial data from various sources (e.g., CRFs, electronic health records, and laboratory data) Ensure accurate and consistent data entry throughout the study. Monitor data for completeness, timeliness, and accuracy.
3. Data Validation and Cleaning: Identify, track, and resolve discrepancies or inconsistencies in the clinical data. Perform data validation processes to ensure the accuracy and integrity of the data Use automated tools or manual methods to perform data cleaning, ensuring all data is complete, correct, and consistent.
4. Database Management:

• Oversee the design, setup, and maintenance of clinical trial databases (e.g., Electronic Data Capture, or EDC systems).
• Ensure the proper structure and format of databases to facilitate easy access, management, and analysis.
• Ensure the integrity of the data through backup, security, and disaster recovery measures.

1. Data Quality Assurance and Compliance:

• Ensure data meets industry regulations, such as Good Clinical Practice (GCP), FDA, ICH, and other relevant standards.
• Conduct regular audits and quality checks to ensure compliance with regulatory and ethical guidelines.
• Ensure that data management processes comply with privacy regulations (e.g., HIPAA).

1. Reporting and Documentation:

• Generate reports on data quality, discrepancies, and trends for internal and external stakeholders.
• Document all data management activities, including changes to databases, validation results, and data handling procedures.
• Prepare data for statistical analysis and final reports for regulatory submissions.

1. Collaboration and Communication:

• Work closely with clinical research associates (CRAs), statisticians, and project managers to ensure proper data management throughout the clinical trial.
• Communicate regularly with cross-functional teams (clinical, regulatory, data management) to resolve data issues or concerns.
• Participate in meetings and contribute insights regarding data management challenges or improvements.

1. Training and Support: Train clinical and site personnel on proper data entry procedures and the use of data management systems. Provide ongoing support to data entry teams and clinical staff to ensure consistency and accuracy in data handling.
2. Adverse Event Reporting: Monitor and manage adverse event data, ensuring accurate reporting according to regulatory requirements. Ensure timely and appropriate resolution of adverse event data discrepancies.
3. Database Lock and Finalization:

• Oversee the final review and "lock" of the database after all data discrepancies have been resolved and the dataset is complete.
• Ensure that the final dataset is prepared and submitted for statistical analysis, regulatory review, and publication.

Skills and Qualifications:

• Education: Typically, a degree in life sciences, nursing, medical technology, or related fields. A background in statistics or data science is a plus.
• Experience: Previous experience in clinical data management or clinical research.
• Technical Skills: Proficiency with data management software (e.g., EDC systems like Medidata Rave, Oracle, or SAS) and data cleaning tools.
• Knowledge: Familiarity with GCP, ICH guidelines, regulatory standards, and clinical trial processes.
• Attention to Detail: Ability to identify inconsistencies or errors in complex data sets.
• Communication Skills: Ability to work with cross-functional teams and effectively communicate issues, requirements, and solutions.

Clinical Data Managers play an essential role in ensuring the success of clinical trials by managing the integrity and compliance of the data, ultimately supporting the development of new treatments and drugs.

About Us:

Ascendion is a global, leading provider of AI-first software engineering services, delivering transformative solutions across North America, APAC, and Europe. We are headquartered in New Jersey. We combine technology and talent to deliver tech debt relief, improve engineering productivity solutions, and accelerate time to value, driving our clients’ digital journeys with efficiency and velocity. Guided by our “Engineering to the power of AI” [EngineeringAI] methodology, we integrate AI into software engineering, enterprise operations, and talent orchestration, to address critical challenges of trust, speed, and capital. For more information, please go to www.ascendion.com

With Ascendion (www.ascendion.com), you:

• Will get to work on numerous challenging and exciting projects on our various offerings including Salesforce, AI/Data Science, Generative AI/ML, Automation, Cloud Enterprise and Product/Platform Engineering.
• At Ascendion you have high chances of project extension or redeployment to other clients.
• Additionally, you can also share CV of anyone you know. We have a referral policy in place.