What does a clinical data manager do?
A clinical data manager (CDM) manages clinical trial data collection, processing and analysis. They play a critical role in developing new medical treatments by ensuring that clinical trial data is accurate, complete and compliant with regulatory requirements.
These professionals work closely with other clinical research team members, including clinical research associates, data analysts and biostatisticians – to ensure that all aspects of the data management process are executed efficiently and accurately.
The key responsibilities of clinical data managers include designing and implementing clinical data management plans, developing data entry guidelines and standards and overseeing data quality control processes. The tasks and responsibilities of a clinical data manager are diverse and encompass various aspects of data management.
Additionally, they develop data management plans, design case report forms (CRFs) and implement electronic data capture (EDC) systems to facilitate efficient data collection. By adhering to regulatory guidelines and standard operating procedures, they ensure data integrity and compliance throughout the clinical trial lifecycle.
Clinical data managers also collaborate with study and research teams to address data-related issues promptly and generate accurate data summaries and reports for clinical study reports.
Job Description: Template
We seek an experienced clinical data manager to join our team at [Company X].
The primary responsibilities of the role will entail managing the clinical trial data of our pharmaceutical, biotechnology and medical device company.
The ideal candidate should have extensive knowledge of the clinical data management principles, regulatory guidelines and industry best practices. They should be willing to work independently and collaboratively with cross-functional teams to ensure timely and accurate data delivery.
We offer competitive compensation packages, comprehensive benefits and opportunities for growth and advancement within the company. If you are passionate about the medical field, we encourage you to apply!
Objectives of this role
- Overseeing the collection, validation and processing of clinical trial data.
- Developing and implementing data management procedures for clinical trials.
- Supporting and facilitating the review of medical coding for validity and completeness.
- Ensuring compliance with applicable regulations, protocols and standard operating procedures in India.
- Maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock.
- Stay updated on industry best practices, technological advancements and regulatory requirements related to clinical data management.
Your tasks
- Develop and maintain data management documentation, including study protocols, case report forms and data management plans.
- Design case report forms (CRFs) and electronic data capture (EDC) systems for data collection.
- Perform data entry and cleaning activities, including discrepancy management and query resolution.
- Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
- Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval.
- Collaborate with study team members to resolve data-related issues and discrepancies.
- Generate and review data listings, summaries and reports for clinical study reports.
- Serve as a primary or backup resource for issues about data management.
- Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
- Contribute to the development and validation of data management software tools.
Required skills and qualifications
- Bachelor’s degree in a scientific or healthcare-related field.
- 3-5 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry.
- Strong understanding of clinical trial processes, data management principles and regulatory guidelines.
- Proficiency in electronic data capture (EDC) systems and clinical data management software.
- Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
- Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical.
- Excellent attention to detail with problem-solving and analytical skills.
- Strong organisational and time management abilities.
Preferred skills and qualifications
- Certification in clinical data management (like CCDM).
- Knowledge of CRF design, MS Project and analytical capabilities.
- Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).
- Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
- Understanding of data privacy and protection regulations (e.g., GDPR).
- Effective communication and interpersonal skills to collaborate with other teams.
