Clinical Data Manager (Remote)

Placements24; United States; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Remote-first culture

Home office equipment

Paid time off

Training & certifications

Retirement plan

Job summary

Placements24 is seeking a meticulous Clinical Data Manager for a fully remote role supporting oncology trials. You will oversee the data lifecycle from database design to database lock, ensuring accuracy, integrity, and completeness of trial data from home.

The role emphasizes collaboration with biostatistics and operations, adherence to ICH-GCP and CDISC standards, and ongoing evaluation of new data management technologies. A strong background in EDC systems and CDISC is required.

Qualifications

• Bachelor's degree in a scientific or healthcare field is required.
• At least 5 years of clinical data management experience in pharma/biotech.
• Experience with EDC systems (Medidata Rave, Oracle Clinical, Veeva) and data cleaning.
• Strong knowledge of CDISC SDTM and ADaM standards.
• Familiarity with ICH-GCP guidelines and data management best practices.
• Excellent communication and ability to work remotely.

Responsibilities

• Oversee design, development, and validation of clinical databases (EDC).
• Develop and maintain the Data Management Plan (DMP).
• Perform data validation, identify discrepancies, create data queries.
• Manage data cleaning and respond to site queries.
• Execute database lock procedures per timelines and quality standards.
• Ensure compliance with ICH-GCP, CDISC SDTM/ADaM and regulatory requirements.
• Collaborate with biostatisticians to define data analysis needs.
• Participate in study team meetings and data management planning.
• Maintain documentation for all data management activities.
• Assist in evaluating new data management technologies.

Skills

Data validation

Attention to detail

Remote work collaboration

Analytical thinking

Education

Bachelor's degree in science/healthcare

Tools

Medidata Rave

Oracle Clinical

Veeva Systems

SQL

Job description

About the Role

Our client, a rapidly expanding clinical research organization specializing in oncology trials, is seeking a meticulous and experienced Clinical Data Manager to join their fully remote team. This role is integral to ensuring the accuracy, integrity, and completeness of clinical trial data, which is fundamental to the success of our research endeavors. You will be responsible for managing the entire data lifecycle, from database design and setup to data cleaning and database lock. This position offers the exciting opportunity to work on groundbreaking therapies from the comfort of your home office, contributing to significant advancements in cancer treatment. The Welkom, Free State, ZA location serves as a nominal point of reference for this fully remote role, emphasizing our commitment to providing flexible work arrangements for our talented professionals.

Key Responsibilities

• Oversee the design, development, and validation of clinical databases (e.g., EDC systems) in collaboration with clinical operations and biostatistics teams.
• Develop and maintain the Data Management Plan (DMP), ensuring it aligns with the protocol and relevant standards.
• Perform data validation checks, identify data discrepancies, and generate data queries for resolution by clinical sites.
• Manage data cleaning activities, review query responses, and ensure timely resolution of all data issues.
• Execute database lock procedures according to established timelines and quality standards.
• Ensure compliance with ICH-GCP guidelines, CDISC standards (SDTM, ADaM), and all applicable regulatory requirements.
• Collaborate with biostatisticians and statistical programmers to define data analysis requirements and prepare datasets for analysis.
• Participate in study team meetings and contribute to the data management aspects of clinical trial planning and execution.
• Maintain accurate and comprehensive documentation for all data management activities.
• Assist in the selection and implementation of new data management technologies and tools.

Requirements

• Bachelor's degree in a scientific or healthcare-related field (e.g., Statistics, Computer Science, Biology, Nursing).
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and data management best practices.
• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, Veeva) and data cleaning tools.
• Understanding of CDISC data standards (SDTM, ADaM).
• Strong analytical and problem-solving skills, with excellent attention to detail.
• Effective communication and interpersonal skills, with the ability to work collaboratively in a remote environment.
• Experience in oncology clinical trials is highly desirable.
• Ability to manage multiple projects and meet strict deadlines.
• Familiarity with database programming and SQL is a plus.

Benefits

• Competitive salary commensurate with experience and fully remote status.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and company holidays.
• Opportunities for professional growth and development, including training and certifications.
• Exposure to innovative clinical trials and cutting-edge therapeutic areas.
• A supportive and collaborative remote-first work culture.
• Contribution to the development of life-saving treatments.
• Company-provided home office equipment and support.
• Retirement savings plan with employer contributions.