Senior Clinical Data Manager (Remote)

Placements24; Soweto; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Fully remote position

Competitive compensation

Health, dental, and vision insurance

Professional development

Flexible work environment

Job summary

Placements24 is seeking a highly experienced Senior Clinical Data Manager for a fully remote position to ensure data quality and integrity across global trials. You will lead data management from database design through database lock and collaborate with biostatistics, programming and clinical operations.

The role requires deep knowledge of EDC systems (Medidata Rave, Oracle Clinical), CDISC standards and GCP compliance, with a track record of delivering complex studies remotely.

Qualifications

• Bachelor's degree in CS, statistics, life sciences or related field.
• Minimum 6 years of experience in clinical data management in pharma/biotech.
• Knowledge of EDC systems (Medidata Rave, Oracle Clinical) and CDISC standards.
• Experience leading data management activities for global trials.
• Strong understanding of GCP and data integrity requirements.
• Analytical, problem-solving and project management skills; able to manage multiple remote projects.

Responsibilities

• Oversee all data management aspects from database design to database lock.
• Develop and review data management plans (DMPs), edit checks, and data validation plans.
• Lead User Acceptance Testing (UAT) for clinical databases and data management tools.
• Ensure compliance with ICH-GCP guidelines and regulatory requirements.
• Collaborate with cross-functional teams to ensure data quality and consistency.

Skills

Clinical data management

Data integrity

Remote work management

Education

Bachelor's degree in Computer Science / Statistics / Life Sciences or related field

Tools

Medidata Rave

Oracle Clinical

CDISC

Job description

About the Role

Our client is seeking a highly experienced and meticulous Senior Clinical Data Manager for a fully remote position. This role is critical for ensuring the quality, integrity, and accuracy of clinical trial data that supports regulatory submissions and decision-making. You will lead data management activities from database design through database lock, working closely with cross-functional teams including biostatisticians, clinical programmers, and clinical operations. This is an excellent opportunity for a seasoned data manager to work independently on complex global clinical trials, contributing significantly to the success of drug development programs from a remote setting.

Key Responsibilities

• Oversee all aspects of clinical data management, including database design, data entry guidelines, data validation, and query resolution.
• Develop and review data management plans (DMPs), edit check specifications, and data validation plans.
• Lead User Acceptance Testing (UAT) for clinical databases and other data management tools.
• Ensure compliance with ICH -GCP guidelines, regulatory requirements, and company SOPs throughout the data lifecycle.
• Manage data cleaning activities and ensure timely database lock for clinical studies.
• Collaborate with clinical operations, biostatistics, and programming teams to ensure data consistency and quality.

Requirements

• Bachelor's degree in Computer Science, Statistics, Life Sciences, or a related field.
• Minimum of 6 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• In-depth knowledge of clinical trial processes, EDC systems (e.g., Medidata Rave, Oracle Clinical), and data standards (e.g., CDISC).
• Proven experience in leading data management activities for complex, global clinical trials.
• Strong understanding of GCP and regulatory requirements related to data integrity.
• Excellent analytical, problem-solving, and project management skills, with the ability to manage multiple projects simultaneously in a remote environment.

Benefits

• A competitive senior-level salary and comprehensive benefits package, including health, dental, and vision insurance.
• The significant advantage of a fully remote working arrangement, offering flexibility and work-life balance.
• Exposure to cutting-edge clinical research and the opportunity to contribute to life-saving therapies.
• Continuous learning opportunities and professional development resources.
• A collaborative and supportive virtual team environment that values expertise and contribution.