Remote Senior Clinical Data Manager

Placements24; Durban; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Fully remote

Bonuses

Health benefits

Paid time off

Remote stipend

Professional development

Job summary

Placements24 is seeking a Senior Clinical Data Manager to lead data management across clinical trials in a fully remote role within South Africa. You will design, validate, and manage EDC systems (Medidata Rave, Oracle Clinical, Veeva), implement CDISC SDTM/ADaM standards, and ensure GCP compliance from start-up through database lock.

The ideal candidate has 6+ years of clinical data management experience, strong analytical skills, and the ability to mentor junior staff in a remote team

Qualifications

• Bachelor's degree in a scientific, technical, or healthcare-related field.
• 6+ years of progressive clinical data management experience.
• Proficiency in EDC systems (Medidata Rave, Oracle Clinical, Veeva).
• Strong understanding of CDISC standards (SDTM, ADaM) and their application in clinical data management.
• Experience in developing DMPs, CRFs, and data validation plans.
• In-depth knowledge of GCP and regulatory requirements.

Responsibilities

• Oversee data management for assigned trials from start-up to database lock.
• Design, build, and validate clinical databases and EDC systems.
• Define data validation rules and edit checks to ensure accuracy.
• Manage data cleaning, queries, resolution, and reconciliation.
• Mentor junior data management staff and provide guidance.
• Ensure compliance with protocols and regulatory guidelines (GCP, CDISC).
• Oversee database lock procedures and archival of study data.

Skills

EDC systems

CDISC (SDTM/ADaM)

SQL

SAS

GCP compliance

Education

Bachelor's degree in a scientific/technical/healthcare field

Tools

Medidata Rave

Oracle Clinical

Veeva

Job description

About the Role

Our client, a pioneering global biopharmaceutical company, is seeking a highly skilled and experienced Senior Clinical Data Manager to join their expanding team. This is a fully remote position, offering the flexibility to work from anywhere within South Africa. You will play a crucial role in ensuring the integrity, quality, and accuracy of clinical trial data that supports critical regulatory submissions and drug development programs. This role is integral to the success of our client's research efforts, providing essential data management expertise from study start-up through to database lock and archiving. The ideal candidate will possess a strong understanding of clinical trial processes, data management standards, and regulatory requirements, coupled with excellent technical proficiency. This remote-first opportunity is perfect for a driven individual looking to contribute to groundbreaking medical advancements while enjoying the benefits of remote work.

Key Responsibilities

• Oversee and manage all aspects of clinical data management for assigned clinical trials.
• Develop and maintain Data Management Plans (DMPs) in collaboration with clinical study teams.
• Design, build, and validate clinical databases and electronic data capture (EDC) systems.
• Define data validation rules and develop edit checks to ensure data accuracy and completeness.
• Manage data cleaning activities, including query generation, resolution, and reconciliation.
• Perform data reviews and ensure compliance with protocols, SOPs, and regulatory guidelines (e.g., GCP, CDISC).
• Oversee database lock procedures and ensure timely archival of study data.
• Contribute to the selection and implementation of data management tools and technologies.
• Provide technical guidance and mentorship to junior data management staff.

Requirements

• Bachelor's degree in a scientific, technical, or healthcare-related field.
• Minimum of 6 years of progressive experience in clinical data management in the pharmaceutical or biotech industry.
• Proficiency in EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva) and data management software.
• Strong understanding of CDISC standards (SDTM, ADaM) and their application in clinical data management.
• Demonstrated experience in developing DMPs, CRFs, and data validation plans.
• In-depth knowledge of Good Clinical Practice (GCP) and other relevant regulatory requirements.
• Excellent analytical and problem-solving skills with a keen attention to detail.
• Effective communication and interpersonal skills, with the ability to work collaboratively in a remote team environment.
• Experience with programming languages (e.g., SQL, SAS) for data analysis and validation is a significant advantage.

Benefits

• Fully remote work arrangement with flexible hours.
• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits package.
• Generous paid time off and remote work stipends.
• Opportunities for professional growth, training, and certifications.
• Contribution towards home office setup.
• Involvement in groundbreaking clinical research that impacts global health.