Senior Data Manager, Clinical Trials

Placements24; LegKraal Gate; Hybrid; ZAR 1,469,000 - 2,122,000; Full time

Benefits offered by this job

Bonus program

Remote work setup with equipment

Health/dental/vision insurance

Generous paid time off

Job summary

Placements24's client is seeking a Senior Data Manager to lead end-to-end clinical data management for globally distributed trials in a fully remote role. You will design databases, implement CDISC SDTM/ADaM standards, create DMPs/DVPs, oversee data cleaning, and ensure GCP compliance across the data lifecycle.

The role emphasizes mentoring junior data managers, collaborating with international teams, and delivering high-quality data to support life-saving therapies.

Qualifications

• Bachelor's degree in a scientific or technical field; Master's preferred.
• Minimum 7 years of clinical data management experience in pharma/biotech.
• Extensive EDC experience (Medidata Rave, Oracle Clinical) and SQL proficiency.
• Strong CDISC SDTM/ADaM knowledge and regulatory familiarity.

Responsibilities

• Oversee design, development, and validation of clinical databases per study protocols.
• Develop and execute data management plans (DMPs) and validation plans (DVPs).
• Manage data cleaning, queries, resolution, and reconciliation.
• Ensure GCP compliance and adherence to SOPs across the data lifecycle.
• Lead and mentor junior data managers to improve processes.

Skills

CDISC standards

SQL

EDC systems

GCP compliance

Remote collaboration

Education

Bachelor's degree in a relevant field

Master's degree preferred

Tools

Medidata Rave

Oracle Clinical

Job description

About the Role

Our client, a leading pharmaceutical innovator, is seeking a highly experienced Senior Data Manager to join their globally distributed clinical operations team. This is a fully remote position, requiring exceptional organizational skills and a deep understanding of clinical trial data management processes. You will be responsible for the end-to-end management of clinical trial data, ensuring its accuracy, completeness, and integrity from database design through database lock. This pivotal role will support the development of life-saving therapies and requires a proactive approach to data quality and regulatory compliance. You will work with cutting-edge technology and collaborate with international teams in this crucial role.

Key Responsibilities

• Oversee the design, development, and validation of clinical databases in accordance with study protocols and CDISC standards.
• Develop and execute data management plans (DMPs) and data validation plans (DVPs).
• Manage data cleaning activities, including query generation, resolution, and reconciliation processes.
• Ensure compliance with GCP, regulatory requirements, and internal SOPs throughout the data lifecycle.
• Lead and mentor junior data managers, contributing to the continuous improvement of data management processes across the organization.

Requirements

• Bachelor's degree in a relevant scientific or technical field; Master's degree preferred.
• Minimum of 7 years of experience in clinical data management within the pharmaceutical/biotech industry.
• Extensive experience with EDC systems (e.g., Medidata Rave, Oracle Clinical) and proficiency in SQL.
• Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory guidelines.
• Exceptional attention to detail, problem-solving abilities, and excellent communication skills for remote collaboration.

Benefits

• Highly competitive salary and comprehensive bonus program.
• Full remote work setup with provided equipment and home office stipend.
• Premium health, dental, and vision insurance coverage.
• Generous paid time off, including holidays and personal days.
• Opportunity to significantly impact the development of new medicines and advance your career from anywhere.