Remote Clinical Data Manager - EDC & CDMP Lead

Placements24; Rustenburg; Hybride; ZAR 500 000 - 900 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Health, dental, and vision insurance

Generous paid time off

Professional development opportunities

Remote work support

Résumé du poste

Placements24 is seeking a Remote Clinical Data Manager to join a globally dispersed team. You will ensure data quality and integrity across clinical trials, establish data management plans, and oversee data collection, cleaning, and database lock procedures from a home office.

The role requires 5+ years in clinical data management, strong EDC tool experience (Medidata Rave, Oracle Clinical, Inform), and solid knowledge of GCP and CDISC standards.

Qualifications

• 5+ years of experience in clinical data management within pharma or CRO environments.
• Strong understanding of clinical trial lifecycle, GCP, and regulatory guidelines (ICH, FDA).
• Experience developing CDMPs, CRFs, and database specifications.
• Proficiency with data cleaning, query resolution, and data management tools.
• Experience validating EDC systems and performing UAT.

Responsabilités

• Develop and implement CDMPs for assigned trials.
• Oversee design and validation of EDC systems and databases.
• Manage data cleaning activities, including query generation and resolution.
• Ensure compliance with GCP, regulatory requirements, and SOPs.
• Lead cross-functional data review meetings for accuracy and completeness.
• Perform UAT for EDC systems and data tools.
• Participate in database lock activities and timely closure of databases.
• Contribute to data management standards and best practices.
• Train and mentor junior data management staff on EDC systems.

Connaissances

EDC systems

GCP knowledge

Data analysis

Remote work

CDISC SDTM/ADaM

Formation

Bachelor's degree in life sciences / computer science / related field

Outils

Medidata Rave

Oracle Clinial

Inform

Description du poste

Placements24 is seeking a Remote Clinical Data Manager to join a globally dispersed team. You will ensure data quality and integrity across clinical trials, establish data management plans, and oversee data collection, cleaning, and database lock procedures from a home office.

The role requires 5+ years in clinical data management, strong EDC tool experience (Medidata Rave, Oracle Clinical, Inform), and solid knowledge of GCP and CDISC standards.