Remote Clinical Data Manager

Placements24; Rustenburg; Hybrid; ZAR 500.000 - 900.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Health, dental, and vision insurance

Generous paid time off

Professional development opportunities

Remote work support

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

EDC systems

GCP knowledge

Data analysis

Remote work

CDISC SDTM/ADaM

Ausbildung

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

Tools

Medidata Rave

Oracle Clinial

Inform

Jobbeschreibung

About the Role

Our client, a rapidly growing Contract Research Organization (CRO) focused on global clinical trials, is seeking a dedicated and experienced Remote Clinical Data Manager to join their dispersed team. This is a fully remote position, allowing you to contribute to groundbreaking pharmaceutical research from the comfort of your home office. The primary focus will be on ensuring the quality, integrity, and accuracy of clinical trial data collected across various studies. You will be responsible for establishing data management plans, overseeing data collection, cleaning, and database lock procedures. This role is essential for supporting our clients in bringing life‑changing therapies to market faster and more efficiently. We are looking for a detail‑oriented professional with a strong understanding of clinical trial processes and data standards.

Key Responsibilities

• Develop and implement Clinical Data Management Plans (CDMPs) for assigned clinical trials.


• Oversee the design and validation of Electronic Data Capture (EDC) systems and databases.


• Manage data cleaning activities, including query generation, resolution, and trending.


• Ensure compliance with Good Clinical Practice (GCP), regulatory requirements (e.g., FDA, ICH), and company SOPs.


• Lead cross‑functional teams in data review meetings to ensure data accuracy and completeness.


• Perform User Acceptance Testing (UAT) for EDC systems and data management tools.


• Participate in database lock activities and ensure timely closure of clinical databases.


• Contribute to the development and maintenance of data management standards and best practices.


• Train and mentor junior data management staff on EDC systems and data management processes.


• Act as a primary point of contact for data management‑related issues for study teams and clients.

Requirements

• Bachelor's degree in a life science, computer science, or related field.


• Minimum of 5 years of experience in clinical data management within the pharmaceutical or CRO industry.


• Proven experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Inform) and data cleaning processes.


• Solid understanding of clinical trial lifecycle, GCP, and regulatory guidelines (ICH, FDA).


• Experience in developing CDMPs, CRFs, and database specifications.


• Proficiency in data analysis and reporting tools.


• Excellent organizational and time management skills, with strong attention to detail.


• Ability to work independently and manage multiple projects simultaneously in a remote setting.


• Strong verbal and written communication skills, with the ability to effectively collaborate with global teams.


• Familiarity with CDISC standards (SDTM, ADaM) is a significant advantage.

Benefits

• Our client provides a highly competitive salary, comprehensive health, dental, and vision insurance, and a generous paid time off policy.


• Opportunities for professional development, including access to online training platforms and industry conferences, are available.


• You will be part of a forward‑thinking organization that values innovation, collaboration, and employee well‑being.


• As a remote employee, you will receive support to set up an effective home office and maintain a healthy work‑life balance.