Remote Clinical Data Manager

Placements24

Durban

Hybrid

ZAR 600,000 - 900,000

Full time

6 days ago
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Benefits offered by this job

Private medical insurance
Retirement plan
Life assurance
Home office stipend
Professional growth opportunities

Job summary

Placements24's client, a global pharmaceutical leader, seeks a Remote Clinical Data Manager to oversee data collection, validation and database lock from a home office. You will collaborate with clinical operations, biostatistics and programming teams while ensuring data quality and regulatory compliance.

This fully remote role offers significant autonomy, exposure to multiple therapeutic areas, and opportunities to contribute to life-changing clinical research without geographical constraints.

Qualifications

  • Bachelor's degree in a scientific or healthcare-related field.
  • 5–8 years of progressive clinical data management experience.
  • Extensive experience with EDC systems (Medidata Rave, Oracle Clinical, Veeva).
  • Strong knowledge of ICH-GCP, FDA, and CDISC standards.
  • Proficiency in data validation, database design and query management.

Responsibilities

  • Oversee design, development and maintenance of clinical databases (EDC).
  • Develop and manage data management plans per study protocol.
  • Perform data validation checks and query resolutions.
  • Manage data lifecycle from setup to database lock.
  • Ensure ICH-GCP and regulatory compliance.
  • Mentor junior data management staff.
  • Manage vendor relationships for external DM services.

Skills

Clinical data management
Regulatory compliance
Data quality assurance
Analytical thinking
Remote collaboration

Education

Bachelor's degree in science/healthcare

Tools

Medidata Rave
Oracle Clinical
Veeva
SAS

Job description

About the Role

Our client, a global pharmaceutical leader focused on innovative drug development, is seeking a dedicated Remote Clinical Data Manager to join their expanding operations. This role is crucial for ensuring the accuracy, integrity, and timeliness of clinical trial data across multiple therapeutic areas. As a fully remote position, you will manage data collection, validation, and database lock activities from the comfort of your home office. You will work closely with clinical operations, biostatistics, and programming teams to maintain high data quality standards, adhering strictly to regulatory guidelines. This position is ideal for a meticulous and experienced professional who thrives in a flexible, results-oriented environment. The role offers significant autonomy and the opportunity to contribute to life-changing clinical research without geographical constraints.

Key Responsibilities
  • Oversee the design, development, and maintenance of clinical databases (e.g., EDC systems).
  • Develop and manage data management plans (DMPs) in accordance with study protocols and regulatory requirements.
  • Perform data validation checks, query generation, and resolution to ensure data accuracy and completeness.
  • Manage all aspects of the clinical data lifecycle, from database setup to database lock.
  • Ensure compliance with ICH-GCP guidelines and other relevant regulatory standards (e.g., FDA, EMA).
  • Liaise with clinical research associates (CRAs), investigators, and site staff on data-related issues.
  • Participate in the review of clinical study protocols, case report forms (CRFs), and other study documents.
  • Contribute to the development and implementation of data management standards and procedures.
  • Train and mentor junior data management personnel as needed.
  • Manage vendor relationships for external data management services.
Requirements
  • Bachelor's degree in a scientific or healthcare-related field (e.g., Biology, Nursing, Pharmacy, Computer Science).
  • Minimum of 5-8 years of progressive experience in clinical data management within the pharmaceutical or biotechnology industry.
  • Extensive experience with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, Veeva).
  • Strong understanding of clinical trial processes, regulatory requirements (ICH-GCP, FDA), and data standards (CDISC).
  • Proficiency in database design, data validation, and query management.
  • Excellent analytical, organizational, and problem‑solving skills.
  • Ability to manage multiple projects simultaneously and meet tight deadlines in a remote setting.
  • Strong written and verbal communication skills, with the ability to effectively communicate with diverse stakeholders.
  • Detail-oriented with a commitment to data accuracy and integrity.
  • Experience with data programming languages (e.g., SAS) for data review is a plus.
Benefits

This fully remote position offers a highly competitive salary and comprehensive benefits package, including private medical insurance, a robust retirement savings plan, and life assurance. We provide a home office stipend to ensure you have a productive and comfortable working environment. Opportunities for professional growth include access to industry conferences, training programs, and certifications. This role provides excellent flexibility, allowing you to manage your work schedule effectively. Our client fosters a culture of trust, collaboration, and innovation, recognizing the contributions of its remote workforce. You will be part of a mission-driven organization dedicated to advancing medical breakthroughs. Join a team that values your expertise and dedication, offering a fulfilling career path in clinical research management from anywhere.

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