Remote Clinical Data Manager - Pharmaceutical Trials

Placements24; Soweto; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Remote work stipend

Health benefits

Professional development

Flexible schedule

Autonomy in remote environment

Job summary

Placements24 is seeking a Remote Clinical Data Manager to lead end-to-end data management for international clinical trials. You will oversee database design, UAT, CDMPs, and data validation to ensure high-quality data for regulatory submissions.

The role requires 4+ years in clinical data management, strong CDMS/EDC experience (Medidata Rave, Oracle InForm), and a solid grasp of CDISC SDTM with GCP/ICH guidelines. This is a fully remote position supporting global studies.

Qualifications

• Bachelor's degree in a scientific, technical, or healthcare-related field.
• Minimum of 4 years of experience in clinical data management within pharma/biotech.
• Proficiency with clinical data management systems (CDMS) and EDC platforms (e.g., Medidata Rave, Oracle InForm).
• Solid understanding of clinical trial processes, data standards (CDISC SDTM), and regulatory requirements.
• Experience developing data validation checks, managing data queries, and performing database lock.

Responsibilities

• Oversee design, development, and UAT of clinical databases and EDC systems.
• Develop CDMPs and data collection guidelines.
• Define data validation procedures and write validation specs.
• Manage data cleaning, including queries, resolution, and tracking.
• Ensure data management activities comply with GCP, ICH, and SOPs.
• Collaborate with CRAs, statisticians, and programmers to ensure data quality.

Skills

CDMS

EDC platforms

GCP

Data validation

Query management

Analytical skills

Education

Bachelor's degree in science/healthcare

Tools

Medidata Rave

Oracle InForm

CDISC SDTM

Job description

About the Role

Our client, a global pharmaceutical company committed to improving patient lives, is seeking a skilled Remote Clinical Data Manager to join their dynamic Clinical Operations team. This position is fully remote, allowing you to contribute from anywhere. You will be responsible for the end-to-end management of clinical trial data, ensuring its accuracy, completeness, and integrity from database setup to database lock. This role is vital for supporting the successful execution of clinical trials and ensuring the quality of data used for regulatory submissions and scientific analysis. The ideal candidate has a strong understanding of clinical data management processes, databases, and relevant regulations, coupled with excellent organizational and problem-solving skills. Join us in advancing groundbreaking medical treatments from the convenience of your home office.

Key Responsibilities

• Oversee the design, development, and UAT (User Acceptance Testing) of clinical databases and electronic data capture (EDC) systems.
• Develop clinical data management plans (CDMPs) and associated data collection guidelines.
• Define data validation procedures, write data validation specifications, and execute data validation checks.
• Manage data cleaning activities, including query generation, resolution, and tracking.
• Ensure data management activities comply with Good Clinical Practice (GCP), ICH guidelines, and company SOPs.
• Collaborate with clinical research associates (CRAs), study statisticians, and programmers to ensure data quality and consistency.
• Oversee external data integrations (e.g., central labs, imaging) into the clinical database.
• Prepare and manage the database lock process for clinical study databases.
• Contribute to process improvement initiatives within the clinical data management function.
• Maintain accurate and complete audit trails for all data management activities.

Requirements

• Bachelor's degree in a scientific, technical, or healthcare-related field.
• Minimum of 4 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Proficiency with clinical data management systems (CDMS) and EDC platforms (e.g., Medidata Rave, Oracle InForm).
• Solid understanding of clinical trial processes, data standards (e.g., CDISC SDTM), and regulatory requirements.
• Experience in developing data validation checks, managing data queries, and performing database lock.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Excellent organizational and time management skills, with the ability to manage multiple tasks effectively in a remote setting.
• Effective communication and interpersonal skills, with the ability to collaborate across functions.
• Knowledge of medical coding dictionaries (MedDRA, WHODrug) is a plus.

Benefits

• Competitive salary and remote work stipend.
• Comprehensive health, dental, and vision insurance plans.
• Generous paid time off and holidays.
• Opportunities for professional development and continuous learning.
• The flexibility and autonomy of a fully remote work environment.
• Direct impact on clinical trial success and the advancement of new therapies.
• A collaborative and supportive remote team culture.