Clinical Data Manager

Placements24; East London; Hybrid; ZAR 700,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Generous paid time off

Job summary

Placements24 is seeking a meticulous Clinical Data Manager to join a global clinical operations team in a fully remote capacity. You will oversee the data management lifecycle from design to database lock, ensuring data integrity for regulatory submissions and drug approvals.

The role requires 5+ years in clinical data management, knowledge of ICH-GCP, and experience with Medidata Rave or Oracle Clinical. Strong analytical skills and remote-work capability are essential.

Qualifications

• Bachelor's degree in a relevant scientific or technical field.
• Minimum of 5 years of clinical data management experience.
• Strong knowledge of ICH-GCP and regulatory data management requirements.
• Experience with clinical data management systems (EDC).

Responsibilities

• Oversee design, setup, and maintenance of clinical databases.
• Develop and implement data management plans (DMPs).
• Lead data cleaning, query resolution, and discrepancy reconciliation.
• Perform quality checks for accuracy, completeness, and consistency.
• Collaborate with Clinical Operations, Biostatistics, and Programming teams to ensure timely database lock.
• Manage external vendors involved in data management activities.

Skills

Analytical thinking

Detail oriented

Remote work capability

Education

Bachelor's degree in a scientific or technical field

Tools

Medidata Rave

Oracle Clinical

Job description

About the Role

Our client is looking for a meticulous and experienced Clinical Data Manager to join their global clinical operations team in a fully remote capacity. This role is essential for ensuring the integrity, accuracy, and consistency of clinical trial data that underpins critical drug development decisions. You will be responsible for overseeing the entire data management lifecycle, from database design and setup to data validation, cleaning, and database lock. This is an excellent opportunity for a data-focused professional to contribute to life-changing pharmaceutical research from anywhere, working within a collaborative environment that values precision, efficiency, and timely data delivery to support regulatory submissions and drug approvals.

Key Responsibilities

• Oversee the design, setup, and maintenance of clinical databases, ensuring compliance with protocol and regulatory requirements.
• Develop and implement data management plans (DMPs), including data validation specifications and data review guidelines.
• Lead data cleaning activities, including query generation, resolution, and reconciliation of discrepancies.
• Perform quality control checks on clinical data to ensure accuracy, completeness, and consistency.
• Collaborate with Clinical Operations, Biostatistics, and Programming teams to ensure timely database lock.
• Manage external vendors involved in data management activities, as required.

Requirements

• Bachelor's degree in a relevant scientific or technical field (e.g., Statistics, Computer Science, Life Sciences).
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotech industry.
• Strong understanding of clinical trial processes, ICH-GCP guidelines, and regulatory requirements for data management.
• Proficiency with clinical data management systems (e.g., EDC systems like Medidata Rave, Oracle Clinical).
• Excellent analytical and problem-solving skills with a keen eye for detail.
• Ability to work independently, manage multiple projects, and meet strict deadlines in a remote setting.

Benefits

• Competitive annual salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance coverage.
• Retirement savings plan with employer contributions.
• Generous paid time off and professional development opportunities.
• Flexible remote working arrangements and support for home office setup.