Clinical Data Manager

Placements24; LegKraal Gate; Hybrid; ZAR 600.000 - 900.000; Vollzeit

Benefits dieser Stelle

Health insurance

Paid time off

Retirement savings options

Hybrid work model

Zusammenfassung

Placements24 is seeking a meticulous Clinical Data Manager to join a CRO-focused team supporting pharma and biotech trials. The role combines hybrid on-site collaboration with remote work and training sessions to ensure high-quality data throughout the lifecycle of clinical studies.

You will design and validate databases, manage data cleaning, and ensure adherence to ICH-GCP and privacy regulations. A strong background in EDC systems and cross-functional collaboration is essential.

Qualifikationen

• Bachelor's degree in Life Sciences, Computer Science, Statistics or Health Informatics.
• Minimum 3 years of Clinical Data Manager experience in CRO/pharma.
• Proficiency with EDC systems (Medidata Rave, Oracle InForm, Veeva EDC).
• Strong understanding of clinical trial processes, ICH-GCP, data management best practices.
• Experience in database design, data validation, and query management.
• Excellent organizational and time-management abilities.
• Strong written and verbal communication skills.

Aufgaben

• Oversee design, build, and testing of clinical databases using EDC systems.
• Develop Data Management Plans (DMPs) outlining data handling procedures.
• Define data validation specs and write validation checks.
• Manage data cleaning including generating and resolving data queries.
• Ensure data accuracy and consistency with study protocols and DMPs.
• Perform UAT for databases and related systems.
• Collaborate with operations, biostatistics, and programming teams.
• Contribute to SOPs for data management.
• Participate in study team meetings with data updates.
• Ensure compliance with FDA/EMA data privacy regulations.

Kenntnisse

Clinical data management

Analytical thinking

Regulatory compliance

Communication skills

Ausbildung

Bachelor's degree in Life Sciences or related

Experience in CRO/pharma

Tools

Medidata Rave

Oracle InForm

Veeva EDC

Jobbeschreibung

About the Role

Our client, a prominent Contract Research Organization (CRO), is seeking a meticulous and organized Clinical Data Manager to join their team serving clients in the pharmaceutical and biotech industries. This hybrid role allows for flexible remote work combined with necessary on-site collaboration and training sessions. You will be responsible for the end-to-end management of clinical trial data, ensuring data quality, integrity, and consistency from database setup through database lock. This includes database design, data validation, query management, and adherence to regulatory standards such as ICH-GCP. The ideal candidate will have a strong understanding of clinical trial processes, excellent data management skills, and a commitment to accuracy. This position is vital for supporting the successful execution of clinical trials and contributing to the development of new medicines. You will work with a variety of therapeutic areas and clinical study designs.

Key Responsibilities

• Oversee the design, build, and testing of clinical databases using EDC systems.
• Develop Data Management Plans (DMPs) outlining data handling procedures.
• Define data validation specifications and write validation checks.
• Manage data cleaning activities, including generating and resolving data queries.
• Ensure data accuracy, completeness, and consistency in accordance with study protocols and DMPs.
• Perform User Acceptance Testing (UAT) for clinical databases and related systems.
• Collaborate with clinical operations, biostatistics, and programming teams to ensure efficient data flow.
• Contribute to the development and maintenance of standard operating procedures (SOPs) for data management.
• Participate in study team meetings and provide updates on data management activities.
• Ensure compliance with regulatory requirements (e.g., FDA, EMA) and data privacy regulations.

Requirements

• Bachelor's degree in a relevant field such as Life Sciences, Computer Science, Statistics, or Health Informatics.
• Minimum of 3 years of experience as a Clinical Data Manager in a CRO or pharmaceutical company.
• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle InForm, Veeva EDC).
• Solid understanding of clinical trial processes, ICH-GCP guidelines, and data management best practices.
• Experience in database design, data validation, and query management.
• Strong analytical and problem-solving skills.
• Excellent organizational and time management abilities.
• Good written and verbal communication skills.
• Ability to work effectively both independently and as part of a hybrid team.
• Attention to detail and commitment to data quality.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including health insurance, paid time off, and retirement savings options. The hybrid work model provides flexibility and work-life balance. Employees have access to advanced technology and training resources to support their professional growth. We foster a collaborative and supportive work environment within our Mahikeng operational hub and remote settings. Opportunities for career advancement within a growing CRO are significant. Join our dedicated team and play a crucial role in advancing clinical research and drug development.