Senior Clinical Data Manager

Placements24; Polokwane; A distancia; ZAR 900.000 - 1.200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote health insurance

Dental insurance

Vision insurance

Paid time off

Flexible hours

Professional development budget

Bonuses

Descripción de la vacante

Placements24 is seeking an experienced Senior Clinical Data Manager to join a fully remote clinical operations team. You will lead data management from database design through database lock, partnering with cross-functional teams to ensure data integrity for global trials.

Requirements include at least 7 years in clinical data management, expertise with EDC systems such as Medidata Rave or Oracle InForm, and strong CDISC SDTM knowledge. A Bachelor's degree is required, with a Master’s preferred.

Formación

• Bachelor's degree in a scientific, health, or IT-related field; a Master’s degree is preferred.
• Minimum 7 years of clinical data management experience in pharma or CRO.
• Proven experience with EDC systems and CDISC SDTM data standards.
• Strong understanding of regulatory requirements and GCP applicable to data management.
• Excellent analytical, problem-solving, and organizational skills.

Responsabilidades

• Oversee all aspects of clinical data management from protocol through database lock.
• Lead database design, data validation plans, and data management standards.
• Ensure compliance with GCP, regulatory requirements, and SOPs for data collection.
• Manage data cleaning, query generation, resolution, and trend analysis.
• Provide leadership and guidance to junior staff and drive process improvements.
• Collaborate with clinical operations, biostatistics, and medical writing teams.

Conocimientos

CDISC SDTM

Data management

EDC systems

Regulatory knowledge

Data cleaning

Leadership

Communication

Remote work

Educación

Bachelor's degree in science/health/IT

Master's degree preferred

Herramientas

Medidata Rave

Oracle InForm

Descripción del empleo

About the Role

Our client is seeking an experienced Senior Clinical Data Manager to join their expanding, fully remote clinical operations team. This role is essential for ensuring the accuracy, completeness, and integrity of clinical trial data, which is fundamental to regulatory submissions and scientific research. You will lead data management activities from database design through database lock, working closely with clinical teams, biostatisticians, and programming groups. This is an exciting opportunity for a seasoned professional to take on significant responsibilities in a remote setting, contributing to the successful delivery of global clinical trials and advancing pharmaceutical innovation.

Key Responsibilities

• Oversee all aspects of clinical data management for assigned studies, from protocol development through database lock.
• Lead the design and development of clinical databases, data validation plans, and data management standards.
• Ensure compliance with GCP, regulatory requirements, and internal SOPs for data collection and management.
• Manage data cleaning activities, including query generation and resolution, and trend analysis.
• Provide leadership and guidance to junior data management staff and contribute to process improvements.
• Collaborate effectively with cross-functional teams, including clinical operations, biostatistics, and medical writing.

Requirements

• Bachelor's degree in a scientific, health, or IT-related field; Master's degree preferred.
• Minimum of 7 years of experience in clinical data management within the pharmaceutical or CRO industry.
• Proven experience with EDC systems (e.g., Medidata Rave, Oracle InForm) and data standards (e.g., CDISC SDTM).
• Strong understanding of clinical trial processes and regulatory requirements.
• Excellent analytical, problem-solving, and organizational skills.
• Effective communication and interpersonal skills, with the ability to work independently in a remote environment.

Benefits

• Highly competitive salary with performance-based bonuses.
• Comprehensive remote health, dental, and vision insurance.
• Generous paid time off and flexible working hours.
• Budget for professional development and continuing education.
• Opportunity to work on diverse and impactful clinical trial projects globally.