Senior Clinical Data Manager

Placements24; Mbombela (Nelspruit); On-site; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement savings plan

Professional development opportunities

Job summary

Placements24 seeks a Senior Clinical Data Manager to lead data management across clinical trials in Nelspruit, Mpumalanga. You will design and validate databases (EDC), develop CDMPs, manage queries, and drive data quality for regulatory submissions.

You will collaborate with clinical operations, biostatistics, and programming teams to ensure timely, high‑quality data delivery. A strong background in GCP and CDISC is required, with mentorship responsibilities in a dynamic environment.

Qualifications

• Bachelor’s degree in a scientific or technical field.
• Minimum 6 years of experience in clinical data management.
• Experience managing DM activities for Phase I–IV trials.
• Proficiency with EDC systems (Medidata Rave, Oracle Clinical, Veeva).
• Strong understanding of CDISC data standards and regulatory requirements.
• Excellent data validation and cleaning knowledge.
• Strong analytical, problem‑solving and organizational skills.
• Excellent written and verbal communication skills.
• Ability to lead multiple projects independently.
• Experience in Mpumalanga region or similar environments is a plus.

Responsibilities

• Oversee and manage all aspects of clinical data management for assigned clinical trials.
• Lead development and maintenance of CDMPs (clinical data management plans).
• Design, build, and validate clinical databases (EDC) with programming teams.
• Develop data validation specs and perform data review and cleaning.
• Manage query generation and resolution to ensure data accuracy.
• Oversee database lock processes for clinical trial databases.
• Ensure compliance with GCP, SOPs, and regulatory requirements.
• Collaborate with cross‑functional teams (clinical ops, biostatistics, medical writing, safety).
• Participate in vendor selection and management for data management services.
• Mentor and guide junior data management personnel.

Skills

CDISC

Data management

EDC systems

Medidata Rave

Oracle Clinical

Veeva EDC

GCP compliance

Project management

Mentoring

Regulatory knowledge

Education

Bachelor’s degree in a scientific or technical field

Fields: Computer Science / Statistics / Biology / Pharmacy

Tools

Medidata Rave

Oracle Clinical

Veeva EDC

Job description

About the Role

Our client, a leading pharmaceutical company dedicated to innovative drug development, is seeking an experienced Senior Clinical Data Manager for their site in Nelspruit, Mpumalanga . This role is pivotal in ensuring the integrity, accuracy, and quality of clinical trial data. You will lead data management activities throughout the clinical trial lifecycle, from database design and development to data validation, cleaning, and database lock. The successful candidate will work closely with clinical operations, biostatistics, and programming teams to ensure timely and high-quality data delivery for regulatory submissions. This position demands a meticulous approach, strong technical skills in clinical data management systems, and a thorough understanding of clinical trial processes and regulatory requirements. You will be instrumental in supporting the development of life-saving therapies by ensuring the reliability of the data that underpins critical decisions. Your expertise in data handling and quality control will be essential for maintaining the highest standards of clinical research. This role offers a challenging yet rewarding opportunity to contribute to cutting-edge pharmaceutical research within a dynamic team. The environment encourages collaboration and a commitment to excellence in data management practices.

Key Responsibilities

• Oversee and manage all aspects of clinical data management for assigned clinical trials.
• Lead the development and maintenance of clinical data management plans (CDMPs).
• Design, build, and validate clinical databases (e.g., EDC systems) in collaboration with programming teams.
• Develop data validation specifications and perform data review and cleaning activities.
• Manage query generation and resolution processes to ensure data accuracy and completeness.
• Oversee the process of database lock for clinical trial databases.
• Ensure compliance with Good Clinical Practice (GCP) guidelines, company SOPs, and regulatory requirements.
• Collaborate with cross-functional teams, including clinical operations, biostatistics, medical writing, and safety.
• Participate in the selection and management of third-party vendors for data management services.
• Mentor and provide guidance to junior data management personnel.

Requirements

• Bachelor's degree in a scientific or technical field (e.g., Computer Science, Statistics, Biology, Pharmacy).
• Minimum of 6 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Proven experience in managing data management activities for Phase I-IV clinical trials.
• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, Veeva EDC).
• Strong understanding of clinical trial processes, data standards (e.g., CDISC), and regulatory requirements.
• Excellent understanding of data validation principles and data cleaning techniques.
• Strong analytical, problem-solving, and organizational skills.
• Effective written and verbal communication skills.
• Ability to work independently and manage multiple projects simultaneously.
• Experience working in the Mpumalanga region or similar clinical research environments is an advantage.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including health, dental, and vision insurance, as well as retirement savings plans. This role provides opportunities for professional growth through advanced training in data management technologies and clinical research methodologies. You will be part of a collaborative and innovative team based in Nelspruit , contributing to the advancement of critical pharmaceutical research. Our client is committed to fostering a supportive work environment that values expertise and encourages professional development. The opportunity to work in Nelspruit offers a unique setting within the pharmaceutical industry in South Africa, contributing to vital healthcare advancements.