Senior Clinical Data Manager

Placements24; Randburg; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health insurance

Retirement plan with employer matching

Hybrid work model

Job summary

Placements24 is seeking an experienced Senior Clinical Data Manager for a prominent CRO in Randburg. You will oversee database design, development, and data management for complex multicenter trials, ensuring accuracy, integrity, and regulatory compliance from setup to database lock.

You will lead DM activities, develop DMPs/CRFs, and collaborate with biostatistics and programming to support regulatory submissions and research outputs. Hybrid work arrangements are available.

Qualifications

• Minimum 7 years of progressive clinical data management experience.
• Experience with EDC systems (Medidata Rave, Oracle Clinical, Inform).
• Strong knowledge of CDISC SDTM/ CDASH data standards.

Responsibilities

• Lead data management activities for multicenter trials from design to database lock.
• Develop and review DMPs, CRFs, and CRF completion guidelines.
• Ensure data quality, validation, and regulatory compliance (ICH-GCP).
• Mentor junior data management staff and collaborate with cross-functional teams.

Skills

Data management

Leadership

Analytical thinking

Communication

Problem solving

Prioritization

Education

Bachelor's degree in life sciences/related field

Advanced degree preferred

Tools

Medidata Rave

Oracle Clinical

Inform

SQL

Job description

About the Role

Our client, a prominent Contract Research Organization (CRO), is seeking a highly experienced Senior Clinical Data Manager to join their team, based in or near Randburg . This pivotal role involves overseeing the design, development, and management of clinical databases for complex multi-center clinical trials. The Senior Clinical Data Manager will be responsible for ensuring the accuracy, completeness, and integrity of clinical trial data, from database setup through to database lock. You will lead data management activities, working closely with clinical operations, biostatistics, and programming teams to deliver high-quality data crucial for regulatory submissions and research findings. This position offers a challenging and rewarding career opportunity within a fast-paced environment, contributing to the advancement of pharmaceutical research. You will play a key role in ensuring data standards and operational excellence. We are looking for a strategic thinker with exceptional data management skills and a commitment to quality in clinical research.

Key Responsibilities

• Lead and manage all aspects of clinical data management for assigned clinical trials, from database design to database lock.
• Develop and review Data Management Plans (DMPs), Case Report Forms (CRFs), and CRF Completion Guidelines.
• Oversee the design, build, testing, and validation of clinical databases using EDC systems.
• Develop and implement data validation procedures, including edit checks and data review processes.
• Manage data cleaning activities, query generation, and resolution in collaboration with clinical sites and other study team members.
• Ensure compliance with ICH-GCP guidelines, regulatory requirements, and internal SOPs.
• Provide guidance and mentorship to junior data management staff.
• Collaborate with biostatisticians and programmers to ensure data consistency and facilitate statistical analysis.
• Participate in cross-functional team meetings and contribute to study strategy.
• Contribute to the continuous improvement of data management processes and standards.

Requirements

• Bachelor's degree in a life science, computer science, statistics, or a related field; advanced degree preferred.
• A minimum of 7 years of progressive experience in clinical data management within a pharmaceutical or CRO setting.
• Proven experience with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, Inform).
• Strong understanding of clinical trial processes, ICH-GCP, and regulatory data requirements.
• Experience in developing DMPs, CRFs, and data validation plans.
• Excellent knowledge of data standards (e.g., CDISC SDTM, CDASH).
• Proficiency in SQL or other database query languages is a plus.
• Strong analytical and problem-solving skills.
• Excellent communication, interpersonal, and leadership abilities.
• Ability to manage multiple projects and prioritize tasks effectively in a hybrid work environment.

Benefits

• An attractive annual salary of ZAR.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with employer matching.
• Professional development opportunities and training programs.
• Hybrid work model offering flexibility between office and remote work.
• Exposure to a diverse range of therapeutic areas and global clinical trials.
• Collaborative and supportive team environment in Randburg .
• Opportunities for career growth and advancement within a leading CRO.