Lead Clinical Data Manager - Pharmaceutical Trials

Placements24; Cape Town; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Health benefits

Performance incentives

Generous annual leave

Retirement plan

Work from home

Job summary

Placements24 is seeking an experienced Lead Clinical Data Manager to spearhead data management for critical clinical trials. Based remotely but overseen for the Cape Town, Western Cape region, this role ensures data integrity from study startup through database lock while leading a team of data managers.

You will design and validate databases using EDC systems (Medidata Rave, Oracle InForm, Veeva Vault EDC), develop DM Plans, and ensure compliance with GCP and regulatory requirements.

Qualifications

• Bachelor's or higher in a scientific/technical field; Master's preferred.
• Minimum 7 years in clinical data management; 3+ years in lead/supervisory role.
• Experience with EDC systems: Medidata Rave, Oracle InForm, Veeva Vault EDC.
• Strong knowledge of GCP, ICH guidelines and regulatory requirements.
• Excellent leadership and communication skills; ability to manage multiple projects remotely.

Responsibilities

• Lead and mentor a team of clinical data managers.
• Design, develop, and validate databases using EDC systems.
• Develop and maintain Data Management Plans (DMPs).
• Define CRF design and edit check specifications.
• Manage data cleaning, queries, and trend analysis.
• Ensure adherence to GCP, regulatory requirements and SOPs.
• Coordinate with CROs and tech vendors for data flow and integration.
• Provide status updates in trial team meetings; drive process improvements.
• Ensure timely database lock for assigned studies.

Skills

Leadership

Data management

Communication

Problem solving

Education

Bachelor's degree in a relevant field

Master's degree preferred

Tools

Medidata Rave

Oracle InForm

Veeva Vault EDC

Job description

About the Role

Our client, a globally recognized pharmaceutical leader, is actively seeking an experienced and dynamic Lead Clinical Data Manager to spearhead data management operations for their critical clinical trials. This pivotal role, based remotely but overseen for the Cape Town, Western Cape region, will ensure the integrity, accuracy, and completeness of clinical trial data from study startup through database lock. You will lead a team of data managers, establish and enforce data management standards, and collaborate closely with cross-functional teams, including clinical operations, biostatistics, and IT. This is an exceptional opportunity to contribute to the development of life-saving medications while enjoying the flexibility of a fully remote position. Your expertise will be vital in maintaining compliance and driving efficient data operations.

Key Responsibilities

• Lead and mentor a team of clinical data managers, providing guidance on study conduct and data management best practices.
• Oversee the design, development, and validation of clinical databases using EDC systems.
• Develop and maintain comprehensive Data Management Plans (DMPs) for assigned clinical studies.
• Define data collection standards, Case Report Form (CRF) design, and edit check specifications.
• Manage data cleaning activities, including query generation, resolution, and trend analysis.
• Ensure adherence to Good Clinical Practice (GCP), regulatory requirements (e.g., FDA, EMA), and company SOPs.
• Liaise with external vendors, including CROs and technology providers, to ensure seamless data flow and integration.
• Participate in clinical trial team meetings, providing updates on data management status and risks.
• Contribute to the continuous improvement of data management processes and systems.
• Ensure timely database lock for assigned studies.

Requirements

• Bachelor's degree in a relevant scientific or technical field (e.g., Computer Science, Statistics, Life Sciences). A Master's degree is a plus.
• A minimum of 7 years of progressive experience in clinical data management within the pharmaceutical or CRO industry.
• At least 3 years of experience in a lead or supervisory role managing data management teams.
• In-depth knowledge of Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault EDC).
• Strong understanding of clinical trial phases, study design, and regulatory requirements (GCP, ICH guidelines).
• Proficiency in database design, data validation strategies, and data quality control techniques.
• Excellent leadership, communication, and interpersonal skills.
• Proven ability to manage multiple projects simultaneously in a remote, fast-paced environment.
• Strong problem-solving skills and attention to detail.

Benefits

• This remote position offers a highly competitive salary, comprehensive health and wellness benefits, performance-based incentives, generous annual leave, and a retirement savings plan.
• We provide opportunities for professional development, including access to training and conferences.
• As part of our commitment to work-life balance, you will enjoy the flexibility of working from home, supporting our operations in the Cape Town, Western Cape region and beyond.