Senior Clinical Data Manager - Pharmaceutical

Placements24; Kimberley; Hybrid; CAD 75,000 - 117,000; Full time

Benefits offered by this job

Fully remote work arrangement

Health insurance

Professional development

Retirement savings plan

Job summary

Placements24 is seeking a Senior Clinical Data Manager to join a globally distributed team. This fully remote role oversees the end-to-end data lifecycle for clinical trials, ensuring data accuracy, completeness, and regulatory compliance.

You will lead the design of data management plans, EDC setup and validation, data validation, query management, and database lock activities, while mentoring junior staff and collaborating with biostatisticians and investigators to deliver high-quality data

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• At least 5 years of clinical data management experience.
• Proven experience with EDC systems (Medidata Rave, Oracle Clinical, Veeva EDC).
• Strong knowledge of CDISC SDTM and regulatory requirements.
• Excellent analytical, communication, and organizational skills.
• Ability to work independently in a remote setting.

Responsibilities

• Lead the design and development of data management plans (DMPs).
• Oversee the setup and validation of EDC systems for clinical trials.
• Develop data validation specifications and implement data cleaning activities.
• Manage the query generation and resolution process to ensure data accuracy and completeness.
• Perform quality control checks on clinical trial databases.
• Oversee the database lock process for clinical trial databases.
• Ensure compliance with data management SOPs, ICH-GCP guidelines, and regulatory requirements.
• Train and mentor junior data management personnel.
• Liaise with clinical study teams, biostatisticians, programmers, and investigators on data management issues.
• Contribute to the continuous improvement of data management processes and systems.

Skills

Clinical data management

EDC systems

CDISC SDTM

Regulatory compliance

Data quality assurance

Analytical thinking

Remote work

Project coordination

Communication skills

Education

Bachelor's degree in Life Sciences or related field

Tools

Medidata Rave

Oracle Clinical

Veeva EDC

Job description

About the Role

Our client, a cutting-edge pharmaceutical research company, is actively seeking an experienced Senior Clinical Data Manager to join their globally distributed team. This fully remote position offers the chance to manage critical clinical trial data from anywhere. You will be responsible for overseeing the collection, cleaning, and database lock of clinical trial data, ensuring its accuracy, completeness, and integrity. This role requires a deep understanding of data management principles, EDC systems, and regulatory compliance within the pharmaceutical industry. As a Senior Data Manager, you will play a crucial role in supporting clinical research activities and ensuring that data meets the highest standards for analysis and regulatory submission. Your contributions will directly impact the success of clinical trials and the advancement of new therapies.

Key Responsibilities

• Lead the design and development of clinical data management plans (DMPs).
• Oversee the setup and validation of Electronic Data Capture (EDC) systems for clinical trials.
• Develop data validation specifications and implement data cleaning activities.
• Manage the query generation and resolution process to ensure data accuracy and completeness.
• Perform quality control checks on clinical trial databases.
• Oversee the database lock process for clinical trial databases.
• Ensure compliance with data management SOPs, ICH-GCP guidelines, and regulatory requirements.
• Train and mentor junior data management personnel.
• Liaise with clinical study teams, biostatisticians, programmers, and investigators on data management issues.
• Contribute to the continuous improvement of data management processes and systems.

Requirements

• Bachelor's degree in a relevant scientific or technical field (e.g., Computer Science, Statistics, Life Sciences).
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Proven experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva EDC).
• Strong understanding of clinical trial processes, data standards (e.g., CDISC SDTM), and regulatory requirements.
• Excellent analytical, problem-solving, and organizational skills.
• Proficiency in database management and data validation techniques.
• Strong communication and interpersonal skills.
• Ability to work independently and manage multiple projects in a remote setting.
• Must be able to work remotely from Kimberley, Northern Cape, ZA .

Benefits

• Annual salary of R .
• Comprehensive health, dental, and vision insurance.
• Paid time off and holidays.
• Retirement savings plan.
• Opportunities for professional development and certification.
• Fully remote work arrangement with a supportive team.