Data Team Lead

1 week ago

Johannesburg South, South Africa Arborvitae.in Full time

Job Title: Data Team Lead

Department: Clinical Data Management, Biometrics Team

Location: South Africa

Experience Required: 5-8 Years

**Job Type**: Full-Time

Job Summary:
We are seeking an experienced and highly motivated Data Team Lead to join our

experience in Clinical Data Management (CDM) with strong leadership skills, hands
- on experience in managing clinical data, and a deep understanding of regulatory

requirements. You will lead a team responsible for the collection, management, and

analysis of clinical trial data, ensuring accuracy, consistency, and compliance with

clinical protocols and industry regulations.

Key Responsibilities:

- Leadership and Team Management:

- Lead and mentor a team of clinical data managers and data

associates.
- Delegate tasks, monitor progress, and ensure project timelines are

met.
- Provide training and support to junior staff in clinical data management

practices.
- Clinical Data Management:

- Oversee the design, development, and implementation of clinical

databases for trials.
- Ensure the integrity and accuracy of clinical trial data through effective

data cleaning and validation processes.
- Coordinate data collection, entry, and management activities across

different trials.
- Review clinical data to ensure it meets protocol requirements and

regulatory standards.
- Project Management:

- Work closely with cross-functional teams including biostatisticians,

clinical operations, and regulatory teams.
- Develop and manage project timelines, ensuring data management

deliverables are achieved within scope.
- Participate in protocol reviews, case report form (CRF) development,

and database specifications.
- Regulatory Compliance:

- Ensure data management processes are compliant with ICH-GCP, 21

CFR Part 11, FDA, and other applicable regulations.
- Prepare and present data management reports for audits, inspections,

and regulatory submissions.
- Stay up-to-date with industry standards and implement best practices

within the team.
- Stakeholder Management:

- Liaise with internal and external stakeholders, including sponsors, to

ensure data management deliverables align with project goals.
- Provide regular updates on data quality and project status to key

stakeholders.

Qualifications:

- Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Pharmacy, or

related field.
- 5-8 years of experience in Clinical Data Management, with at least 2-3 years

in a leadership or supervisory role.
- Hands-on experience with EDC (Electronic Data Capture) systems, data

cleaning, and data validation processes.
- Proficiency in using CDM tools such as Medidata Rave, Oracle Clinical, or

other EDC platforms.
- Strong knowledge of ICH-GCP, 21 CFR Part 11, and other clinical data

management regulations.
- Exceptional organizational and multitasking abilities.
- Excellent communication and interpersonal skills to lead a team and interact

with cross-functional teams.
- Certification in clinical data management (e.g., CCDM) is a plus.

**Job Types**: Full-time, Permanent

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