11 дней назад
Data Team Lead (Clinical Data Management)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Data Team Lead (Clinical Data Management): Leading clinical data management activities for pharmaceutical, biotech, and medical device trials with an accent on EDC systems, data validation, query resolution, and regulatory compliance. Focus on developing eCRFs and data management plans, performing UAT, overseeing database lock and QC audits, and coordinating study data teams.
Location: Home-based in South Africa, with locations listed in Bloemfontein, Johannesburg, Pretoria, Cape Town, and Durban.
Company
is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data management and regulatory submission services.
What you will do
- Lead clinical data management studies or small data management project teams for one client.
- Develop eCRFs, CRF Completion Guidelines, edit check specifications, and data management plans.
- Oversee CRF tracking, data entry, external data integration, validation, review, query processing, and resolution.
- Manage adverse event and medication coding, SAE reconciliation, database lock, and database QC audits.
- Perform UAT for EDC and integrated systems, including test plans and scripts.
- Create study tracking and metric reports and support EDC training for sites and users.
Requirements
- College degree in a scientific, medical, clinical, or related discipline, or equivalent experience.
- At least 5 years of experience as a Data Team Lead or in a similar role.
- Expert knowledge of scientific principles and concepts, with experience in clinical trials and pharmaceutical development preferred.
- Knowledge of EDC systems, clinical data terminology, CRO operations, and the drug development process.
- Familiarity with 21 CFR Part 11, FDA, GCP, ISO 9001, and ISO 27001 requirements.
- Strong communication, organization, problem-solving, and collaboration skills, plus proficiency with MS Office.
Culture & Benefits
- Home-based work in South Africa.
- Collaborative and inclusive work environment.
- Opportunity to contribute to clinical research supporting pharmaceutical, biotech, and medical device development.
- Great Place to Work certified organization with a focus on employee retention and supportive teamwork.
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