About this role
MMS, an award-winning, data-focused clinical research organization (CRO), is hiring a Data Team Lead for a home-based role in South Africa (Bloemfontein, Johannesburg, Pretoria, Cape Town, Durban, or elsewhere across Free State, Gauteng, Western Cape, KZN, North West or Eastern Cape), full time. MMS supports the pharmaceutical, biotech and medical device industries with a scientific approach to complex trial data and regulatory submission challenges, and operates across four continents.
Roles and responsibilities: proficiency with MS Office applications; understanding of ICH, 21 CFR Part 11, ISO 9001 and ISO 27001; ability to develop eCRFs, CRF Completion Guidelines, edit check specs and DMPs; creating study tracking and metric reports for the study team; oversight of CRF tracking and data entry, integration of external electronic data, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits; performing user acceptance testing (UAT) of EDC and integrated systems, including test plan and script development; assisting with site/user training preparation on EDC applications and UAT; end-user knowledge for study conduct activities including query management, standard reporting and data extraction across multiple EDC systems; and leading studies or small DM project teams for one client.
Requirements: college degree in a scientific, medical or clinical discipline (or related experience); minimum 5 years' experience as a Data Team Lead or similar role; expert knowledge of scientific principles and concepts; a reputation as an emerging leader with sustained performance; proficiency with MS Office; hands-on clinical trial/pharmaceutical development experience preferred; strong communication, organizational and problem-solving skills; familiarity with ISO 9001/ISO 27001 preferred; familiarity with 21 CFR Part 11, FDA and GCP requirements; and a basic understanding of CROs, clinical data/terminology and the drug development process.