Data Team Lead (Home Based - South Africa) at MMS · Bloemfont…

ExperiencedOn-siteFull-timeBloemfontein, Free State, South Africa

Skills

ms officeich21crf part 11iso 9001iso 7001ecrf developmentcrf completion guidelinesedit check specsdmpstudy trackingmetric reportsdata validationquery processingadverse event codingmedication codingsae reconciliationdatabase lockdatabase qc auditsuser acceptance testing (uat)edc systemscommunicationproblem solvingorganizational skillsleadershipclinical trial experiencepharmaceutical development experienceiso 27001fda regulationsgcp requirementscro experience

Job Description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit http://www.mmsholdings.com or follow MMS on LinkedIn.

Data Team Lead

Roles and Responsibilities

Proficient with MS Office applications.
Understand ICH, 21CRF Part 11, ISO 9001 and ISO 7001.
Ability to develop eCRFs, CRF Completion Guidelines, Edit check specs, and DMP.
Create study tracking and metric reports for use by 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.
Perform user acceptance testing (UAT) of EDC and integrated systems including development of test plan and scripts.
Assist with preparation for training sites/users training on EDC applications, and UAT.
End user knowledge for study conduct activities including queries management, standard reporting and extracting data in multiple EDC systems.
Lead studies or small DM project teams for one client.

Job Requirements

College graduate in scientific, medical, clinical discipline or related field, or related experience.
Minimum of 5 years’ experience as a Data Team Lead or similar field required.
Expert knowledge of scientific principles and concepts.
Reputation as emerging leader in field with sustained performance and accomplishment.
Proficiency with MS Office applications.
Hands-on experience with clinical trial and pharmaceutical development preferred.
Good communication skills and willingness to work with others to clearly understand needs and solve problems.
Excellent problem-solving skills.
Good organizational and communication skills.
Familiarity with current ISO 9001 and ISO 27001 standards preferred.
Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

Should you not receive a response on your application within 14 days, please consider your application unsuccessful.