MMS Holdings

About MMS Holdings

About MMS Holdings MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn. About the position: Data Team Lead We are recruiting for an experienced Data Team Lead to take on a position in our South Africa team. We are looking for a motivated self-starter with existing Data Team Lead experience who is looking for a fresh challenge. This position is a home-based role out of any location in South Africa or office-based role out of our Bloemfontein location. Roles & Responsibilities Responsible for entire data management process from study set-up to study close-out; primary contact on all data management study-specific issues; has high level knowledge of drug development as it pertains to data management Strong understanding of GCP/ICH guidelines and FDA regulations, as applicable to data management Actively participates in protocol review with clients, providing suggestions regarding ability to capture protocol information in database successfully Creates training exercises; serves as mentor and trains new clinical data managers Provides oversight and resolves all issues in data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g. lab data) with clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits Oversees and develops data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan Prepares any study tracking and metric reports for use by the study team Oversees execution of user acceptance testing (UAT) of study-specific systems and applications Interacts with cross-functional team members to ensure completion of all timelines and studies Participates in data management and/or organizational initiatives Initiates SOP updates and provides specifications for DM systems/tools and process improvements May act as a high-level APP resource for cross-functional team, as requested May act as a resource for QC activities in collaboration with QC Coordinator Understands and follows processes related to project management as appropriate for data management projects (e.g. updating PWA, close-out procedures, etc.) Displays a confident, positive attitude towards clients and projects Willing to learn new skills and expand knowledge of drug development Leads data management projects with little management oversight Ability to work independently and resolve issues Complete compliance to applicable IMS policies and procedures and ensures compliance of DM team Job Requirements (Minimum Education / Experience / Training / Skills) Master's or Bachelor's degree in scientific or healthcare field preferred with industry experience 5+ years' experience in data management field with a minimum of 1 years' experience leading projects Intermediate SAS or other relevant programming skills, with extensive experience in relational databases Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems Extensive knowledge of Clinical Operations SOPs and WPs Excellent verbal and written communication skills, as well as, interpersonal and organizational skills Familiarity with ISO 9001:2015 and ISO 27001:2013 requirements If we do not make contact within 14 days of your application being submitted, please consider your application unsuccessful. N1BT1UvJ7s

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Company Info

Legal Form: LTD

Company Type: Private

Company Size: 501 - 1000

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Hiring Locations: 40

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