Data Team Lead (South Africa)
MMS Holdings Inc.
Free State | Gauteng | Western Cape | KZN | North West, ZA
3d ago

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, 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 the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. 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 Clinical Data Management experience who is looking for a fresh challenge. This position is a home- or office-based role out of our Bloemfontein location.

Roles & Responsibilities 

  • Clinical Research Data Management Experience Required
  • Ability to support the 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
  • Participates in protocol review with clients when required displaying strong client interaction skills
  • Creates training exercises; serves as mentor and trains junior data management roles when required
  • Provides technical oversight of 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
  • Assist with the development of 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
  • Execution (support and assistance where required) 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
  • Assists with 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
  • Understands how to comply with Document Control Procedure
  • Understands how to comply with Record Control Procedure
  • Ability to work independently and resolve issues pro-actively
  • Complete compliance to applicable IMS policies and procedures and ensures compliance of DM team

Job Requirements (Minimum Education / Experience / Training / Skills)

  • Bachelor’s degree in scientific or healthcare field preferred with industry experience
  • 4+ years’ experience in clinical data management field 
  • Basic SAS or other relevant programming skills, with extensive experience in relational databases will be beneficial
  • Intermediate knowledge of paper CRF study systems, EDC, and hybrid CDM systems
  • Intermediate 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
  • Bloemfontein based candidates will receive preference

If we do not make contact within 14 days of your application being submitted, please consider your application unsuccessful. 

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