Senior Data Team Lead, home-based in South Africa
7 days ago
RESPONSIBILITIES Serve as primary point of contact for customer on data management deliverables Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global programs of global studies Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise Lead direct negotiations with customer, e.g., timelines, financial, process, resources Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects Serve as the escalation point for unresolved data issues Ensure appropriate resources are assigned to meet project deliverables Create and/or review and sign-off on all data management plan (DMP) documents Manage service performance and provide leadership to identify root causes of issues and implement remedial actions Serve as Subject Matter Expert (SME) Provide leadership and expertise in a specific CDM task or technology Independently manage SOW/budget Independently bring process improvements and solutions to the CDM team/CDM department Lead a focus team or global or local best practice team Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients) Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation) Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology Knowledge of operating procedures and work instructions and the ability to apply them in practice Knowledge of Good Clinical Practices and relevant regulatory guidelines Excellent communication, interpersonal, customer service, and teamwork skills Excellent organizational and problem-solving skills Excellent project management skills Ability to work independently Comprehensive understanding of clinical drug development process Ability to establish and maintain effective working relationships with co-workers, managers and customers MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at #J-18808-Ljbffr
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Bloemfontein, South Africa IQVIA Argentina Full timeRESPONSIBILITIES Serve as primary point of contact for customer on data management deliverables Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global programs of global studies Provide project management expertise working with customer data managers, key decision makers,...
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Bloemfontein, South Africa IQVIA Full timeRESPONSIBILITIES Serve as primary point of contact for customer on data management deliverables Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global programs of global studies Provide project management expertise working with customer data managers, key decision makers,...
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Bloemfontein, South Africa ZAF IQVIA RDS Clindepharm Full timeIQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to...
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Senior Data Team Lead, Fsp
4 days ago
Bloemfontein, South Africa IQVIA Full time**RESPONSIBILITIES** - Serve as primary point of contact for customer on data management deliverables - Manage multiple large studies or program of studies (possibly global) - Provide leadership and senior support to DTLs on multiple large global programs of global studies - Provide project management expertise working with customer data managers, key...
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Senior Regulatory Affairs Associate
2 weeks ago
Bloemfontein, South Africa Parexel Full timeWe are looking for a **Senior **Regulatory Affairs Associate with working knowledge of Clinical Trial Applications (CTA) **to join our team in South Africa! This role can be office based (Bloemfontein) or home based anywhere in South Africa. As a Senior Regulatory Affairs Associate, you will ensure the timely performance of work within a project scope to...
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SHE Officer
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Bloemfontein, South Africa AVBOB South Africa Full timeJoin to apply for the SHE Officer role at AVBOB South Africa Join to apply for the SHE Officer role at AVBOB South Africa Responsibilities Implement and monitor company SHE policies and procedures. Conduct risk assessments (HIRA) and enforce preventative measures. Carry out regular site inspections, audits, and safety walks. Lead 5S activities, and drive...
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Bloemfontein, South Africa Metronomia Clinical Research GmbH Full timeSince 1990, METRONOMIA has stood for quality, competence, continuity and unconditional customer orientation in terms of data management, statistical services and medical writing in clinical research. As a growth-oriented medium-sized company with over 145 employees, we operate internationally. Our customers appreciate the competence and commitment of our...
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Private Banking Advisor Private Affluent
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Bloemfontein, South Africa Syneos Health Full timeA leading biopharmaceutical solutions organization seeks a Project Data Manager in Bloemfontein, South Africa. The role involves overseeing data management activities, ensuring compliance with project milestones, and fostering collaboration among teams. Candidates should have a degree in biological sciences and strong project management skills. Experience in...
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Project Data Manager
4 weeks ago
Bloemfontein, South Africa Syneos Health Full timeProject Data Manager (Romania, Poland, Hungary, Slovakia, South Africa Only) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings...
