[Remote] Lead - Clinical Data Manager / Data Analytics

Note: The job is a remote job and is open to candidates in USA. Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. The Lead Clinical Data Manager is responsible for overseeing clinical data management activities, ensuring high quality and reliable clinical data for complex studies, and driving data management strategy to enhance efficiency and innovation.ResponsibilitiesWorks closely with the Sr. Manager, Clinical Data Management / Analytics in building an efficient and compliant data management function that meets industry standards and supports regulatory inspectionsDriving global data management and data analytics strategy related to technologies and processes to increase efficiency, innovation and data quality for complex studiesLeads all data management aspects from startup to database lock, including Data Management Plans (DMP), Edit Checks, and Data Review PlansOversees the development and validation of Electronic Data Capture (EDC) systems, ensuring CDISC standards are metOverseeing the collection, validation, processing and analyzing of more complex clinical trial dataDeveloping and implementing data management and data analytic procedures for clinical trialsSupporting and facilitating the review of medical coding for validity and completenessEnsuring compliance with applicable regulations, protocols and standard operating proceduresMaintain the highest data quality standards throughout the data lifecycle, from data collection to database lockStay updated on industry best practices, technological advancements and regulatory requirements related to clinical data management and data analyticsDevelop and maintain data management documentation, including clinical study protocols, statistical analysis plans, case report forms and data management plansDesign case report forms (CRFs) and electronic data capture (EDC) systems for data collectionPerform cleaning activities, including discrepancy management and query resolutionConduct data validation checks and implement quality control measures to ensure accuracy and completenessDevelop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approvalCollaborate with study team members to resolve data-related issues and discrepanciesGenerate and review data listings, summaries and reports for clinical study reportsServe as a primary or backup resource for issues about data managementEnsure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulationsContribute to the development and validation of data management software toolsOversee the data analytics for Convatec clinical trials to ensure data analyses are performed on time and within budgetCollaborate with Clinical Study Managers in leading the data analytics for the various clinical trials to ensure robust analyses are conducted per protocol and to identify patterns in the data (trends) and improve processesSkillsBachelor's degree in a scientific or healthcare-related field or a computer science degree or equivalent professional certification4-6 years of experience in clinical data management or a similar role in the medical device or clinical research industryStrong understanding of clinical trial processes, data management principles and regulatory guidelinesProficiency in electronic data capture (EDC) systems (i.e. Veeva) and clinical data management softwareFamiliarity with relevant regulations and guidelines, like GCP and CDISC standardsKnowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle ClinicalExcellent attention to detail with problem-solving and analytical skillsStrong organisational and time management abilitiesCompany OverviewConvaTec specializes in the development, manufacture, distribution of single-use devices to hospitals and healthcare sectors. It was founded in 1978, and is headquartered in Reading, Reading, GBR, with a workforce of 5001-10000 employees. Its website is https://www.convatecgroup.com.Company H1B SponsorshipConvatec has a track record of offering H1B sponsorships, with 1 in 2023, 1 in 2021, 6 in 2020. Please note that this does not guarantee sponsorship for this specific role.