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Responsibilities
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.Roles & ResponsibilitiesServes as Database Administrator for Argus Safety, including database configuration, issue resolution, maintenance, governance and daily supportPerforms installations, upgrades, configuration of reporting rules, and E2B reporting via gateway technologies (including set-up and configuration of Axway Gateway Interchange)Provides support for all systems associated with PV and drug safetyPerforms updates to Argus configuration and processes as per changing Eudravigilance regulationsProvides support and execution of activities related to Eudravigilance testing for various clientsPerforms case migration/database transfers, file importing and supports other case processing activitiesProvides leadership in executing Argus upgrades and related activitiesProvides administrator support for other safety databases (such as ARISg)Performs periodic coding dictionary (MedDRA & WHO drug) updates for ArgusProvides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agenciesWrites procedural documents including Standard Operating Procedures (SOP), Work Practice Documents, and Data Entry Manuals for Argus SafetyGenerates case processing metrics, reviews and makes suggestions and supports process improvement implementationMaintains technical expertise of regulatory requirements and ensures alignment with company working practicesAssists with business development and capabilities efforts as neededInteracts directly and independently with client to coordinate all facets of projects; competent communicator, supports client capabilities as PV/drug safety systems SMEStrong understanding and experience working with Argus configuration and study set upStrong understanding of global case processing and SAE reportingStrong understanding of global clinical trial development and dataRequirementsCollege graduate Information Technology discipline or related field, or related experienceMinimum of 5 years’ experience in Information Technology or similar field requiredExpert knowledge of scientific principles and conceptsReputation as emerging leader in field with sustained performance and accomplishmentProficiency with MS Office applicationsHands-on experience with clinical trial and pharmaceutical development preferredGood communication skills and willingness to work with others to clearly understand needs and solve problemsExcellent problem-solving skillsGood organizational and communication skillsFamiliarity with current ISO 9001 and ISO 27001 standards preferredFamiliarity with 21 CFR Part 11, FDA, and GCP requirementsBasic understanding of CROs and scientific & clinical data/terminology, & the drug development processPlease consider your application unsuccessful if we do not reach out to you within 14 days of your submission.
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