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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 and Responsibilities:Confidently displays excellent internal and external customer serviceHas proficiency and knowledge of multiple EDC systems; applies this knowledge to advise customers regarding the best-fit EDC solutionInteracts directly and independently with DM suppliers including EDC and/ or IWR; expert communicator, where necessary negotiating with supplier to meet business needsInteracts directly and independently with client to coordinate all facets of projects; expert communicator; builds and maintains strong client contacts and relationshipsResponsible 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 managementActively participates viding suggestions regarding ability to capture protocol information in database successfullyStrong understanding of GCP/ ICH guidelines and FDA regulations, as applicable to data managementCreates training exercises; serves as mentor and trains new clinical data managersProvides oversight and resolves all issues egration 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 auditsOversees 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 PlanPreparation of any study tracking and metric reports for use by the study teamOversees execution of user acceptance testing (UAT) of study-specific systems and applicationsInteracts with cross-functional team members to ensure completion of all timelines and studiesParticipates in data management and/or organizational initiativesInitiates SOP updates and provide specifications for DM systems/ tools and process enhancementsMay act as resource for QC activities in collaboration with QC CoordinatorUnderstands and follows processes related to project management as appropriate for data management projects (e.g., updating PSS, close-out procedures, etc.)Confident, positive attitude displayed towards clients and projectsWillingness to learn new skills and expand knowledge of drug developmentLeads data management projects with little management oversightAbility to work independently and resolve issuesAbility to clearly articulate the DM services offered at company, including pros and cons of various DM approaches (specific to a client or operating model). To include potential attendance at (web or remote) capabilities and bid defense meetingsRequirements:Bachelor’s or Master’s Degree in scientific or health care field preferred with industry or relevant experience5+ years’ experience in data management field with a minimum of 1 year of experience leading projectsExtensive knowledge of paper CRF study systems, EDC, and hybrid CDM systemsExtensive knowledge of Clinical Operations SOPs and Working PracticesExcellent verbal and written communication skills, as well as, interpersonal and organizational skillsPlease consider your application unsuccessful if we do not reach out to you within 14 days of your submission.
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