Senior Clinical Data Manager

Contenu de l'offre Senior Clinical Data Manager chez CLINSEARCH

ClinSearch is a software publisher and a full-service clinical research organization (CRO) with extensive experience in Clinical Operations, Data Management, including Clinical Safety Data Management, Biostatistics and Medical Writing.

Our clients include national and international biopharmaceutical and medical device companies.

The Senior Clinical Data Manager is responsible for all Data Management tasks from study start-up to database lock.

Responsibilities

Develop and maintain study-specific documentation, including but not limited, Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Database Audit and Lock ProceduresWork with DB programmers to design (e)CRFs and edit checks in EDC systemLead, coordinate, and perform User Acceptance Testing tasksEnsure proper completion of QC of EDC tools and modulesTroubleshoot technical issues as appropriateDesign “smart” listings and study-specific processes for effective data review, query issue and resolutionManage queries and trends to ensure data completeness and integrityPerform coding of adverse events, medical conditions and medicationsPerform SAE reconciliationLead and perform pre-lock and data lock tasksPrepare training materials and user guides for EDC data collection tools, deliver user trainingParticipate in client and team meetings as required, providing status updates and advising on best practices as appropriateDesign, generate, and review status metric reports, identifying and communication trends as neededEnsure archiving of study databases and related documentsOrganize and file study documentationProvide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changesLead client and team meetings as requiredDelegate tasks as appropriate, providing mentorship and following through completionPresent at sales and marketing meetings for prospective clientsDevelop SOPs and manuals

Education/Experience

Minimum BS in a scientific or health-related fieldMinimum 5 years of experience in Clinical Data Management SkillsExpert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management SystemsSAS and SQL database programming (queries and PL/SQL under Oracle)Knowledge and understanding of regulations and standards such as GCDMP, SDTM, STDMIG, SDTMIG-MD and CDASH Experience working with Oracle InForm, Medidata Rave and MedrioExperience using standardized medical terminology, including MedDRA and WHODrugExcellent organizational and time management skillsStrong collaboration and leadership skills.

Type d'emploi : Temps plein, CDI

Horaires :

Du Lundi au VendrediPériodes de Travail de 8 Heures

Télétravail:

Temporairement en raison du COVID-19