Job Title

Job purposeReporting to the Director of Biometrics, the Senior Clinical Data Manager (CDM) will primarily oversee the data management activities at Blue Earth Diagnostics. They will provide subject matter expertise in regard to database design, data transfers, vendor interactions and timelines. This includes authoring and/or reviewing documents in relation to database design, interim analyses and database locks. The CDM also serves as the point of contact for Data Management (DM) related activities with vendors, vendor selection/bid defense meetings and developing companywide DM standards library of Case Report Forms (CRF) and edit check specifications.Main Responsibilities, Activities, Duties and Tasks Fulfil the role of lead data manager on all clinical trial project projects as part of the biometrics team.Contribute to CRF Design and Edit Checks Development for Electronic Data Capture (EDC) platforms (e.g., Medidata RAVE)Reviewing of DM documentation including Data Management Plans, Data Transfer Specifications, Edit Check Specifications and support User Acceptance Testing (UAT)Actively participate in DM activities including cross-functional meetings and vendor management callsInvolved in developing Standards library for CRFs and Edit checks in relation to CDISC standards and Study Data Tabulation Model (SDTM) mapping for future trialsProvide support in data review and data reconciliation, and monitor the work performed by Clinical Research Organization (CRO) on data cleaning and data reconciliation until the end of the trialSupport the data review/cleaning in clinical studies e.g. creating internal checks using SAS or other programming softwareReview of study protocols, Statistical Analysis Plans, Tables/Listings/Figures, and CSRs.Creation/review of standard operating procedures related to data management.Provide internal data management training to other functions within Blue Earth Diagnostics as required.Input into and management of clinical study data management budgets for upcoming and ongoing clinical trialsOther duties as determined by business needs.EducationBSc (Hons) Life Sciences or a related fieldProfessional Experience, Knowledge & Technical SkillsExtensive experience as a data manager at a pharmaceutical/biotechnology company or contract research organizationExperience working closely with outsourced study vendorsGood understanding of SAS programming concepts or other computing softwareGood understanding of CDASH and CDISC StandardsGood understanding of the drug development processProficient understanding of DM processes and documentationKnowledge of Good Clinical Practice (GCP) regulations/requirementsOncology and diagnostic imaging experienceSoft Skills – Company Values & BehavioursAbility to work in a high paced team environment, meet deadlines, & prioritize work on multiple projectsAbility to accurately estimate effort required for project related data management activities.Strong coaching, facilitation, and organizational skills; team player. Experience and skills with cross-functional and highly matrixed organizations.Excellent oral & written communication skills. Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.Strong coaching, facilitation, and organizational skills