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Job #02579

About our client Our client is a biopharmaceutical company dedicated to discovering, developing and commercializing orally active drugs that address significant unmet medical needs. Primarily focused on the treatment of cancer and inflammatory disease, their proprietary drug development pipeline includes several small molecule drug candidates designed to regulate targets in therapeutically important biologic pathways. This company aims to be the most efficient inventor of therapeutic products in the pharmaceutical industry. Position Location Clinical Data Manager Colorado Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage and coordinate all activities related to design and release of clinical study database from study concept to database lock (creation of data management plans, definition and validation of edit checks, etc.) in order to meet project requirements and timelines 2) Support program managers and Study Team, acting as key liaison with data management CROs 3) Perform various tasks like SOP review, QA and regulatory compliance 4) Schedule audits and supervise CRO data management activities inter-phasing the internal and external environments 5) Collaborate and coordinate with study team members to assist in designing, reviewing and implementing high quality clinical protocols and data collection systems with emphasis in exploratory development (Phase 1 and 2) 6) Develop systems for organizing data to analyze, identify and report data and trends 7) Design online case report forms for an EDC data management system 8) Develop, train and implement in-house DM SOPs, guidelines and standards to ensure consistent and constant interpretation of data 9) Create CRF completion guidelines 10) Track status of CRF retrieval and queries for all studies 11) Support the generation of clinical study reports and annual reports such as IB, IND annual updates, etc. Requirements 1) BS or MS degree 2) Minimum 5 years of data management experience in a biotechnology/pharmaceutical setting 3) Experience in clinical data management, clinical study database design and implementation and generation of clinical study reports/listings 4) Experience in SAS programming and working with an Electronic Data Capture (EDC) system and reviewing/approving their output (preferably Medidata RAVE) 5) Experience in Case Report Form (CRF) designing (paper and electronic) 6) Experience in working with CROs 7) Experience in implementing Clinical Data Interchange Standards Consortium (CDISC) standards preferred 8) Background in oncology/inflammation preferred 9) Experience in utilizing programs to code medical terms and medications 10) Solid understanding of the clinical drug development process 11) Strong working knowledge of MS Word, Excel and Access 12) Ability to work independently 13) Excellent problem solving, planning and organizational skills 14) Detail-oriented with attention to follow up 15) Effective interpersonal and communication (oral and written) skills