Clinical Data Manager

Company: Integrated Resources, Inc ( IRI )
Location: Cambridge
Posted on: May 12, 2022

Job Description:

OBJECTIVES: --- The successful candidate will be responsible for working closely with LIMS vendors, and internal informatics specialists, in the installation, validation and implementation of biobanking and sample tracking LIMS systems. --- Responsible for initial and ongoing QA of all LIMS data imports, ICF attributes, child specimens and derivatives, as well as clinical data. --- Work with internal and external partners to develop processes and workflows for data flows, data mapping, data security and data QC. --- Work with data standards, data management, biostatistics and other key stakeholders to maintain and update existing biomarker data standards for clinical trial studies. --- Work with clinical teams to provide controlled terminology and mapping instructions for clinical biomarker data. --- Work with Translational Lead Scientists and Bioassay Scientists to develop data transfer specification documents that ensure complete and accurate delivery of clinical biomarker data. --- Interface with clinical project teams to mitigate issues with clinical biomarker data standards. --- Interface with vendors to mitigate issues with clinical biomarker data transfers, security and reporting. --- Work with internal and external stakeholders in refining clinical and biobanking ontologies to be used within LIMS systems. ACCOUNTABILITIES: --- Candidate should have prior experience with either clinical sample tracking or biobanking LIMS systems and have a solid technical understanding of integration features particularly around data flow. --- Technical knowledge to maintain and transfer electronic files through sFTP, APIs etc. --- Provides guidance and oversees data flow from internal and external data platforms. --- Experience in regulatory and quality standards around data requirements. --- An understanding of biomarker assay platforms (NGS, IHC, Flow Cytometry, etc.), and the types of data generated from such platforms, is highly desirable. --- Familiarity and experience with handling clinical data sets, clinical data standards (e.g. CDISC, SDTM) and related industry standards. --- Self-motivated --- Highly organized, highly detail-oriented, able to excel in a matrix team environment, with superior written and verbal communication skills. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: --- MS with 3+ years' experience, or BS with 5+ years' experience. Pharmaceutical / Biotech industry experience required. --- Strong working knowledge of clinical operations and how data flow occurs as part of an industry-sponsored clinical trial. --- Expert communication skills; ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments with and without authority. --- Broad and strong network in the industry, biotech, CRO communities, and health authorities. --- Have a strong understanding of the clinical trial sample and data lifecycle. LICENSES/CERTIFICATIONS: --- No specific license or certification required. PHYSICAL DEMANDS: --- Routine demands of an office based environment. TRAVEL REQUIREMENTS: --- Some domestic and international travel to company sites, biomarker vendors, conferences, and regulatory agencies may be required.

Keywords: Integrated Resources, Inc ( IRI ), Cambridge , Clinical Data Manager, Executive , Cambridge, Massachusetts