Clinical Data Manager
Company: Integrated Resources, Inc ( IRI )
Posted on: May 12, 2022
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
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