Associate EDS Portfolio Lead
Posted on: October 12, 2021
EDS Portfolio Lead
responsibility and accountability for quality, delivery and
timeliness of the project/study.
serve as point of contact to the client and manage sponsor
relationship across the portfolio.
the Vendor Data Plan (VDP), including the Data Quality Review
reconciliation section, or sponsor equivalent, for the external
vendor data transfer(s), obtain final approvals and file document
to the Trial Master File (TMF) as applicable.
for communication and managing relationship with external vendor
and sponsor counterparts for study expectations including
milestones, deliverable timelines, communication expectations,
participate in review of external vendor Statement of Work (SOW)
for study scope, and ensure all protocol specified parameters are
present as applicable.
electronic external vendor data transfers contain all protocol
specified parameters, is in correct format, and data populates to
the specified fields and subjects correctly as designated in the
Vendor Data Plan (VDP) or sponsor equivalent.
and document external data edit checks and reports in the edit
check template or sponsor equivalent, obtain approvals and perform
QC/UAT to verify the checks and reports are functioning
external data discrepancies generated by edit checks and reports
and perform subsequent query management to resolve data
appropriate documentation of data issues in both study and vendor
logs and follow outcome to resolution.
assist with review of draft protocols from an external data
perspective and assist with review of eCRF design per protocol
with other study team functions to gather feedback and address any
issues that could impact data review or analysis.
work with clinical staff to obtain and QC local laboratory ranges
and verify the normal ranges are properly attached to the subject
results in the local lab data.
in study team and department meetings as applicable.
plan and support multiple increasingly complex and high quality
external data management projects simultaneously and provide
updates to line management or other relevant stakeholders as
Covance by Labcorp and sponsor (if applicable) trainings in a
timely manner and perform job functions in accordance with set
guidance/mentoring and assist with training of junior or new team
members as appropriate.
assist with evolving external data management practices or
optimizing current processes for efficiency and
other duties as required by the department.
or bachelor’s degree in Medical/Life Science/Computer Science or
equivalent combination of education and experience to successfully
perform the key responsibilities of the job.
years prior experience in the pharmaceutical, biotechnology,
medical device/diagnostics, or clinical trial industries to include
data management or an equivalent combination of education and
experience to successfully perform the key responsibilities of the
Management experience strongly preferred. Basic understanding of
medical terminology a plus.
organizational, planning, and critical-thinking skills.
inclusive, and engaging communication skills (written and verbal)
to support effective interactions with sponsors and internal
negotiation skills to facilitate, guide, influence, and produce a
unified approach within a global, cross-functional
to handle multiple tasks in a timely and professional manner under
to use standard Microsoft suite of software products.
to maintain confidentiality of data and information during
interaction with staff at all levels.
of ICH-GCP principles.
Keywords: Labcorp, Minneapolis , Associate EDS Portfolio Lead, Other , Minneapolis, Minnesota
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