Overview

Position Title: Senior Manager-Clinical Data Solutions
Location: Remote (Work from Home)
Experience in Oncology needed; Cell Therapy highly preferred

OBJECTIVES:
Responsible for timely and high quality data management deliverables
supporting the Client portfolio.

Establish asset and study level strategies and services, including
excellence in the application of standards.

Conduct oversight using, predictive data monitoring practices from
database activation through database release and submission.

Contributes to the management of vendor partnerships to maximize
effectiveness and maintain budgets.

Provides and enables solutions for complex problem solving that align
with the Clients values.

Serves as a clinical data management expert and provides guidance on
CDISC standards.

ACCOUNTABILITIES:

Responsible for vendor oversight activities across global
development programs. Represents data management function on the
Clinical Sub-team ensuring aligned expectations between the CRO and
Client for all data related deliverables, especially in support of key
decision points and regulatory submissions.
Contributes influential leadership in collaboration with other
Client Stakeholders to ensure established milestones and deliverables
are met with the highest degree of quality.
Provides input to functional governance with Client strategic
suppliers. Partners with appropriate stakeholders to resolves issues
escalated from the vendor and/or cross-functional teams.
Ensures achievement of major data management deliverables and
milestones in coordination with other functions including the
Therapeutic Area Units, Clinical Operations, Statistical Programming
and Statistics.
Ensure archival and inspection readiness of all Data Management
Trial Master File (TMF) documents
Oversees the planning and management of external Data Management
budgets and timelines to ensure accuracy, understand trends in
variances and support continuous improvement in forecasting.
Represents function in external professional initiatives and
organizations such as SCDM, CDISC, DIA, etc. to identify industry best
practice and increase the visibility of clients.
Participates and represents function in formal inspections and
audits as requested.
Other duties as assigned

– provided by DiceTracking

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