Clinical Data Manager
Company: Katalyst Healthcares & Life Sciences
Location: Redwood City
Posted on: February 17, 2025
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Job Description:
Responsibilities:Support the planning, setup, and acquisition of
external clinical data at the study level, assisting in managing
study start-up, conduct, and closeout activities.Assist in creating
external data transfer agreements, ensuring alignment and
specifications to support data integration, analysis, and
reporting.Provide support in setting up infrastructure for external
data to flow into Clinical data pipelines.Assist in validation of
all Data generated in clinical trials into Clinical Data
pipelines.Develop and maintain working relationships with key
stakeholders like Clinical Data Management, Clinical Data
Engineering, Standards, and other Study Execution Team
members.Assist in preparing function for submission readiness and
may support Clinical Trial Tools & Technologies (CT3) group in
formal inspections or audits.Act as a representative for Takeda in
interactions with key external partners as part of the CT3 Data
Acquisition team.Support timely submission and ongoing maintenance
of study-related Data Acquisition documentation in TMF.Follow
procedural documents and assist in reviewing and updating documents
to ensure they reflect industry standards and regulatory
requirements and include optimal processes.Escalate issues to CT3
leadership as appropriateDevelop working knowledge and
understanding of FDA and ICH regulations and industry standards and
quality control principles.Gain exposure to all phases of drug
development.Assist in handling Clinical data acquisition and
management May support study-level negotiation and agreement for
data transfer or integration Collaborate with all levels of
employees with moderate supervision required.Familiarity with FTP
tools like GlobalScape, Clinical platforms like Veeva CDMS,
Elluminate, and Veeva TMF will be beneficial.
Keywords: Katalyst Healthcares & Life Sciences, Redwood City , Clinical Data Manager, Executive , Redwood City, California
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