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Clinical Data Manager

Job Description:
o Takes ownership for all Clinical Data Management owned
deliverables within assigned compound, projects and studies and provides
leadership to respective CDM staff, interfacing functions and teams in
order to support and achieve defined business goals
o Serves as the key subject matter expert on topics related to data
management activities. Contributions include, but are not limited:
vendor selection and management, mentoring junior staff, training team
members, leading or contributing to expert working groups (e.g., SOPs,
OM''s, PGDs, etc.), presenting best practices at internal and external
industry meetings meetings/congresses, and participating in due
diligence assessments.
o Governs use of key data management elements across studies in
assigned compound/project: assumes ownership of development and
maintenance Medical Standards relevant to the area of responsibility
(GMS/TAS/CPS/Codelists) provides data structure standards review
application of the Important Medical Event (IME) List, medical coding
conventions, and standard coding rules.
o Ensures adequate application of Data Management Best Practices
across studies within assigned project: review Study Team documents for
project consistency ensure the adequate documentation of all data
management activities according to SOPs.
o Provides oversight for outsourcing activities by providing input
on budgetary items (e.g. RFP, vendor costing, synergies, change orders,
etc.), vendor selection and management, risk and communication
management, and application of best data management practices.
o Advises on resource planning/allocation based on forecasted
activities per the Clinical Development Plan and actual study/project
metrics.
o Supports the development and implementation of Project and Study
Data Management strategic initiatives and activities.
o Contributes to projects and initiatives aimed at improving and
optimizing the delivery of Global Clinical Data Management, GDS&A and
GCD services.
o Performs duties in compliance with SOPs, GCP and ICH guidelines
in accordance with regulatory, legal and ethical standards.
o Ensures complete, accurate and timely documentation for all
projects/studies according to established SOPs, Operational Instructions
(OIs) and Process Guidance Documents (PGDs


REQUIREMENTS:

Data Management, oncology experience preferred The incumbent possesses a high skill and knowledge level in all aspects
of clinical data management. The incumbent can
lead a study or project data management team independently. The
incumbent may lead complex projects to improve best practices and is
respected as a reliable partner in Global Clinical Teams and Study
Teams
o Bachelor's degree (or equivalent) in Natural Sciences,
Informatics or Medical Documentation
o At least 9 years of study and/or project level experience as a
Data Manager in supportive and leading roles.
o At least 4 years of experience should demonstrate responsibility
as the DM lead on studies/project(s).
o (As a guide) at least 2 years acting as a Project Data Manager
o Deep understanding of the drug development process
o Highly effective self-management and organizational skills
o Basic SAS Programming knowledge, or other database experience,
preferred
o Strong experience of using data management methodologies and
technologies (e.g. data warehousing, electronic data capture)
o Strong understanding of regulations and guidelines (e.g. ICH,
GCP, European Clinical Trials Directive, Privacy rules HIPPA )
o The incumbent is required to conduct him/herself in an
appropriate business manner adhering to a high ethical standard


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