Clinical Data Manager (19-00470) – MA – Newton

 Title of Position: Clinical Data Manager
A minimum of 8 years' experience working as a Clinical Data Manager in the life
science/pharmaceutical/medical device industry, or an equivalent combination of
training and experience in clinical data and or a related field, with particular skills
and knowledge working on clinical trials following FDA/ICH guidelines.
This position will lead clinical data activities for multiple phases of trials and will
report to the Director of Clinical Affairs.
Essential Responsibilities and Duties:
¿ Works collaboratively with Clinical Affairs and R&D and is responsible for oversight
and execution of data management activities for assigned clinical trials including
data timelines and key deliverables
¿ Manages data management CRO and oversees database development, UAT, data
import specifications, Case Report Form completion guidelines, data entry
guidelines, data management plan development according to ICH/GCP/CFR
guidelines and other current regulatory requirements and best practices
¿ Leads eCRF design
¿ Manages and supports vendors contracted to assist in the conduct of the clinical
trial, including, but not limited to CROs, Labs, and IRT
¿ Supports R&D with development of analysis plan
¿ Prepares reports, statistical comparisons, data charts and other presentation
materials as needed
¿ Responsible for executing data cleaning activities: including generating and
managing clinical trial data queries, management of coding for specified clinical trial
data, e.g. adverse events and concomitant medications, reconciling serious adverse
events (MedDra)
¿ Supports coordination of randomization procedures and blinding
¿ Conducts central monitoring using source data generated by the Lumicell imaging
system as needed
¿ Contribute to preparation of reports and analyses reflecting study progress,
enrollment trends and appropriate recommendations and conclusions
¿ Experience with Electronic Data Capture (EDC) system(s) is required
¿ Familiarity with data standards is required
¿ Oncology or imaging experience preferred

Source: Job Diva – Job Listing

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