Clinvia LLC
Principal Clinical Data Manager -Consulting
Clinvia LLC, Menlo Park, California, United States, 94029
Responsibilities
Main point of client contact and study team for all DM related matters.
Execute all DM start-up activities, including the development and maintenance of eCRFs.
Define and create data listings, summary table validation, data specifications, and process data transfers for statistical review.
Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and final database lock.
Set and create the database and support the development of the study eCRF, validating them and assessing the correct functionality of the eCRF developed, in compliance with applicable quality validation standards.
Coordinate and execute the coding activities (using known dictionaries, e.g., MeDRA, WHO), drug safety reconciliation, and data review.
Reconcile Safety and Efficacy Data.
Qualifications
7+ years relevant data management experience in the CRO/pharmaceutical industry required.
EDC Designing and UAT experience is required.
Proven ability to use statistical software - SAS.
Demonstrates knowledge of GCPs and protocol.
Strong time management and prioritization skills to meet deadlines.
Strong project management and communication skills (verbal/written).
Experience in pharmacology and drugs life cycle.
Knowledge of ICH-GCP.
Strong analytic and quantitative background.
Excellent Microsoft Office skills.
Job Type:
Contract
Pay:
$80.00 - $95.00 per hour
Benefits:
401(k)
Dental insurance
Health insurance
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Ability to Relocate:
Menlo Park, CA: Relocate before starting work (Required)
Work Location:
In person
#J-18808-Ljbffr
Main point of client contact and study team for all DM related matters.
Execute all DM start-up activities, including the development and maintenance of eCRFs.
Define and create data listings, summary table validation, data specifications, and process data transfers for statistical review.
Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and final database lock.
Set and create the database and support the development of the study eCRF, validating them and assessing the correct functionality of the eCRF developed, in compliance with applicable quality validation standards.
Coordinate and execute the coding activities (using known dictionaries, e.g., MeDRA, WHO), drug safety reconciliation, and data review.
Reconcile Safety and Efficacy Data.
Qualifications
7+ years relevant data management experience in the CRO/pharmaceutical industry required.
EDC Designing and UAT experience is required.
Proven ability to use statistical software - SAS.
Demonstrates knowledge of GCPs and protocol.
Strong time management and prioritization skills to meet deadlines.
Strong project management and communication skills (verbal/written).
Experience in pharmacology and drugs life cycle.
Knowledge of ICH-GCP.
Strong analytic and quantitative background.
Excellent Microsoft Office skills.
Job Type:
Contract
Pay:
$80.00 - $95.00 per hour
Benefits:
401(k)
Dental insurance
Health insurance
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Ability to Relocate:
Menlo Park, CA: Relocate before starting work (Required)
Work Location:
In person
#J-18808-Ljbffr