Sr Clinicial Data Manager

4 weeks ago

Noida, Uttar Pradesh, India MEDTEK AI Full time

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 or final database lock

Set and create the data base and support the development of the study eCRF and then validate them, assessing the correct functionality of the eCRF developed, in compliance with the applicable quality validation standards

Coordinate and execute the coding activities (by using the known dictionaries, e.g. MeDRA, WHO etc), drug safety reconciliation and data review

Qualifications

Min 5 years relevant data management experience in the CRO/pharmaceutical industry required

EDC experience required

Proven ability to use statistical software - SAS

Demonstrates knowledge of GCPs and protocol

Strong time management and prioritisation skills to meet deadlines

Strong project management & communication skills (verbal/written)

Experience in pharmacology and drugs life cycle

Knowledge of ICH-GCP

Strong analytic and quantitative background

Excellent Microsoft Office Skills

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