20 Oct
Medtek.AI
Kottayam
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
3 to 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
▶️ Clinical Data Manager
🖊️ Medtek.AI
📍 Kottayam