Inde 11.02.2020

Senior Clinical Data Manager

Tasks

Manages and conducts oversight of CRO deliverables (technical & data) to ensure they are in line with the strategy.

 

  • First point of escalation for the study teams where the Study Data Manager at the CRO is the first point of contact at a study level. Understand, mediate and solve complex issues related to DM deliverables and escalate as required.
  • Act as advisor to the Study Lead on the data management strategy from protocol to delivery of the clinical database.
  • Provides input to study design, the clinical protocol, study planning and review of study documents. Ensures training on the protocol to the CRO resources working on the study.
  • Responsible for managing the outsourced data management activities during the execution phase and ensuring that they are delivered as mutually agreed with the study teams.
  • Responsible for leveraging the learnings (success or failure) after study execution to implement, in their area of responsibility, or propose, improvements for the future.
  • Provide reports, risk management plans, status updates, feedback and advice to key stakeholders on study progress. Provide input into CRO Governance, budget control and resource forecast to the Performance and Outsourcing Manager.
  • Ensure Data Management deliverables are in compliance with Company SOPs and regulatory guidelines.
  • Develop and maintain excellent professional relations with the clinical teams and other key stakeholders

Requirements

Master degree in Life Sciences or data processing with at least 5 years of Data Management experience.

  • Experience with Data management concepts and processes
  • Experience with EDC systems
  • Medidata Rave
  • Capacity to interface with clinicians, statisticians and statistical programmer in charge of a clinical trial.
  • Ability to interact and align with stakeholders
  • Ability to work complying to the company SOPs, data standards
  • Able to read, write and speak fluently in English. English writing skills are a must for this mission regarding developing user guide and define for the review package
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