Data Acquisition Specialist

1 month ago

Bengaluru, India Parexel Full time

When our values align, there's no limit to what we can achieve.
 

SKILLS

● Able to understand complex interdependencies.● Communicate independently, proactively and clearly to internal and external stakeholders, able to work autonomously on the non-CRF data strategy for the study team.Take ownership of non-CRF data.● Identify risks and suggest mitigation plans.● Influence the study team to adhere to (non-CRF principles) and processes, speak up and challenge where necessary.● Negotiate contingency plans to mitigate delays of deliverables.● Can demonstrate curiosity for data and be able to learn fast and think smart.● Scientific background in at least one of the following: medical, biological, lab, imaging, life sciences.● Comfortable with working across multiple platforms and tools.● Experience of clinical trials.

TASKS

● Leads the collection of non-CRF data, during study set-up, conduct and close out activities for multiple studies, contributing to fit for purpose data quality.Including IxRS data loaded into the eCRF.● Close collaboration with the non-CRF vendors/data providers to set up data transfer agreements and ensure timely and quality non-CRF data delivery.Come to mutual agreements and intelligently negotiate with the vendor and study team to be able to deliver what the study needs.● Selects and implements appropriate study conventions including non-CRF data collection standards, processes, knowledge sharing and best practices on assigned study(s).● Proactively develops study level project plans (including contingency plans) to ensure timely delivery of quality non-CRF study data to support project milestones.● Represents DSD on Study working groups or sub-teams and works with the study team to develop and implement specifications and processes related to non-CRF vendors/data providers.● Effectively communicates non-CRF data collection deliverables, status of work and data issues to the DQL and other study team members.Coordinates cross-functional non-CRF tasks with strong understanding of downstream processes and stakeholder needs and impacts.● Identifies the need for new processes and guidance documents.● In-depth understanding of the business of his or her discipline and the wider DSD organization.● Understand the conceptual basis for data management conventions, standards and processes.● Good understanding of the role of data management, biostatistics, statistical programming and the study team in the drug development process.●Understands compliance, regulatory principles and follow GxP requirements (SOPs, Policies etc).

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