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When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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).
