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).
Top Skills
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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