Offer summary

Qualifications:

Minimum 5 years of experience in the Data Acquisition domain., Scientific background in medical, biological, lab, imaging, or life sciences., Ability to communicate clearly and work autonomously on non-CRF data strategy., Experience in clinical trials and understanding of data management conventions..

Key responsabilities:

Lead the collection of non-CRF data during study activities for multiple studies.

Collaborate with non-CRF vendors to ensure timely and quality data delivery.

Develop study level project plans to ensure timely delivery of non-CRF data.

Communicate data collection deliverables and coordinate cross-functional tasks with stakeholders.

Job description

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

Min 5 yrs of experience in Data Acquisition domain.
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).

Required profile