Operations Associate - Oncology Evidence Network - Multiple locations

About Oncology Evidence Network

About Oncology Evidence Network: The Oncology Evidence Network (OEN) is a collaboration between IQVIA and leading cancer centres across, primarily, Europe. Collaboration with OEN centres is setup to facilitate the delivery of retrospective real-world non-interventional studies, within oncology. The OEN team is a multidisciplinary team of ~20 motivated expert colleagues that contribute to the end-to-end delivery of studies, from the feasibility phase, scientific documentation development, contracting and ethics, through to analysis and reporting.

Job Overview

We are currently seeking an individual to join IQVIA within IQVIA\’s Oncology Evidence Network (OEN) team to support the development of the operations unit and more specifically the contracting and ethics unit. You will be responsible for managing or leading data source contracting and ethics workstreams (site activations) for the team\’s portfolio of retrospective real-world oncology studies, spanning >30 data sources across core European countries and beyond. In addition, you will be responsible for process improvement and implementation to iteratively refine and standardise the contracting and ethics processes across the OEN portfolio of data partners. Further, you will be responsible for identification and implementation of further operational real-world study tasks e.g., data source payments, to ensure further standardisation across delivery of OEN studies. Over time, there is opportunity for wider involvement in OEN study activities, but with the primary focus remaining within the operations unit.

Essential functions

• Developing high-quality documentation to facilitate the ethical approval of OEN studies from relevant ethics committees.
• Responsible for the maintenance activities of ethics committees following approval of OEN studies i.e., maintenance activities and close-out activities.
• Work with translation vendors to facilitate development of local language documentation, where required by ethical committees/data sources.
• Liaising with cross-functional project teams to ensure correct alignment of contracting and ethics related matters with the wider timeline of studies.
• Becoming subject matter expert with the contractual model setup between IQVIA\’s OEN and data partners to ensure correct and efficient completion on a study-specific basis.
• Understanding of contractual principles for data sharing agreements and willingness to further understanding.
• Understanding of data privacy regulation (GDPR) and country-specific interpretations across key European countries, with willingness to deepen understanding.
• Willingness to follow procedural/operational processes with confidence and flexibility to create improvements to processes where required.
• Identifying opportunities for the operations/contracting and ethics function of OEN to expand its tasks (e.g., absorbing the processing of study-related invoices) and to further standardise processes (e.g., standardised template documentation for ethics submissions).
• Ability to work independently with guidance from senior team members, as required.

Qualifications

• Bachelor\’s Degree (Master\’s Degree preferred)
• Demonstrable experience in and commitment to the life sciences and/or healthcare industries
• Experience conducting ethics submissions and data source contracting for retrospective observational studies in at least 1+ core European country
• Detail oriented to ensure first-round approval of studies from relevant ethics committees
• Demonstrable analytical, interpretative and problem-solving skills
• Well-developed written and verbal communication skills including presentations, chairing meetings, workshop facilitation, business and report writing
• Experience working in sizable/ multi-disciplined teams
• Excellent interpersonal skills and ability to work effectively with others in and across the organization to accomplish team goals
• Knowledge of key issues and current developments in the pharmaceutical and healthcare industries
• (optional) Knowledge with the application of data privacy regulations to appropriate data access policies e.g., waiver of consent and ICFs.
• (optional) Knowledge of the regulatory, ethical and data privacy principles spanning core European countries (both local and national requirements) and ability to concisely document this for process standardisation.
• Fluency in English (spoken and written)
• Right to live and work in the recruiting country

Please submit your CV in Englis

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com