Oncacare (France) S.R.L. - Global Oncology Site Network

Data and Compliance Officer (Mobile)

Full Time, Permanent

Bordeaux, France

Predominantly homebased but travel (approximately 60% and at short notice) domestic and/or international to other sites within the network may be required to support increases in workload and, or studies/projects as needed.

Introduction

Are you looking for an outstanding opportunity to develop your career with ICON’s leading edge Global Commercial Oncology Site Network which is growing fast?

Oncacare, in partnership with ICON Plc, is an Oncology Site Network which concentrates on developing high performing sites by accelerating start-up timelines and focussing on high level of patient enrolment with strong attention to data and quality standards. These qualities are what our Sponsors look for in a leading Oncology Site Network and you can be part of our success story. We are growing our international footprint and you can play a part in our expansion and be involved in the future of oncology treatments across the globe.

Oncacare is passionate about transforming cancer research to advance new treatments. Our strong capabilities enable us to bring together Patients, Sites and Pharmaceutical organisations to present a unique solution to the cancer trials industry. The Oncacare global site network provides opportunities for patients and oncologists to advance the development of cancer treatments more quickly and efficiently.

We are a change agent for cancer clinical research.

Quality, Patient Centricity, Delivery, Staff and Prospects are our principal values at Oncacare. They are fundamental in shaping the way in which we work and map out our future. By working to these values, we can achieve our objectives and ensure our teams are fully engaged, patients are enrolled and trial results are consistently realised from our customers.

This is an excellent opportunity for a Mobile Data and Compliance Officer with exposure to CROs, Research Sites and Networks to play an implemental role in driving our organisation towards success.

As a Mobile Data and Compliance Officer, you will be accountable for ensuring all data generated at site has been processed and entered accurately into electronic systems within the set timelines. You will also be responsible for operational compliance at site level.

Main Responsibilities

Data Management Activities

• Transcribing all data generated at site into electronic systems within the set timelines.
• Maintaining, filing and organising patient source notes and any associated data and files.
• Maintaining, filing and organising Investigator site files and associated documents.
• Ensure all folders are up to date, correctly labelled and stored securely and in an organised manner.
• Resolve queries generated by sponsor representatives and electronic systems within the set timelines.
• Liaise with relevant members of the clinical team to resolve queries and improve data quality.
• Maintain high quality standards by regularly checking data for any discrepancies.
• Provide review of source data worksheets during study start up and throughout study.

Operational Compliance Activities

• Be responsible for supporting quality and operational compliance activities across your designated clinical sites.
• Ensure that operational compliance visits also include the verification of implemented CAPA previously agreed from reported quality issues/audits and review Monitors feedback.
• Plan and Report of operational compliance activities in your designated clinical sites; providing a detailed summary of findings that include data analysis of trends, risks and suggested actions to address risk areas. communication and management of quality issues with internal partners, (including but not limited to COO/CMO/Head of Quality Assurance)
• Perform compliance checking of Oncacare controlled documents and provide feedback and support to colleagues.
• Act as the point of contact for compliance matters at site level, providing information and expert guidance on regulations and procedures.

To be successful you will need:

• Minimum 1 years’ experience in a Clinical research role within a Site Management Organisation, Clinical Research Organisation or Pharmaceutical business.
• Qualification - BSc or MSc preferably in science or biomedical fields.
• Exposure to client audits and regulatory inspections, ideally in a Quality role.
• Excellent communication and interpersonal skills and the ability across the organisation at all levels.
• Bilingual - English with another European language is advantageous.
• Able to travel at short notice (up to 60% travel may be required).
• IT skills - fluent and familiar with IT.
• Attitude - passionate.
• Excellent interpersonal skills and telephone manner.
• Pro-active, flexible and able to multi-task.
• Good organisational skills with attention to detail.
• Able to work under pressure and to deadlines.

Why join us?

Ongoing development is vital to us, and as one of the Data and Compliance Officers at Oncacare, you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

We are an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.

Visit us on www.oncacare.com

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