Operational Compliance Officer

Operational Compliance Officer

Global Oncology Site Network

Discretionary Bonus Scheme

Introduction

At ICON, it's our people that set us apart.

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

As a global provider of drug development solutions, our work is a serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

Our Oncology Site Network, Oncacare, 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.

This is an excellent opportunity for an Operational Compliance Officer to play an important role in driving our organisation towards success.

The Operational Compliance Officer will be responsible to the Head of Operational Compliance.

Main Responsibilities:

• Be responsible for supporting quality operational activities across your designated Research Sites.

• Ensure that the Quality Research Sites within your remit are audit and inspection ready at all times by conducting Operational Compliance visits to confirm adherence to ICH GCP, SQMS and local Regulations.

• Ensure that operational compliance visits also include the verification of implemented CAPA previously agreed from reported quality issues and review of Monitors feedback.

• Plan and Report of Operational Compliance activities in your designated Research 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 CEO/CMO/Head Of Operational Compliance)

• Matrix Manager for Data Coordinator's, identifying procedural and process gaps and addressing them to achieve compliance excellence.

• Perform compliance checking of Oncacare controlled documents and provide feedback and support to colleagues.

• Develop relationships with Head Office and site teams providing advice on operational and training requirements.

• Act as the point of contact for compliance matters at site level, providing information and expert guidance on regulations and procedures.

• Review and analyse audit report findings to identify trends and suggest process improvements.

• Ensure industry and relevant quality assurance knowledge is updated on a regular basis; share leanings with Quality team.

• Perform any other duties as required to support the Site team and wider Oncacare business.

To be successful you will need:

• Ideally educated to degree level in a life sciences discipline or possess significant/relevant experience.

• Minimum 1 years' experience in a Clinical research role within a Site Management Organisation, Clinical Research Organisation or Pharmaceutical business.

• Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.

• Knowledge of maintaining and improving quality systems and procedures.

• Exposure to client audits and regulatory inspections, ideally in a Quality role.

• A demonstrated commitment to quality in a regulated environment.

• Ability to work independently, with minimal supervision, and be confident to make local decisions and escalate accordingly.

• Willingness to travel regionally on a regular basis.

• Exceptional customer services skills to both internal and external stakeholders.

• Preferably experience of preparing an analysing data and Quality Metrics.

• Knowledge of international GCP regulations and regulatory inspections.

• Personal profile

• Be highly organised with a focus on quality and detail.

• Self-motivated with a high level of initiative.

• Assertive and persistent with a high degree of flexibility.

• Excellent communication and interpersonal skills and the ability across the organisation at all levels

Why join us?

Ongoing development is vital to us, and as an Operational Compliance Officer at Oncacare, our Global Oncology Site Network, 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.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment