Ref #: 32065

Employment type: Permanent - Full-Time

Location: Reading Berkshire Buckinghamshire

Posted: 11-Oct-2021


You will work with a well-established global study management team. You will support the execution of clinical trials in accordance with ICH-GCP and standard operating procedures and collaborate with cross-functional internal and external stakeholders to ensure timely execution of clinical trial deliverables

Key Responsibilities include:
• Contribute to the preparation of training materials (Investigator Meetings, Site Evaluation and Initiation Training)
• Coordinate study-level Investigational Product arrangements, accountability and reconciliation
• Manage process for planning and procuring ancillary clinical supplies
• Facilitate and collate country recruitment plans
• Create and manage study specific tools such as recruitment and retention materials and study newsletters
• Maintain the Study History Document
• Process work requests to Study Management Associate (SMA) team
• Facilitate authoring of Investigational Product Information Manual (IPIM) and study specific Important Protocol Deviation (IPD) list
• Support and oversee vendor activities where assigned
• Work with outsourced vendors to organize and deliver essential documents to the trial master file
• Compile IRB/EC submission documentation
• Assist with Global Development Operations (GDO) Operational Review preparation
• Prepare Clinical Study Team (CST) meeting agendas and minutes
• Manage global versioning and distribution of informed consent forms (ICFs)
• Facilitate cross functional meetings
• Submit documents to trial master file (TMF) and support inspection readiness activities

What is required
• BA/BS/BSc in life sciences or RN or High School Diploma or local equivalent and proven clinical experience
• Ideally 5 years’ Specialist experience working in life sciences or medically related field (i.e., within a biotech, pharmaceutical or CRO company)
• Full and valid UK working eligibility

What is offered
• Permanent and full-time contract of employment seconded 100% to the one sponsor
• Flexible work: 3 days per week in the Reading office and 2 days homeworking
• Salary depending on level of skills and experience plus company benefits (23 days annual leave, pension, healthcare cover, etc.)

To express your interest and full job details, please contact* me at or ring +33 964 25 67 65.

*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.