Clinical Project Associate Reading

Clinical Project AssociateOffice-based in Reading (Berkshire) 3 days per week and 2 days homeworking

As a Clinical Project Management, you will work on project management related activities. You will have the opportunity of working with a well-established global study management team alongside clinical trial managers. You will 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

Knowledge

Ability to understand technical, scientific and medical information

Understanding of the drug development process

Familiar with advanced concepts of clinical research

Experience interacting with external vendors (e.g. CROs, Labs etc.)

Advanced computer skills

Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines and applicable international regulatory requirements

Ability to write and present clearly using scientific and clinical issues terminology

Experience dealing with time demands, incomplete information and/or unexpected events

Good organizational and planning skills

Experience working effectively in a team/matrix environment

Key competencies

Attention to detail

Team work

Proactive and solution orientated

Delivery and risk focused

Demonstrates a strong understanding of risk management

Adaptability and flexibility

Shows Initiative and critical thinking ability

Strong relationship management and influencing skills

Policy, process and procedural conformance

Problem solving skills

Effective time management skills

Demonstrate ability to work effectively cross-culturally and in a virtual environment

IT- strong computer literacy, including word processing, presentation and spreadsheet applications

Business English proficient written and verbal communication skills in English

Excellent communication skills

Good organizational and planning skills

Experience working effectively in a team/matrix environment

Proactivity

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 with 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 find out more details please contact me!

Benefits of working with ICON

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. Thats 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, colour, 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.

Posted
05/01/2022
Location
Berkshire, England, UK