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.