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Clinical Project Associate

Employer
ICON Strategic Solutions
Location
Reading, Berkshire (GB)
Salary
upon application
Start date
1 Jun 2022
Closing date
1 Jul 2022

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Clinical Project Associate II

Office-based in Reading (Berkshire)

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

 

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:  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 for 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. 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, 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.

Company

As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.

ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.

Why choose a career with ICON Strategic Solutions?

Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.

Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.

Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.

Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.

Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.

Company info
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