Ref #: 30759

Employment type: Permanent - Full-Time

Location: Buckinghamshire

Posted: 05-Aug-2021

Description

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.


The Clinical Trial Manager role and main responsibilities are:
• Leading the regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan
• Identifying and resolving issues at a regional level
• Collaborating with Global CTM to ensure country level study delivery is aligned with the global study project plan
• Contributing to study-level risk assessments
• Leading and continually review regional risk mitigation activities to ensure study delivery to plan
• Overseeing regional insourcing/outsourcing partner deliverables to the required standards
• Ensuring regional, country and site vendor set-up, conduct and quality e.g. laboratories and equipment provisioning
• Leading regional documentation and required tool and systems set-up
• Contributing to regional aspects of Drug Supply Plan
• Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines
• Supporting audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate
• Executing regulatory agency inspection readiness activities (e.g. TMF review, story board generation) within region
• Supporting and contributing to Clinical Study Team(s)
• Ensuring relevant systems are updated to enable accurate reporting of study progress and milestone deliverables
• Ensuring key stakeholders are kept informed of study progress e.g. Global CTM, DOMs
• Contributing to development of study-specific materials e.g. monitoring plan, study specific training documents
Participation in cross-functional task forces / process improvement groups

To be successful in the role, you will have:
• BA/BS/BSc in the sciences or RN
• Ideally 7 years work experience in life sciences or medically related field, including preferably 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company.
• Experience in oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)

What is offered
• Permanent and full time contract of employment seconded to our client
• Office-based in Southampton (Hampshire / UK) 3 days per week with 2 days homeworking flexibility
• Great scope to develop your career further
• Salary will depend on level of experience and skills
• Structured on-boarding for all new joiners with company benefits to include annual leave, car allowance, and more.

For more information, please contact me at Elisabeth.Knighton@DOCSGlobal.com


Benefits of Working in ICON:
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.

#pmjob