Clinical Scientist - Home-Based

Overview

As a Clinical Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
• Contribute to end-to-end delivery of clinical development strategy.
• Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
• Actively partner to build relationships and collaborate with oncology aligned staff in other global functions.
• May support regulatory interactions, including contributing to briefing documents, presentations, addressing questions and responses.
• Responsible for cultivating strong relationships and robust communication among the GSK clinical study/project team and the Divestment team. This includes training, education, onboarding as well as problem solving in the conduct of clinical trials.
• Develop solutions by encouraging others within matrix and line teams to seek alternative perspectives.
• Study design and interpretation of study results that provide data to adequately address questions concerning efficacy/effectiveness, safety, applicability to targeted patient population, and clinical and commercial value that are consistent with the compounds’ phase of development while ensuring that patient safety is of paramount concern and that regulatory requirements are incorporated through:
• Accountability for Study Team members/stakeholders, as appropriate and regulatory reporting at the study level by providing leadership at study level to assure overall safety of the study subjects.
• Drive/Contributing to clinical components of the IB/DSUR/protocols, and documents for regulatory submissions and advisory requirement.
• Serves as a product, protocol and project subject matter expert to support internal and external customers.
• Work with external experts to develop abstracts, manuscripts and study design presentations.

Qualifications

• Bachelor’s degree in life sciences or related discipline, 3~5 years of experience
• Experience in a pharmaceutical industry or CRO environment in the clinical development process
• Oncology clinical development experience, particularly in the area of immuno-oncology, even more particularly in Cell Gene Therapy (preferred, not a requirement)
• In depth knowledge of study management, global regulatory guidelines and ICH/GCP
• Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports
• Proven track record of working with investigators, site staff, external experts, CROs and vendors
• Excellent leadership skills

Preferred Qualifications:

• Advanced degree (e.g. MS, PhD, PharmD)
• Clinical development experience across all phases of development (I-IV).
• Highly developed communication skills appropriate to the target audience, promoting effective decisionmaking where necessary
• Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
• Excellent influencing and negotiation skills

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich di