ICON Clinical Research

Clinical Trial SME Lead

27 Jul 2021
25 Aug 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

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.

Firecrest Clinical is part of the ICON plc Group and produces highly visual and engaging products for the Clinical Trial Industry. Firecrest products help improve Site performance by delivering innovative and effective training to sites while complying with Industry Standards. As an organisation responsible for the development of clinical training for medical staff, the Content and Functional Reviewer role is critical to the delivery of accurate and high quality training products to our clients.

The Role:

The CT SME Supervisor is a critical role providing management, scientific and clinical oversight across the entire operational unit within Firecrest organisation, the work of CT SMEs in the CT SME team and acting as a clinical point of contact for our clients and teams.

Firecrest's reputation is critically linked to the accuracy and applicability of our medical offering and its regulatory compliance across the development spectrum (early phase to phase IV). The CT SME Supervisor will familiarise themselves with the relevant protocols, and other client study material and provide oversight and input into all Firecrest projects / services offered, being available to impart clinical and scientific knowledge for each sponsor we service.

The CT SME Lead will contribute actively and substantially, providing direction and guidance on the operational components of our products across the full Firecrest portfolio to ensure efficiencies, quality and scalable mechanisms are operationalized. They will also be responsible for ensuring that our products meet the sponsor requirements.

The CT SME Lead will be involved in supervising and providing direction to the team across all areas including project requirements, quality review issues, on-time completion of projects and team metrics.

The CT SME Lead will evaluate and provide guidance on new products offerings from Firecrest to ensure that they are compliant with all regulations using leading edge technologies/processes and meet a true clinical need.

Along with other members of the Firecrest Management Team, the CT SME Supervisor will represent Firecrest externally with key stakeholders when required

  • Recognize, exemplify and adhere to ICON's values that centre around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • As CT SME Supervisor, the employee is expected to recognise the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Act as a resource to the company as a whole and particularly to Firecrest CT SME team.
  • Provide clinical and scientific input to global product development and business development teams and provide operational expertise in the review of product releases.
  • Strengthen clinical knowledge of staff and serve as a resource for clinical information to Firecrest staff and initiatives.
  • Advise product development team on features and usability and educate project teams on clinical and scientific rationale.
  • Manage departmental performance against agreed targets and budgets, and within policies and standards ensuring that all projects are in keeping with approved timelines and budgets, with potential obstacles identified and solutions implemented to avoid delays in project implementation.
  • Prepare monthly Performance Metrics to measure product accuracy; develop and implement strategies to ensure continued success.
  • Provide the planning and management to the Firecrest CT SME team by ensuring that appropriate structures, systems, competencies and values are developed in conjunction with the Snr. Mgr. Pharmacologist and ensures that projects are conducted in accordance with applicable regulatory requirements and guidelines.
  • Ensure that the interfaces between the CT SME team and other departments are managed optimally.
  • Oversee and direct the work of the CT SME team, ensuring that it is of the highest standard; consistent with the agreed approach, in line with the style guide, instructionally effective, and engaging*
  • Build and motivate a high-performing CT SME team, by developing and retaining high-calibre staff to the company in order to continue to meet Firecrest's quality requirements into the future.
  • Strong knowledge of clinical trials, with experience in working with investigator sites.
  • Ability to lead others in order to move internal teams towards achieving goals that support Firecrest's key strategic accounts.
  • Strong analytical and business acumen skills and strong creativity skills; focused and disciplined.
  • Strong presentation skills; experience speaking publicly and/or presenting to existing or potential clients on topics related to Firecrest.
  • Comfortable working both internally and externally with technical and medical experts providing input into future product strategies.

  • Science or Healthcare-related Degree or equivalent
  • 2+ years of experience in Contract Research Organisation or a pharmaceutical or biopharmaceutical company, leading multiple multinational clinical trials and successful product approvals.
  • Experience monitoring and overseeing clinical trial projects.

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 through the form below.