Senior Study Delivery Lead - VACCINES - Remote Based in US or CANADA

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.

Qualifications

What do you need to have? Education:
  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
Required skills
  • 5 years of relevant experience
  • Minimum 3 years of experience in clinical research, including a management role as a team lead or project manager experience.
  • Reads, writes and speaks fluent English; fluent in language of host country.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa statusBenefits 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.

Responsibilities

What will you be doing? As a Study Delivery Lead, you are accountable for planning and leading the delivery of a study to time, quality, budget, company standards and scientific requirements outlined in the clinical study proposal (CSP) which aligns to the Clinical Development Plan (CDP) / Integrated Evidence Plan (IEP). The SDL leads the study delivery team of functional subject matter experts and functions as the (etrack) Study Accountable Person for all ICH GCP and SOP-driven activities. In the outsourcing delivery model, the SDL accountability will include effective oversight principles for the delivery of studies or programs that are outsourced to preferred CROs.
  • Coordination of full feasible Study Protocol
  • In partnership with the lead physician, Clinical Scientist and all study team members, accountable for the co-ordination of full, feasible study protocol development that aligns to the CSP and CDP/IEP and can be feasibly implemented in the clinical and regulatory environment of participating regions to provide quality data and ensure timely study delivery
  • Oversight of delivery quality
  • Lead escalation and resolutionf any issues with CRO/ vendors/ site/ country performance raised by the study team, including serious quality incidents and serious breaches of GCP. The SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the absence of Asset Lead).
  • In outsourced studies escalation points will include CRO suppliers
  • Maintain regular interaction with all study team members to ensure issues / risks / successes with study delivery are reviewed and/or shared as they
  • In addition, in outsourced studies:
  • Lead key discussions with CRO suppliers to ensure appropriate expectations have been set and CRO are aligned on delivery strategy
  • Embed a culture of empowerment and accountability for CRO to resolve study issues internally, raising to exception
  • Encourage CRO to take accountability for quality data delivery
  • Provide holistic oversight of CRO - understand study contribution to program/submission
  • Delivery of study to plan
  • Implement innovative approaches to study delivery through external facing advances in tech and sciences
  • Accountability for study delivery strategy (e.g. country selection, diversity, patient engagement strat in collaboration with GICCO and other stakeholders
  • Single point accountability for the operational delivery of clinical study to time, quality and budget (t to completion of TMF archiving)
  • Drive assessment, selection, engagement and management of appropriate vendors for outsourced activities/services; ensures adherence to Oversight Plans and Outsourcing Handbooks as appropriat
  • Ensure innspection readiness for study at all times and overall accountability for eTMF
  • Ensure development, review, finalization and delivery of high-quality key clinical study documents i to meet study timelines
  • Ensure timely, accurate reporting and disclosure of study results (e.g. Clinical Study Reports and C Summary) and archiving of study records
  • May delegate certain responsibilities to Study Delivery Manager(s) assigned to the study Study level risk register, communication, and systems data
  • Ensure that a study level operational risk management plan is in-place and applies a smart-risk taki philosophy
  • Manage internal and external stakeholders through appropriate engagement and communication
  • Provide leadership at study level to ensure accuracy, quality and timeliness of update of operationa maintained in systems used to track studies
  • Ability to lead cross-functional team - set priorities and performance targets in a global environment; effectively plans, co-ordinates and facilitates delivery of study team objectives; understand the accountabilities of study delivery team members and engage & use them to optimum effect; provide the leadership to enable a high performing
  • Creative thinker - able to modernize approach to study delivery
  • Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
  • Effective problem solving and conflict resolution skills with a solutions-oriented mindset Appropriate project management skills
  • Operational expertise in risk management and contingency planning Strong influencing and stakeholder management skills
  • Ability to create a trusting partnership with Clinical science discipline and all study team members
  • Strong communication skills appropriate to the target audience, promoting effective decision-making where necessary
  • Ability to understand and balance the broader business needs with the needs of their specific study In addition, in outsourced studies:
  • Abilitylity to challenge current process to drive towards efficient ways of working to enable CRO to take accountability for quality delivery
  • Ability to influence cross-functional teams (central, regional and LOC) to work collaboratively with CRO to meet project deliverables
  • Partners with peers ensuring consistency (quality, standards, policies, processes and practices


United States-Remote