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.
This role is remote and can be based in UK, Poland, Germany, Spain, Romania, Bulgaria and Italy.
The Senior Study Delivery Lead (sSDL) is the Global Project Manager of a study.
As such, the sSDL is accountable to ensure that the study team is planning and executing the study according to time, budget and quality and as defined in the Development Plans (Clinical, Epidemiology, Global and Local studies), in the study management plan, in the study protocol, and in adherence with ICH-GCP guidelines, company's control documents and within regulatory requirements.
The sSDL is 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 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.
The sSDL has the accountability for 1 or several complex studies, and has the ability and the seniority to manage the delivery of any types of studies (different areas, complex/unusual early setting, new/unusual indication, pivotal / Phase III and efficacy studies, clinical as well as epidemiology and local studies, complex countries/regional environment).
The sSDL is able to develop and follow the most efficient operating model for supported/collaborative studies, to manage appropriately the risks linked to supported/collaborative studies and has experience and skills to manage all associated requirements – Same for the management and oversight of outsourced studies (including RFP/Bid defense and contract management).
The sSDL is able to manage large & multidisciplinary study team (up to 30 team members) and manages studies with a budget that can be >10 M€ with more than 15000 human subjects for studies.
The sSDL may have the responsibility for a clinical development sub-program and therefore can be contributor to the program strategy development and program delivery oversight.
The sSDL is the reference and role model within study delivery lead team.
Principal Responsibilities:
- 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 resolution of 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 occur.
- In addition, in outsourced studies:
o Lead key discussions with CRO suppliers to ensure appropriate expectations have been set and company/CRO are aligned on delivery strategy
o Embed a culture of empowerment and accountability for CRO to resolve study
issues internally, raising to GSK by exception
o Encourage CRO to take accountability for quality data delivery
o 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 strategy 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 appropriate
- Ensure inspection readiness for study at all times and overall accountability for eTMF
- Ensure development, review, finalization and delivery of high-quality key clinical study documents 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 taking philosophy
- Manage internal and external stakeholders through appropriate engagement and communication
You are a creative thinker - able to modernize approach to study delivery!
Minimum Level of Job-Related Experience required >8 years of significant experience in managing complex clinical research studies, clinical operations or equivalent.
Very good understanding of the clinical research and clinical trial management, associated regulatory, processes and quality requirements are essential.
- 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 team.
- 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:
- Ability 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 local) to work collaboratively with CRO to meet project deliverables.
- Partners with peers ensuring consistency (quality, standards, policies, processes and practices) across the outsourced portfolio
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.
.jpg)
.png)
.jpg)
