As a Project Manager, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This is a permanent and home-based role employed through ICON and sponsor dedicated to our client.
What you will be doing:
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.
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 by exception.
Encourage CRO to take accountability for quality data delivery.
Provide holistic oversight of CRO – understand study contribution to program/submission.
You are:
BSc or MSc graduate.
Must have strong clinical trial management experience.
Able 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.
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.
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 LOC) to work collaboratively with CRO to meet project deliverables.
Partners with peers ensuring consistency (quality, standards, policies, processes and practices) across the outsourced portfolio.
Why 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.
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.
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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
#J-18808-Ljbffr
