Icon plc is a world-leading healthcare intelligence and clinical research organisationFrom 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 successIcon people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
What will you be doing?
In pharmacovigilance & patient safety, the safety project manager (spm) is responsible for owning and achieving successful interim and final contractual deliverables on assigned global, pvs stand alone projects/programs, according to the time, quality, scope and cost constraintsThe spm leads and directs cross-functional teams, understands and manages client expectations/needs to achieve client satisfactionThe spm proactively identifies, escalates, resolves/mitigates, risks and/or issuesThe spm adheres to pra standard procedures and processesThe spm serves as a pvs representative during the business development process.
Responsibilities include:
Acts as primary liaison with client:
Acts as lead contact for regional and or/project matters.
Understands/manages/satisfies client contractual, organizational and relationship needs/expectations.
Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated management plan to client.
Chairs and leads client meetings.
Leads and directs cross-functional team leaders and third parties/vendors with some supervision and support:
Contributes to development, maintenance and approval of project plansGuides and supports team leads in prioritizing, trouble-shooting and contingency planning.
Delegates whilst retaining ownership.
Communicates project specific priorities.
Liaises with functional leads/managers to optimize performance and utilization of project team members.
Manages project contractual deliverables:
Supervises progress via metrics.
Monitors and ensures adherence to the contractual agreement (time, quality/scope, and cost deliverables).
Leads presentation of internal project status reviews and is accountable for action item follow up.
Proactively identifies, resolves/mitigates and escalates risks and/or issues.
Manages project costs:
Owns projections of units/hours (revenue and resources), actual units/hours efficiency analysis.
Proactively and timely identifies, for assigned projects, ensuring out of scope activities are approved upfront via a contract modification.
Identifies potential or actual unrecoverable hours and provides analysis and mitigation/resolution plan for senior management’s approval.
Ensures control of financial risk to pra.
In cooperation with the project analyst, applies efficient management of project pass-through costs and investigators payments to ensure all such costs are recovered in a timely manner, and in advance where ever possible.
Leads presentation of financial reviews and is accountable for action item follow up.
Ensures adherence to company sop, policies and guidelines at the project level.
Assumes project leadership role in compliance at project level to pra processes and systems including escalation to relevant functional and operational management.
Participation and attendance in bid defense process.
Provides feedback on project team member’s performance to respective line-managers.
Qualifications
What do you need to have?
Level 2
Required
An undergraduate degree or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job
4+ years of experience in pharmacovigilance
2+ years’ experience of single service project management, including the following: working with large, unit based budgets with multi service scope, forecasting, working with cross functional, global project teams
Clinical trial and post marketing experience
Strong communication skills
Able to manage client expectations
Reads, writes and speaks fluent english; fluent in language of host country.
To qualify, applicants must be legally authorized to work in the prospective country, and should not require, now or in the future, sponsorship for employment visa status.
***this position is remote and is based in the united states***
Benefits of working in icon:
Our success depends on the knowledge, capabilities and quality of our peopleThat’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 programsIn 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 harassmentAll 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.
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