Alcon is one of Europe’s Top Employer’s’ and the market leader in eye care globally, helping people see better through advanced surgical and vision care products so if you want to help make a difference then please join us!
In direct collaboration with the Director Medical Operations and the two field Medical area heads, the IIT Program Manager will oversee the IIT / IIR portfolio.
Responsible for coordinating new project reviews at the regional level and supporting the Field Medical Advisors (FMA) preparation for board submissions and presentation.
Fully responsible for IIT / IIR portfolio tracking and reporting, and adherence to Alcon SOP and regulation.
You will be a key partner for FMA in IIT at all stages and we are seeking those who are strong communicators with the ability to make strategic decisions as well as work collaboratively within a team environment.
Key Responsibilities :
IIT / IIR portfolio management : Oversee and maintain the IIT databases and portfolio reporting presentations. Ensure completion of the IIT Trial Master Files, track IIT implementation and project status until completion
IIT / IIR reviews : Oversee IIT documentation for successful submissions, develop and implement relevant templates and tools for facilitating tracking, submission, reviews and follow-up of projects until completion.
Facilitate projects reviews at regional level, and international level, coordinate submission to boards reviews, assisting the FMA when required
IIT / IIR Process : Follow-up and maintain regional IIT processes, guidelines, forms and tools and drive continuous improvement by alignment of relevant stakeholders globally and locally.
Ensure IIT budget reviews according to Fair Market Value
IIT / IIR reporting : Track KPIs to measure efficiency of review process and success in portfolio management and projects completion per plan, Identify gaps and mitigate risks for sustainable IIT operations
IIT trainings : Coordinate dissemination of IIT training materials, facilitates training sessions for key IIT roles in the region, including FMA.
Support IIT trainings to HCP
IME : support IME regional management (grant request preparation for compliance committee review)
Minimum 3 years of experience in investigator initiated trials and / or clinical studies / clinical project management is required to be fully operational in the position
First experience as clinical research associate is a plus
Proficiency in Good Clinical Practices ISO14155 and Medical Devices Regulation
Experience in Medical Device industry preferred.
Experience in ophthalmology is a plus
Biostatistical knowledge is a plus
Strong Organisation and Project management skills
Process driven, compliance-focused candidate, and attention to details
Transparent communicator and team work attitude
Capacity to work and easily communicate in a multicultural environment, directly or remotely
High energy, hands-on individual with a collaborative personal style and the ability to work well in a team environment.
English fluency : mandatory. Fluency in another EU language is appreciated
Scientific degree (PharmD, PhD, MD preferred, MSc with relevant professional experience can be considered)
Why join Alcon?
We aspire to lead the world in innovating life-changing vision products because when people see brilliantly, they live brilliantly.
We are the world’s leading eye care products and devices company. You will join our 20,000 associates at Alcon, making a real difference to the lives of others.
At Alcon, we create meaningful opportunities for associates to grow their careers. Learn more at www.alcon.com.
Our Purpose is Reimagining Eye Care.
Our Vision is to be the trusted leader in eye care.
Our Mission is to discover new ways to enhance sight and improve people’s lives.