Investigator Initiated Trials (IIT) Program Manager EMEA - Geneva
Inseriert am: 16.04.2020
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Job ID286912BRPosition TitleInvestigator Initiated Trials (IIT) Program Manager EMEA - GenevaApply to Job
Job Description
Alcon are one of Europe’s ‘Top Employer’s’ and are 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!
Role Overview
In direct collaboration with Director Medical Operations and the two field Medical Area Heads, the IIT Program Manager will oversee the IIT/IIR portfolio. Ensure review and support to the Field Medical Advisors (FMA) when required to prepare project reviews at the regional level and preparation for board submissions and presentation. Fully responsible for IIT/IIR portfolio tracking and reporting ensuring adherence to Alcon SOP and regulation
You will be a key partner for FMA in IIT at all stages – internal customers & external upon needs 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 GOC, 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
• 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 requirements
- Experience in clinical research, clinical studies / clinical project management is required to be fully operational in the position
- Proficiency in Good Clinical Practices
- Experience in Medical Device industry preferred
- Experience in ophthalmology is a plus
- Organisation and Project management skills
- Process driven, compliance-focused candidate
- 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.
- Knowledge of Medical Devices Regulation and ISO14155 standard (a plus)
- MS office proficiency and other digital tools
- English fluency: mandatory. Fluency in another EU language is appreciated Education Scientific degree (PharmD, PhD, MD preferred, MSc with relevant professional experience)DivisionALCONBusiness UnitNON-NVS AL RESEARCH & DEVELOPMENTLocationSwitzerlandSiteGenevaCompany/Legal EntityAlcon Management SAFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularShift WorkNo
