Description

As a Project Manager (investigator initiated studies) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:
• Oversee and ensure tracking receipt of proposals from Investigator Sponsor
• Facilitate and oversee communication with Sponsor via collaboration with Medical POC (e.g. acknowledgement of receipt of proposal, provision of scientific comments on protocol)
• Complete sponsor qualification process (in collaboration with Medical POC as needed)
• Ensure execution of Confidential Disclosure Agreement where necessary
• Facilitate team review process for proposals, protocols and amendments and submit for review by Medical POC/GMAL or review committee e.g.: KEG, GISS PRC
• Facilitate or support meetings internally (e.g. product-specific ISS or Pre-KEG review meetings, EGT, Finance, DSP) and with Sponsor as appropriate (creating agendas, minutes, etc)
• Ensure provision of protocol submission package to sponsor, including product specific safety information, details of sponsor’s ISS process and requirements for protocol review and start-up activities
• Partner with Global /Regional Operations representative regarding drug forecasting, clinical trial labeling activities, and expiry dates/memos as appropriate
• Partner with GCP&P on budget negotiations and to ensure conduct of Fair Market Value assessment
• Collaborate with Medical POC to notify Sponsor of any actions or information required from Due Diligence process
• Initiate and support the contract execution process in collaboration with LAW
• Ensure collection of ISS Initiation Package (ISSIP) documents and forward for signature approval
• Oversee and ensure updates to relevant source systems (e.g. milestone tracking, enrolment status)
• Oversee and ensure tracking and archiving of essential documentation in Central Document Repository
• Procure updates from the Sponsor regarding enrolment, milestone payments, etc, per contract and approve invoices and payments per contract
• Ensure the provision of safety updates to Sponsor in collaboration with Safety

You are:
• *
• BA/BS/BSc in the sciences or RN
• 5 year’s work experience in life sciences or medically related field, including 5 years of related experience (project management experience)
• Experience obtained working on investigator-sponsored trials
• 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.

Responsibilities

• Oversee and ensure tracking receipt of proposals from Investigator Sponsor
• Facilitate and oversee communication with Sponsor via collaboration with Medical POC (e.g. acknowledgement of receipt of proposal, provision of scientific comments on protocol)
• Complete sponsor qualification process (in collaboration with Medical POC as needed)
• Ensure execution of Confidential Disclosure Agreement where necessary
• Facilitate team review process for proposals, protocols and amendments and submit for review by Medical POC/GMAL or review committee e.g.: KEG, GISS PRC
• Facilitate or support meetings internally (e.g. product-specific ISS or Pre-KEG review meetings, EGT, Finance, DSP) and with Sponsor as appropriate (creating agendas, minutes, etc)
• Ensure provision of protocol submission package to sponsor, including product specific safety information, details of sponsor’s ISS process and requirements for protocol review and start-up activities
• Partner with Global /Regional Operations representative regarding drug forecasting, clinical trial labeling activities, and expiry dates/memos as appropriate
• Partner with GCP&P on budget negotiations and to ensure conduct of Fair Market Value assessment
• Collaborate with Medical POC to notify Sponsor of any actions or information required from Due Diligence process
• Initiate and support the contract execution process in collaboration with LAW
• Ensure collection of ISS Initiation Package (ISSIP) documents and forward for signature approval
• Oversee and ensure updates to relevant source systems (e.g. milestone tracking, enrolment status)
• Oversee and ensure tracking and archiving of essential documentation in Central Document Repository
• Procure updates from the Sponsor regarding enrolment, milestone payments, etc, per contract and approve invoices and payments per contract
• Ensure the provision of safety updates to Sponsor in collaboration with Safety

Qualifications

• BA/BS/BSc in the sciences or RN
• 5 year’s work experience in life sciences or medically related field, including 5 years of related experience (project management experience)
• Experience obtained working on investigator-sponsored trials

Benefits

• 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