Start-Up and Operations Support Associate

Start Up and Operations Support Associate

Location:  Flexible location in Barcelona, Munich, London, Rome and Lyon

ICON are currently offering a few opportunities for entry level candidates in the role of Start Up and Operations Support Associate based at various locations across the EU namely Barcelona, Munich, London, Rome and Lyon.   Working within our Real World Evidence team, you will work with a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices. 

Combining the industry’s oldest and most experienced Clinical Outcome Assessments (COA) consultancies (Mapi & Oxford Outcomes), within ICON Commercialisation and Outcomes, and with access to more combined COA experience than all other CROs and consultancies, we can offer fantastic career opportunities. We provide a dynamic, stimulating and rewarding working environment for ambitious and passionate individuals looking to join a global, world-class consultancy business.

Your Responsibilities and Accountabilities:

The Start Up and Operations Support Associate is responsible for actively supporting and participating in the start-up and other project related activities within the Regulatory Affairs and Operations support Department , in accordance with study protocol or available project support documents, applicable guidelines, regulatory requirements and SOPs.

Responsibilities:

In the role of Start Up and Operations Support Associate, you will be:  

• May actively participate in the development of project specific procedures and documents related to feasibility studies.
• May ensure optimal selection of sites, according to the protocol with the project team and, when applicable, in collaboration with the sponsor.
• May be responsible for, or participate to the maintenance of internal Investigator data base.
• Liaises with Regulatory Affairs Department concerning regulatory, ethics submissions and contracting to ensure smooth start-up as appropriate.
• Liaises with Monitoring and Site Management (MSM) Department concerning sites' listing, identification and operational execution.
• When  necessary  coordinates  SMA  and  CRA  activities  for  feasibility  studies  and  other activities as assigned within the Regulatory Affairs and Site Contracts department.
• Responsible for ensuring the timely collection,  review  and  submission   of  essential documents, as required.
• May participate to the completion of regulatory submissions and notifications in support of an assigned Regulatory Specialist.
• May act as a back-up for a Regulatory Specialist for assigned tasks.
• Responsible for providing  status  reports to the  assigned  project  manager,  Clinical  Trial Lead, Regulatory/Contracts Specialist and/or to the sponsor, as required.
• May participate to the Quality Control of the Project Master File (PMF) and audit preparations, as well as provide assistance to the Records Management team for filing and tracking documentation when required.
• Liaises with Monitoring Resources team concerning SMAs/CRAs related topics.
• When qualified, may carry out CRA/SMA tasks for assigned activities and sites. 

You will have: 

• Education to degree level
• Strong knowledge of ICH/GCP guidelines or other relevant guidelines (GEP, GPP or local requirements)
• Proficiency with computer systems
• Strong verbal and written communication skills
• Strong organisational, time management, interpersonal skills.
• Ability to work both independently and in a team environment.

This is a role for someone with some prior experience of working for a CRO / Pharma company with prior exposure to working in or with regulatory and / or site contracts teams.

Next Steps:

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON Plc is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.