This is an exciting opportunity to join ICON
ICON Study Start-up Services are building for a forward-thinking future. Site activation is currently one of the most challenging aspects within the project lifecycle.
Due to the fast nature of the business Study Start Up works within, we're looking to develop the team to reach for new frontiers of performance and quality.
Roles and Responsibilities
Attend BID Defense meetings, as directed, to provide strategic study start up advice.
Draft CA, EC and contract execution planned monitor the execution of the plan including any revised timelines.
Work with key parties to draft mitigation plans against contractual targets for key breakthroughs.
Responsible for the inclusion of the Study Start Up Plan into the Project Management Plan to be shared and agreed with the sponsor.
Deal with harmonization of processes and procedures during start up across the region and appropriate training of the team members.
In collaboration with the Project Managers identify and present interdependencies to the project team and track key deliverables against responsible parties, driving forward strategies to prevent "Road Block" situations.
Driving the teams' efficiency and adherence to study procedures and timelines; Establishing regulatory requirements and site contracts to ensure a smooth start-up process;
Liaising and coordinating with Project Manager to facilitate consistent communication for start up;
Be the team motivator.
Experience and Qualification
Preferably with a degree in Life Sciences, you will have previous submissions / dossier experience within clinical studies for either a CRO or Pharmaceutical company.
Minimum of 5 Years of experience in a clinical trial lead environment
Good organizational skills and the ability to handle multiple tasks
Meticulous attention to detail
Good written and verbal communication skills. Proficient in English and language required for country assignments
Highly developed analytical skills
Strong people management and effective communication skills
Strong project management skills
Customer service focused
Benefits of Working in ICON :
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
ICON is an equal opportunity employer - M / F / D / V and committed to providing a workplace free of any discrimination or harassment.