Study Start Up Manager

Study Start Up Manager

Flexible on location throughout EU

This is an exciting opportunity to work within a fast paced, world class CRO in a dedicated, passionate team operating within a collaborative work culture where accountability and integrity are at the heart of our organization.

As Study Start Up Manager, you will manage a global team of Study Start Up Associates across EMEA,  Americas and APAC (size of team  20 FTE) within our Centralized Patient Consent Team.   The core purpose of this role is to coordinate, manage and facilitate the activities related to preparation, review and approval of Study Master, country related and site level Informed Consent documents in accordance with internal / external SOPs as applicable eg ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards; and to ensure that study authorization roles and responsibilities are focused on quality optimization, efficiencies and cost containment.

Role Responsibilities:  

• To mentor and lead a team of 20 Study Start Up Associates globally, working with and through others.
• Lead and drive creation, review, and approval of Informed Consent Forms / related documentation
• Create and negotiate processes with Sponsors, Portfolio Directors, and other stakeholders as applicable
• Deliver training to members of the team as well as global study teams to ensure quality and alignment of processes
• Continually assess opportunities for process improvements and develop and monitor process change implementation.
• Provide financial oversight to ensure appropriate profitability and Monitor and manage staff workload to optimize resource utilization. 

Your background and experience:

You will likely have a blend of the following skills. 

Educated with a degree in Life Sciences and In depth proven clinical research industry experience.  You will have had a career to date which will have included clinical trials allowing you to have an In-depth knowledge of the Informed Consent procedure (preparation, review and approval) from a regulatory perspective.  You will also have significant experience in the preparation, review and approval of Study Master, country related and site level Informed Consent documents in accordance with int./ext. SOPs as applicable, ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards.  In a highly regulated environment and tight timelines to open study sites you should have effective prioritization skills and ability to multi-task with meticulous attention to detail. Given that this role will lead a global team of cc 18 – 20 individuals, you will have strong mentoring skills, team management and team leadership.  You will also have excellent communication skills given that your role will have you chairing significant negotiation discussion with both internal stakeholders, external partners and sponsors.

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, life assurance and staff recognition schemes. 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.

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