Senior Manager, Study Start Up

hace 5 meses

Madrid, España ICON plc A tiempo completo

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

**ICON is looking to hire a Senior Manager to lead their Global Regulatory and Start-Up team.**

Role is flexible to be home based anywhere in UK, Ireland, Poland, Spain, Italy.

This is an exciting opportunity to work with ICON’s senior leadership to oversee the global end to end activities of the SSU department for Real World Evidence and Medical Device.

As **Senior Study Start Up Manager**, you to be involved in the overall department strategy & mentorship of group leads, Site Activation Leads and Sites Start Up Specialist to ensure timely end to end site activation.

**The Role**:

- Manage a team of RWE & MDDR Regulatory Specialists and Start-up and Operations Support Associates (+ 15 direct reports)
- Responsible for oversight of hiring, coaching, and promoting staff and for projecting and allocating appropriate resources within the department
- Participate in company business development activities (proposals, budgets), in QA activities (SOPs, internal or external audits, subcontractors audits.) and new strategies development
- Supervise the development and execution of submission strategies for ROW countries Oversight of studies start-up phase
- Supervise the maintenance and update of our internal Regulatory Database to capitalize experience and maintain knowledge of RWE regulatory requirements and guidelines across all regions
- Provide ongoing support and advice to internal and external (sponsors) team for Regulatory, may also provide support and advice for contracts management.

**To be successful in this role you'll need**:

- 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 Study Start Up.
- Strong mentoring, line management and team leadership skills - in order to lead a team group leads, overseeing the global start up team
- You will possess significant experience in working 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.
- You will also have excellent interpersonal skills given that your role will have you chairing significant negotiation discussion with both internal and partners and sponsors.
- Experience in RFP /Bid defense, optimizing the best regulatory strategy for optimal site activation.

**Benefits of Working in ICON**:
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.

At 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.

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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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