Manager, Study Start Up

As a Start Up Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

As a Start Up Manager you will coordinate, manage and facilitate study authorization activities related to preparation, review and approval of country related and site level submissions in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards ; and to ensure that roles, responsibilities and team performance are focused on quality optimization, efficiencies and cost containment.

You will be partnering with a global pharmaceutical company committed to using innovative science to help those with serious and rare diseases. This team prides itself on a family oriented and cohesive environment. If feeling valued and knowing that your voice matters is important to you, this program may be an excellent option.

What you will be doing:

• Review study performance in each country within their remit and as applicable in each region, and 1nst1gate actions to improve performance.
  
• Review study performance for every study led by a Global or Regional Lead from a country within their remit, and instigate actions to improve performance.
  
• Ensure team compliance with ICON systems and procedures.
  
• Ensure that study authorization activities are in alignment with department metrics and goals.
• Where necessary, support the team in study start up related issues within his/her country/region.
  
• Oversee management of submissions (start-up and ongoing) and study start-up activities (as applicable) to ensure they are conducted in an effective manner, meeting sponsor timelines, contractual requirements and expectations; and in adherence with ICON SOPs and appropriate regulations; liaise with other departments as applicable.
  
• Oversee management of studies in regards to department goals set regarding quality, timelines and metrics.
  
• Coordinate and supervise submissions to ECs in collaboration with clinical project: set up project­ specific plan for the submission process and timelines; implement procedures for tracking submission progress; ensure that EC submission packages correspond to the relevant requirements; and coordinate and supervise preparation of country/site specific SIS/ICFs.
  
• Provide financial oversight to ensure appropriate profitability.
  
• Monitor and manage staff workload to optimize resource utilization.
  
• Effectively manage staff through open and timely sharing of information, regular performance review and feedback, and setting of clear goals and objectives.  Ensure individual and team achievements are appropriately recognized.
  
• Provide mentoring and training to staff ensuring that all necessary training is provided according to job title; act as a role model to team members
  
• Continually develop staff to reach their potential through evaluation and monitoring of their development plan.
  
• Continually assess opportunities for process improvements and develop and monitor process change implementation
  
• Provide leadership and effective people management in country/region offices where applicable
  
• Proactively participate in the selection and recruitment of suitable and qualified staff
• Proactively assess , revise, and improve the department training process and requirements to meet changing requirements
• Develop supporting staff skills, encourage growth and provide regular performance feedback
• Assist with training for other departments as department representation, as necessary
• Mentor Study Authorization Managers

You are:

• Bachelor’s degree with a major in a related field and solid experience in study start‐up In‐depth knowledge of start‐up processes and procedures 
• Demonstrates solid understanding of key regulatory authorities and regulatory requirements, ICH Guidelines, and GCP's governing the startup of clinical trials 
• Experience with investigative site start‐up documents
• Good understanding of clinical trial execution
• Fluency in English and in host country language 

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.