Senior Study Start-Up Manager - London

This role will see you dealing with projects in pioneering Advanced Therapy IMPs within the rare disease/gene therapy space and give you the opportunity to gain experience in complex trials. You will be able to enjoy training programmes which have been recognised as one of the best within the industry; opportunities to enhance and diversify your skills to follow a clearly defined career progression path.


Responsibilities:

  • Efficiently managing and successfully executing all aspects of global start-up;
  • Performing quality checks on submission documents and site essential documents;
  • Preparing and approving informed consent forms;
  • Reviewing pertinent regulations to develop proactive solutions to start-up issues and challenges;
  • Presenting during bid defenses, general capabilities meetings, and audits
  • Leading a country/regional Regulatory Submissions team.

Requirements:

  • You must have previous experience in regional/global management of study start-up / submissions
  • In-depth knowledge of start-up and maintenance processes and procedures in the EU (experience in other regions will be also appreciated)
  • Bachelor's degree in a related field
  • Excellent project management skills
  • Excellent collaboration and team work skills
  • Previous experience in managing a regulatory submissions team, for the line manager positions.

 

 This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be.

 

To make an application please feel free to apply via this website, I am also available on LinkedIn to message regarding the role and will accept all invitations that refer to this advert - look for Dominic Mitchell at RBW Consulting.

 

Please note that owing to the high volume of applications we receive for our roles, if you have not received a response within 48 working hours, do please consider your application unsuccessful.

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