Global Study Start-Up and Regulatory (Clinical Operations) Project Manager
Office based in Central London
An exciting opportunity to join a rapidly growing CRO with a strong industry reputation for quality is seeking a Global Study Start-Up and Regulatory Project Manager to join the business on a permanent basis, with the chance to join a growing department and potentially take on some line management responsibilities in addition to core project management activities.
- Effectively direct and coordinate all aspects of global study start-up activities according to sponsor and project specifications.
- Perform quality checks on submission documents and essential site documentation.
- Lead a team of Study Start-Up Coordinators to ensure necessary approvals in place across different regions globally.
- Prepare and approve informed consent forms.
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges.
- Present during bid defences, audits and capabilities meetings.
- Key point of contact for the sponsor regarding study start-up activities.
- Potentially carry out line management activities for locally based Submissions Coordinators.
- Previous experience of coordinating study start-up activities and regulatory submissions internationally (at least across European countries).
- Previous hands-on experience of conducting ethics and local health authority submissions.
- A minimum of a Bachelor's degree in a life science.
- Must have prior experience in a similar position within a CRO, Biotech or Pharmaceutical Company.
This position represents a great opportunity to join a growing organisation with a strong industry reputation and low staff turnover, with good prospects for career development due to this being an expanding team.
If you are interested in exploring such a career move please forward your CV to Sam.Doherty@secpharma.com or call +44 (0) 207 255 6665 and ask for Sam Doherty.