Convergence Pharmaceuticals  -  Global Clinical Project Manager

Convergence Pharmaceuticals is an independent biotechnology company focused on the development of novel, high value analgesics for the treatment of chronic pain. Our pipeline of differentiated clinical-stage compounds targets the points of convergence in chronic pain signalling through modulation of specific ion-channels.

Role Overview:


As we expand our clinical trials into Phase III, we are seeking to recruit an experienced Global Clinical Project Manager to join our Clinical Operations team, reporting to the Head of Clinical Operations. You will be responsible for managing the Phase III clinical trials including long-term safety studies, initially supporting an indication in Trigeminal Neuralgia. As Convergence operates an outsourced model you will have responsibility for selecting and managing full-service CROs. This post would suit an experienced senior Clinical Research Associate (CRA) or Clinical Project Lead looking for a new challenge. 


Location:  

Babraham Research Campus, Cambridge, however consideration will be given to home/field based location within UK

Key Job Responsibilities

  • Accountable for the delivery of Phase III & Phase IV programs.
  • Manage study budgets.

  • Responsible for evaluation and selection of CROs.

  • Accountable for ongoing management of all outsourced services directly supporting Phase III and IV clinical studies, including but not limited to Clinical Operations, Pharmacovigilance and Regulatory functions.

  • Review of study documents including protocols, informed consent, monitoring reports and study plans.

  • Attendance at investigator meetings and co-monitoring visits for managed studies.

  • Coordinate external consultant input into full-service outsourcing as required, for example, data management and statistical consultants.

  • Responsible for the set up and delivery of the clinical supplies strategy to support phase III and Phase IV clinical studies.

  • Participation in the development project team and quality meetings.

Candidate Requirements

  • Significant Pharmaceutical research and development experience in Clinical Operations including managing Phase III studies.
  • Demonstrated expertise in managing clinical outsourcing ideally managing full-service outsourcing and in the identification, evaluation and selection of CROs.

  • Strong leadership skills.

  • Good communication and presentation skills.

  • Excellent influencing and negotiation skills.

  • Experience of managing clinical studies in US and Europe.

Salary: 

Competitive

Benefits: 

Pension, Life Assurance, Income Protection, Private Healthcare, Share Options, 30 days holiday and free on-site parking.

To apply: If you are interested in applying please send your CV to: recruitment@convergencepharma.com

Closing date:  10 October 2014

No agencies - thank you