Hobson Prior are seeking a Clinical Trial Supply Manager to join a leading biotechnology company who specialise in delivering biological therapies to enable patients living with serious diseases to live a better life.
- Define and implement labelling, packaging and supply strategies that not only meet the requirements of the study design, the clinical study sites and the relevant regulatory authorities, but also maximise efficiency of supply.
- Manage the generation and approval of label text, certified translations and label proofs.
- Accountable to manage the generation, approval, distribution and implementation of clinical randomisation schedules making sure the process is fully documented and relevant blinding is maintained.
- In co-operation with the Clinical teams, establish the specifications of any required IRT systems, conduct UAT and monitor functioning of the IRT systems throughout the trials.
- Represent as the first point of contact and manage relationships with IRT, packaging, labelling and distribution vendors.
- Manage labelling, packaging and distribution activities including review and approval of labelling/ packaging records and distribution plans.
- Manage the procurement and distribution of rescue medications and ancillary materials ensuring that all study specific regulatory requirements are met.
- Manage and review IMP and ancillary inventory levels at manufacturing facilities, distribution hubs and local depots to ensure supplies are adequate according to the demand.
- Take charge of activities relating to the accountability, reconciliation, return and destruction of study supplies.
- Create pharmacy manuals to support use of the IMP at clinical sites.
- Excellent attention to detail.
- Strong interpersonal skills.
- Masters, Bachelors or equivalent degree in Pharmacy or relevant scientific discipline.
- Previous experience in the provision and management of clinical trials supplies and associated activities.
- Experience of design, implementation and management of IRT systems for multi-regional studies.
- Experience of managing external CROs.
- In-depth understanding of GxPs and the global regulatory requirements relating to the labelling and supply of clinical supplies.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.