Global Study Lead
- Experience Level
- Senior Management
Hobson Prior are looking for two Senior Clinical Study Managers to join a clinical-stage biotechnology organisation in Cambridge, who are focused on unmet medical needs with a pioneering pipeline. This is an excellent opportunity to become part of the team and experience first-hand working in the Biotech industry.
Please note that to be considered for this role you must have the right to work in this location and you must have previous experience working within clinical research within the UK, as a Clinical study manager, clinical trial manager or clinical project manager within the Pharmaceutical industry.
- Set-up and manage the organisations Phase 1-3 sponsored studies, ensuring they are conducted to appropriate corporate and regulatory standards, including oversight of clinical conduct, drug supply, regulatory submissions, data management and statistical activities to clinical study report finalization.
- Works with the wider clinical team, including scientists and medics, to develop the study design and may input into overall clinical development plan.
- Accountable for management of clinical study budgets and timelines, and for ensuring that forecasted budgets and schedules are met.
- Accountable for oversight and management of Clinical Service Providers, CROs and external consultants.
- Responsible for authoring, contributing and review of study documents including protocols, amendments, regulatory documents, informed consent, monitoring reports and study plans.
- Accountable for ensuring that the eTMF is maintained in accordance with the TMF plan.
- Partaking at investigator meetings and co-monitoring of clinical studies.
- Robust communication and influencing skills.
- Self-motivated and able to work self-sufficiently.
- You will have a bachelor's degree or equivalent in a relevant field preferably Biological / Life Sciences, or equivalent experience.
- Significant demonstrable Clinical Development/Operations experience gained within the pharmaceutical industry.
- Previous experience in managing multiple projects and priorities.
- Previous experience managing internal and external resources.
- Early/mid phase drug development experience.
- Strong working knowledge of GCP/ICH guidelines.
- Knowledge of other related drug development functions.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.