Hobson Prior are looking for a Clinical Study Manager to join a leading biotech organisation who are Gene Therapy focused and are looking for an individual to be Home-based (UK or France) and will travel to their London office a few times per month.
- Play an essential role in the Clinical Operations team leading clinical studies within a single programme.
- Represent as an expert in your therapy area, working independently with guidance in only the most complex situations.
- Assist as a close partner to the study physicians, co-ordinating the activity of a research team and holding full accountability for projects, often with global impact.
- Hold key relationships with internal stakeholders within the clinical project team, as well as externally with KOLs, investigators and external service providers.
- Lead the development and design of studies to determine the scientific viability of a particular cell product and interpret the results of these studies, either as the head of a team, or by providing expert input.
- Lead the protocol writing and strategy in conjunction with other key members of the project team.
- Review and interpret medical data and clinical trial data, draw conclusions and potentially identify new research and development opportunities.
- Create/Review patient consent forms and provide relevant opinion.
- Accountability for the delivery of components of clinical trials.
- Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers.
- Thorough knowledge of ICH-GCP guidelines and FDA regulations.
- Ability to manage multiple projects.
- Excellent communication, interpersonal and organisational skills.
- Effective problem-solving skills.
- Attention to detail and timelines.
- Strong clinical study experience in Oncology coupled with pharma/biotech Industry experience.
- Strong clinical, technical or disease area expertise.
- Knowledge of medical terminology and clinical patient management.
- A minimum of 3-5 years’ experience of working as a Clinical Project Manager.
- Previous experience of site monitoring in oncology studies.
- Previous experience in oncology early phase studies.
- Previous experience with ATIMPs an advantage.
- Bachelor’s degree (BSc, BA or RN equivalent) in biological or science-related field is essential.
- Preferably an advanced degree (i.e. PhD, MSc) in a relevant scientific discipline or related experience.
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.