Hobson Prior are seeking an experienced Senior Programme Manager to join a small biotech company based in Oxford that are currently engaged in multiple clinical trials to produce research into oncology and the treatments of infectious diseases.
- Manage development programmes whilst adhering to internal SOPs, ICH GCP, relevant guidelines and all applicable laws and regulations.
- Co-operate with cross-functional teams to effectively manage assigned clinical programmes to ensure agreed programme deliverables are met to the appropriate standards of quality.
- Prepare and produce study and programme documentation and reviewing further documents e.g. protocols, IBs, IMPDs, DSURs, ICFs, CSRs.
- Maintain clinical trials inventory in collaboration with third party storage & distribution specialists.
- Manage study budgets, for both forecasting and financial management of studies.
- Prepare IRB/IEC and other required study submissions and provide essential documents for regulatory review and submission.
- Maintain documentation of programme and associated study activities, decisions, actions and risk assessments.
- Selection and oversight of assigned CROs, vendors or contract monitors (CRAs), as appropriate.
- Coordination of IRB/IEC and other required study submissions, and provision of essential documents for regulatory review and submission.
- Accountable for Sponsor Oversight File and/or TMF creation, maintenance and review by Clinical Trial Administrator, to ensure ‘inspection- readiness’ of documentation at all times.
- Support departmental development work
- Shows personal drive and goal orientation.
- Enthusiastic and able adjust well to change.
- Strong organisational and prioritisation skills to manage a various workload.
- Capable of interacting with individuals at all levels of the organisation.
- Able to manage multiple priorities.
- Ability to work in a dynamic small team environment
- BSc or equivalent
- Strong clinical programme management experience of at least 5 years within a pharmaceutical, biotech or CRO company.
- Experience in overseeing external vendors (CROs, central labs, imaging vendors, etc.)
- Strong knowledge of GCP and current legislation.
- Accurate knowledge of the clinical development process.
- Ability to travel in the UK and abroad if needed.
- Experience in virology and/or Infectious Disease studies
- Previous experience of working with GMO.
- CRA/monitoring experience.
- Experience of EDC and eTMF; comfortable with electronic systems e.g. CTMS.
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.