Clinical Project Manager - US
Hobson Prior are currently working with a clinical-stage biotech organisation whose passion is to work together as one team and noticeably making life changing impact. Our client is seeking a Clinical Project Manager for an exciting permanent position based in the US.
- Accountable to lead the planning and execution of clinical studies from Phase I to IV in adherence to Good Clinical Practice, Standard Operating Procedures, Food and Drug Administration regulations, EU Directives & Guidance, and International Conference on Harmonisation guidelines.
- Lead site selection and site qualification discussions with project team and CRO.
- To ensure the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed by the Project Team.
- Lead document writing and review for the protocol and amendments, Investigator brochure and Clinical Study Report. Additional medical writing tasks may involve ICF, CRF and associated guidelines, safety communications, DSUR and additional key documents.
- Lead the study team meetings.
- Lead the creation of the Trial Oversight Plan and ensure adherence. CRO and Quality Oversight
- Ensure CRO selection is appropriate for the study planned.
- Validate the study plans provided by the CRO through to study close out.
- Accountable for management of CRO performance to ensure adherence to scope of work within timelines and budget at an overall study level.
- Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study.
- Recognise issues early and propose solutions.
- Any other assigned duties.
- Robust oral and written communication skills.
- Highly organised and able to plan, prioritise and manage time efficiently.
- Collaborative working style with ability to partner across the organisation.
- Self-motivated and able to work self-sufficiently.
- Degree in a relevant discipline.
- At least 5+ years' experience within the pharmaceutical industry in clinical operations, including project management experience, ideally at national and international level.
- Strong experience of vendor management and oversight of clinical studies and study teams across all phases of development including.
- Familiarity with a broad spectrum of clinical operations concepts, practices, and procedures with an understanding of the process and regulations that apply to clinical investigations including knowledge of EMA/FDA regulatory requirements and ICH GCP guidelines.
- Strong scientific, operational, and regulatory expertise.
- Demonstrates knowledge of design and operational management of clinical studies globally, including regulatory requirements, CRO capabilities and compliance practices.
- Ability to communicate effectively, including with therapy area experts and patient advocacy groups.
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.
£60000 - £70000 per annum + bonus
Hobson Prior are currently working with a clinical-stage biotech organisation whose passion is to work together as one team and noticeably making life changing impact.
Hobson Prior are looking for a Senior CPM for an exciting opportunity to take your career to the next level and lead challenging full-service global clinical research projects.
$125000 - $130000 per annum
We are recruiting for a Senior CPM to join a leading human data science organisation on a remote basis. Our client are focused on helping healthcare clients
€125000 - €130000 per annum
Hobson Prior are in search for a Head of Clinical Operations DACH who will join a biopharmaceutical organisation who are determined to discover and deliver pioneering medicines
CHF50 - CHF60 per hour
Hobson Prior are in search for a Project and Office Coordinator for Order Management Languages to join an international healthcare organisation who are focused on offering medical solutions
£60000 - £75000 per annum + Benefits
Hobson Prior are looking for a Senior Clinical Project Manager to join a world-wide leading ophthalmic research organisation on a permanent basis in London with lots of home-working
Hobson Prior are currently looking for a Clinical Project Manager to join a leading CRO who has over 40 years of global experience, with a global team dedicated to bringing ophthalmic
£55000 - £60000 per annum
Hobson Prior is currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses.
CHF130000 - CHF140000 per annum
Hobson Prior are looking for an Clinical Study Manager to join a drug discovery and development company who concentrates on developing antibody-based drugs
£70000 - £75000 per annum
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