Clinical Project Manager

Hobson Prior are looking for a Clinical Project Manager to join a leading biotech organisation on a contract basis. This role is to be Home-based in the US.

Job Responsibilities:

• 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.
• You will 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 site selection and site qualification discussions with project team and CRO.
• Ensure CRO selection is appropriate for the study planned.
• Validate the study plans provided by the CRO through to study close out.
• Co-operates with other key functions to maintain audit and inspection readiness.
• Contributes towards development and implementation of process to ensure clinical studies are managed within a robust regulatory and operational framework.
• Engage and build relationships with clinical sites in North America (and potentially South America).

Key Skills:

• Highly organised and able to plan, prioritise and manage time efficiently.
• Strong oral and written communication skills.
• Collaborative working style with ability to partner across the organisation.
• Self-motivated and able to work independently.
• Ability to communicate effectively, including with therapy area experts and patient advocacy groups.

Requirements:

• Degree in a relevant discipline.
• A minimum of 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.

Apply now:

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.