Senior Clinical Operations Manager

We are working with a small-sized Pharmaceutical company who focus within 3 main Therapeutic Areas Oncology, Immuno-Oncology and Neurology. Our client is looking for a Clinical Operations Manager to join them on a contract basis where you will be based in London.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Conduct oneself at all times in accordance with the working practices and ICH GCP.
• Leadership of the cross functional Study Team, including Ono functions, Strategic Partners and other vendors, to provide study management and oversight, ensuring study objectives are met, on time and within budget.
• Manage clinical study/studies according to global regulatory requirements and Ono SOPs, and supporting clinical strategy defined in Clinical Study Plan.
• Be the primary contact for all study operational management related communications with Service Providers /Contractors and Ono Development HQ.
• Responsible for providing study level updates, including Risks, timelines, & budget to the HCO ensuring that any study issues, with proposed solutions, are escalated as appropriate.
• Establishing, monitoring and managing the study timeline and study budget.
• Monitoring and reporting the study progress and quality, analysing potential issues and risks, and escalating / resolving them as appropriate.
• Ensuring appropriate recruitment strategy and plans are in place and adhered to.
• Point of contact for managing/answering questions related to trial procedures and patients' eligibility.
• Take a leadership role for the selection of SPs/Contractors.
• Establish scope of works, budget, timeline and the expectations for SPs/Contractors, develop and maintain contracts with SPs/Contractors.
• Monitor, assess and report on their performance and quality of work.
• Managing and overseeing the internal study team to meet the project plan.
• Author/review and/or authorize all appropriate study documents.
• Provide input to study documents, including e.g., but not limited to, study protocol, statistical analysis plan, clinical study report, audit plan, and/or author relevant sections of study documents.
• Organizing and chairing the monthly project meeting.
• Organizing study meetings / training as required.
• As an overseeing role, supervising, mentoring and assisting COM, when required, to ensure adherence to agreed project plan, budget, and quality specifications for individual clinical trial.
• Taking a leading role and contributing to development and maintenance of company policies, SOPs and documents.
• Ensuring learning and knowledge transfer during and at the completion of the clinical trial.
• Contributes to process improvement to support evolving quality systems for global study management and operations.

Requirements:

• Minimum BSc in the life sciences, nursing degree, or equivalent combination of education and experience.
• Significant demonstrable clinical research experience gained within a contract research organisation (CRO), pharmaceutical, or Biotechnology Company, with proven experience of technical and/or project management in conducting multi-national and/or single site early phase clinical trials in a pharmaceutical company or CRO.
• Thorough knowledge of global regulatory and local country requirements including but not limited to US CFR, EU CTD, and ICH GCP, clinical development, and clinical monitoring procedures.
• Demonstrated excellence in study management, including innovative operations approaches ro achieving program goals.
• People management experience; Matrix management, and/or direct.
• Demonstrable experience of leading project/study teams.
• Ability to oversee and manage CROs throughout the entire clinical operations life cycle of a study.

Apply now:

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.