Senior Clinical Operations Manager

Hobson Prior are looking for a Senior Clinical Operations Manager to join a leading pharmaceutical organisation in London to take a leadership role in managing the internal/external study team members and ensure that the timeline, budget, quality and integrity of clinical trials is consistent with the clinical study protocols and other study requirements.

Job Responsibilities:

• Represent as the primary contact for all study operational management related communications with Service Providers/Contractors and the organisation's Development HQ.
• Be accountable for setting up, implementation and reporting of clinical trials working with the project team and external Service Providers/Contractors.
• 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.
• Act as the point of contact for managing/answering questions related to trial procedures and patients' eligibility.
• Managing SPs/Contractors and overseeing their performances and quality of work to ensure they meet the project plan, contracts and any study specific requirements.
• Take a leadership role for the selection of SPs/Contractors.
• Establish scope of works, budget, timeline and the organisation's expectation for SPs/Contractors, develop and maintain contracts with SPs/Contractors.
• Monitor assess and report on their performance and quality of work (especially to ensure that CRAs are monitoring the study as expected).
• Managing and overseeing the internal study team to meet the project plan.
• Any other assigned tasks.

Key Skills:

• Good negotiation skills.
• Strong written and spoken English.
• Excellent communication skills (verbal and written), organisation, presentation and time management skills.
• Proficient computer skills in Word, Excel, PowerPoint, email and Internet.
• Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
• Ability to oversee and manage CROs throughout the entire clinical operations life cycle of a study.

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, pharmaceutical, or Biotechnology Company.
• 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.
• In-depth knowledge of regulatory requirements, clinical development, and clinical monitoring procedures.
• Demonstrated proficiency with ICH/GCP guidelines.
• Experience working in a team environment under time and resource pressures.

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.