Hobson Prior are currently recruiting for a Senior Clinical Operations Manager to join a globally competitive pharmaceutical company whose focus is to develop pharmaceuticals that are beneficial in keeping people healthy in their daily lives.
- Conduct oneself at all times in accordance with the organisations working practices and ICH GCP.
- Accountable for setting up, implementation and reporting of clinical trials working with the project team and external Service Providers/Contractors.
- Represent as the primary contact for all study operational management related communications with Service Providers /Contractors and the Development HQ.
- 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.
- 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 organisations expectation for SPs/Contractors, develop and maintain contracts with SPs/Contractors.
- Monitor assess and report on their performance and quality of work (specially to ensure that CRAs are monitoring the study as expected).
- Managing and overseeing the internal study team to meet the project plan.
- Developing and maintaining study documents with internal and external project teams.
- Author/review and/or authorise all appropriate (operational) study documents.
- Deliver 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.
- Excellent communication skills (verbal and written), organisation, presentation and time management skills.
- Diplomatic and tactful in liaising with staff and management.
- Ability to review both data and procedures in detail and the ability to see the greater overall picture.
- Capable 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.
- Able to interact effectively at all levels within the organisation, as well as with external partners and clients.
- 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.
- In-depth knowledge of regulatory requirements, clinical development, and clinical monitoring procedures.
- Proficient with ICH/GCP guidelines.
- Proficient computer skills in Word, Excel, PowerPoint, email and Internet.
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.