Clinical Operations Manager - Cheshire

CK Clinical
£45000 to £55000
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Russell Oakley is currently recruiting for a Clinical Operations Manager for a Clinical Research Consultancy based in Cheshire. The COM reports to the Clinical Operations Director and is responsible for overseeing employees and delegating work tasks within the Clinical Operations team. The person in this position is accountable for the planning and management of all clinical operations activities across multiple clinical projects on behalf of the business. In collaboration with the Clinical Operations Director, they will ensure the consistent delivery of a compliant, efficient and high quality service to the client.

Key Accountabilities/Responsibilities:
* Provide effective and professional leadership, developing, supporting and managing the Clinical Operations team, focusing on both short term development goals (essential knowledge and skills) and the longer term future career development of individuals.
* Support the Clinical Operations Director in planning, defining and implementing the clinical development programme strategy and departmental objectives in alignment with corporate goals.
* Oversee and where necessary take responsibility for the implementation and maintenance of contractual and onboarding processes for clinical operations and the wider business.
* Manage and anticipate the clinical operations demand for assigned clinical programme(s) including oversight of key project deliverables and the management of resources, timelines, budgets, quality, clinical trial sites logistics and vendors.
* Through appropriate cost and time efficient mechanisms take accountability for recruitment of personnel to deliver the company's clinical operations capability.
* Coordinate and input into the activities of all team members involved in the design and conduct of assigned clinical trials, and review and refine clinical operations plans as required.
* Review and approve relevant study documentation.
* Oversee and where necessary contribute to relevant study documentation such as IND submissions, DSURs, BLA submissions, protocols, informed consents, investigator brochures, monitoring plans, and clinical study reports.
* Proactively identify project/clinical trial risks and issues and work with the Clinical Operations Director to resolve these.
* Support the Clinical Operations Director in the management of the full library of documents and overseeing processes to ensure patient risk-benefit is optimized.
* Participate in study data reviews and other review activities as required, driving improved efficiency and effectiveness and embedding learning from previous clinical programmes into the company's processes.
* Oversee the delivery of all study activities in accordance with ICH GCP, health authority regulations, and the company's SOPs.
* Work with the Clinical Operations Director to drive continuous improvement of department infrastructure through review and implementation of new standard operating procedures (SOPs), guidelines/work practices and the use of technology.
* Provide or facilitate training to clinical study teams on assigned protocol specific topics.
* In collaboration with the Clinical Operations Director, monitor and report trial progress and performance, driving constant communication to senior management about the overall clinical operations plan for projects including timelines, internal and external resources/costs, and key deliverables, ensuring alignment to business goals.
* Maintain a positive culture and strong working relationships across organizational functions.

Minimum Requirements - Education and Experience:
* Degree qualified or equivalent in relevant discipline
* Minimum of 10 years' clinical research experience, at least 3 of which are
- Ideally in a recent operational management position in a CRO setting with line management experience
* Detailed understanding of ICH GCP guidelines
* Proven track record showing clear proficiency in clinical project management skills
* Solid vendor management skills, e.g. CRO, Laboratory & Clinical supply logistics
* Broad understanding of clinical operations related to clinical development functions
* Detailed understanding of all aspects of clinical protocol design and implementation and overall drug development
* Ability to effectively interface with medical personnel at clinical sites
* Ability to lead multi-disciplinary, cross-functional teams both internally and externally

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.