Operations Manager (Delivery)

Job description

We are looking for an exceptional candidate to join the CPTU as an operations manager.  You will be responsible for operations management across the CPTU portfolio of trials with a focus on early project support, trial team recruitment, resource planning and post-award grants management. You will ensure projects are set-up according to agreed milestones and in accordance with applicable legislations and procedures, including the CPTU or sponsor quality management system (QMS).  Our portfolio of projects comprises complex interventions e.g. unusual trial designs, non-standard delivery approaches or implementation research and therefore requires an individual with expertise in complex clinical research delivery and project management.

You will have a strong interest in clinical research operations, research design and development, research governance, and experience of fostering strategic relationships with a range of stakeholders. You will be an effective communicator who is adaptive to their audience, with an intrinsic interest in improving the health and well-being of communities through translational research and evidence-based innovation.

You will line manage a team including both trial specific and core CTU staff.  You will report to and be supervised by Dr Michelle Sleeth, Head of Operations of CPTU.  Your seniority will offer the potential to coach and line manage other staff.  You will be required to develop strong working relationships with other operations managers and senior trial management staff across King’s.

We value your professional growth and you will have opportunities to attend conferences and training.

This post will be offered on an a fixed-term contract for 12 months

This is a full-time  post

This post is subject to Disclosure and Barring Service

Key responsibilities

You will: 

• Oversee and provide early project support for new trials on the CPTU portfolio, including facilitating research collaborations and contracting
• Be the senior CPTU team member responsible for the effective scoping and planning of newly funded projects and ensuring they progress through unit portfolio adoption processes
• Lead the recruitment of trial specific teams, resource planning and service utilisation (trial management, databases, statistics, data management), providing a robust handover and training plan once teams are in place
• Initiate protocol development with investigators in accordance to applicable legislation and procedures
• Manage grants post-award for trials on the CPTU portfolio, especially for multi-institutional projects
• Actively contribute to the research planning and management in partnership with the chief investigator(s), sponsor, clinicians, executive and steering groups and study teams
• Prepare concise, informative and professional projects reports for project stakeholders to effectively communicate project progress
• Set overall standards for trial management by overseeing and approving the writing and distribution of written trial procedures where appropriate
• Provide support to trial teams, and develop new initiatives to ensure they are working to the highest standards
• Ensure appropriate contractual arrangements are in place and documents held on file
• Use expertise and knowledge of complex project management during planning stages to identify potential risks and oversee the implementation of risk mitigation strategies
• Responsible for line management of core trials unit staff (including work allocation and monitoring performance and time keeping)
• Maintain knowledge and be responsible for advising others in the conduct of clinical research, particularly in trial set-up activities
• Make a direct input into the strategic and operational objectives of the CPTU and its relationship with the wider research community
• Advise on management resource needs in response to the changing status of the protocols and their deadlines
• Utilise analytical skills to understand complex and at times, fragmented information, and independently propose solutions where there is variation in expert opinion or information not available
• Deputise for the CPTU Head of Operations in their absence      

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.  

Skills, knowledge, and experience 

Essential criteria  

1. Degree in any life science or numerate discipline, or a professional qualification (e.g. nurse) or equivalent experience in a similar role             
2. Experience in overseeing all areas of complex clinical research project management including project set-up, data and pre-and post-award grants management 
3. Strong delegation skills and ability to develop and implement robust procedures to support individuals within the full capacity of their role 
4. Experience in line management of multidisciplinary teams/staff and managing varied workloads and resource allocations 
5. Expert knowledge in current regulations governing the conduct of clinical research including Good Clinical Practice, the UK Policy Framework for Health and Social Care Research, Health and Social Care (National Data Guardian) Act 2018, Medicines for Human Use (Clinical Trials) Regulations Statutory Instrument 2004, Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, and The Human Tissue Act 2004 and the Declaration of Helsinki and any other applicable regulations 
6. Understanding of NHS strategic goals, research structure and organisation 
7. Ability to produce appropriate reports and trial management written procedures and show attention to detail and high standards of accuracy in all aspects of work           
8. Experience of explaining complex ideas in an appropriate format for academic and non-academic groups  
9. Experience of working independently, making independent decisions, and working to and meeting firm deadlines 
10. Excellent verbal and written communication skills, particularly in the context of scientific writing, reports and good telephone manner e.g. ability to persuade and deliver information effectively through presentations 

Desirable criteria

1. Experience of financial planning and implementation, including preparing budgets, preparing business cases, and monitoring key performance indicators, budgets (including reconciliations) and risks 
2. Experience of primary care research and working with academic and commercial sponsors 
3. Formal qualification in clinical trials (or working towards one) or post graduate qualification in clinical trials or relevant field 
4. Knowledge of electronic data capture systems for clinical trials