Clinical Operational Lead

Reporting to the Head of Clinical Operations you will be an integral member of the EMS Healthcare Clinical Operations Team.

You will assist the Head of Clinical Operations in the oversight of all clinical research projects, and lead on the management of clinical operations activity including staffing, delivery and managing the team of regional staff who will provide clinical oversight to the community research unit teams.

You will be responsible for ensuring that clinical operations run smoothly to facilitate delivery to time and target across the portfolio.

You will ensure that sites are delivering clinical research at a high quality and within a safe clinical research environment, manage clinical operations including nursing and research practitioner activities related to clinical trials, from initiation to close out according to ICH-GCP guidelines and regulatory requirements. This includes the safe, quality and patient-centred care of all of the research participants. You will also ensure commercial success through the successful recruitment and delivery of clinical trials by providing professional leadership to all direct reports and being responsible for the training, professional development, and supervision of your team. Be involved in developing systems and processes, and maintain an agile, competent, flexible research delivery team.

You will develop excellent relationships across the different divisions within the organisation as well as all client contacts. You will be involved in reviewing and assessing the feasibility of pipeline studies and from that building on the wider client contact base.

**Requirements**:
**Qualifications**
- NMC Registered Nurse - Essential
- A scientific degree, post graduate qualification or equivalent.
- Good Clinical Practice Training
- Good working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical trials research.

**Experience**
- Substantial Experience as a Senior Clinical Research Lead with a minimum of 5 years working in a clinical research setting
- Strong leadership skills and a proven history of leading teams. Experience of staff management and development, clinical supervision and monitoring.
- Experience of delegating responsibilities and prioritising workload
- Wide ranging experience in the conduct of clinical trials, including commercial trials.
- Experience of working on clinical trials involving ‘Clinical Trials of Investigational Products (CTIMPs).
- Ability to monitor the quality of own and others work
- Experience of audits and regulatory inspections.
- Experience of developing and implementing policies and procedures
- Ability to deal with conflict situations and experience of handling clinical incidents and complaints.
- Understanding and rising to the challenges in research delivery (including non-traditional research settings)
- Experience in Clinical Procurement and Vendor
- Excellent IT skills and proficient in using Microsoft Office.
- Excellent communication and presentation skills
- Ability to establish/maintain good relationships with sites/colleagues/clients
- Ability to make decisions independently / Strong problem-solving skills
- Self-motivation to research and understand the healthcare sector and NHS markets.
- A flexible approach to work

**Other Requirements**
- Full UK residency and hold a valid driving license and have suitable transport provisions (public transport is not recommended due to location of offices).
- Able to travel throughout the UK and Overseas if required.

**Benefits**
- 25 days holiday increasing to 28 after 5 years’ service
- 1 Occasion day each year, _this could be your child’s first day at school, their nativity play or your own birthday - the choice is yours_
- Flexible hours and days negotiable (up-to FTE 39.5 hours per week)
- Opportunity to buy up-to 10 days additional annual leave
- Opportunity to sell up-to 5 days annual leave
- Enhanced maternity and paternity leave
- Healthcare Cash Plan scheme
- Long service awards
- Discounts and savings platform
- Cycle to work scheme
- Car salary sacrifice scheme