Overview
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 supervising the team of regional staff who 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 sites deliver 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 research participants. You will also ensure commercial success through the recruitment and delivery of clinical trials by providing professional leadership to all direct reports and being responsible for training, professional development, and supervision of your team. You will be involved in developing systems and processes, and maintaining an agile, competent, flexible research delivery team. You will develop excellent relationships across the organisation and with client contacts, review and assess the feasibility of pipeline studies and build on the wider client contact base.
Responsibilities
* Lead on the management of clinical operations activity, including staffing, delivery, and overseeing regional staff who provide clinical oversight to community research unit teams.
* Ensure that clinical operations run smoothly to deliver projects on time and to target across the portfolio.
* Maintain high quality clinical research delivery in a safe environment and ensure compliance with ICH-GCP guidelines and regulatory requirements.
* Oversee nursing and research practitioner activities related to clinical trials from initiation to close out.
* Provide professional leadership to direct reports, including training, professional development, and supervision of the team.
* Develop systems and processes to support agile and effective research delivery.
* Build and maintain relationships across divisions and with client contacts; assess feasibility of pipeline studies.
Qualifications
* NMC Registered Nurse – Essential
* A scientific degree, postgraduate qualification, or equivalent
* Good Clinical Practice Training
* Strong working knowledge of clinical trial regulations, GCP guidelines, and related frameworks and their implications for clinical trials
Experience
* Substantial experience as a Senior Clinical Research Lead with a minimum of 5 years in a clinical research setting
* Strong leadership skills with proven experience in staff management, 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 in 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 developing and implementing policies and procedures
* Ability to handle conflict situations and clinical incidents and complaints
* Understanding of challenges in research delivery, including non-traditional settings
* Experience in Clinical Procurement and Vendor management
* Excellent IT skills with proficiency in Microsoft Office
* Excellent communication and presentation skills
* Ability to establish and maintain relationships with sites, colleagues, and clients
* Decisive, independent problem-solving skills; self-motivated to learn about the healthcare sector and NHS markets
* Flexible approach to work
Other Requirements
* Full UK residency and hold a valid driving license with suitable transport provisions
* Able to travel throughout the UK and overseas if required
Benefits
* 25 days holiday increasing to 28 after 5 years of service
* One occasion day each year (e.g., child’s first day at school, nativity play, or your birthday)
* Flexible hours and days negotiable (up to 39.5 hours per week)
* Opportunity to buy up to 10 additional days of annual leave
* Opportunity to sell up to 5 days of annual leave
* Enhanced maternity and paternity leave
* Healthcare Cash Plan
* Long service awards
* Discounts and savings platform
* Cycle to work scheme
* Car salary sacrifice scheme
If you want to join us as our Clinical Operations Lead, click apply now!
#J-18808-Ljbffr