Clinical Research Sponsorship Lead

University Hospital Southampton NHS FT; Southampton; On-site; GBP 55,000 - 75,000; Full time

Benefits offered by this job

NHS discounts

35 days paid holiday pro rata

Generous pension scheme

Job summary

University Hospital Southampton NHS Foundation Trust invites applications for a Sponsorship Portfolio Manager within the Research & Development Department. The role oversees sponsor oversight for Trust-sponsored studies and ensures compliance with legislation and guidance.

The position involves developing oversight processes, advising researchers, and coordinating with grants, contracts, CROs and CTU. On-site work is required at least two days per week with flexible options where service needs

Qualifications

• Educated to degree level or equivalent knowledge in research.
• Experience in medical research methodology and clinical trial regulations (GCP).
• Evidence of continuing professional development (CPD).
• Experience with NHS or commercial health research settings.
• Familiarity with research governance and quality assurance systems.
• Training in monitoring of clinical research studies.

Responsibilities

• Develop and implement sponsor oversight processes for all Trust sponsored studies.
• Provide assurance that researchers and staff comply with governance and regulatory requirements.
• Review study protocols for regulatory compliance and monitor adherence to UK clinical trial regulations.
• Create and oversee Corrective and Preventative Action Plans as needed.
• Train research staff in governance, regulations and standard operating procedures.
• Prepare the Trust for regulatory inspections (e.g. MHRA).
• Collaborate with grants & contracts, delivery, CROs and CTU to support portfolios.

Skills

Research methodology

GCP knowledge

Research governance

Quality assurance

Monitoring experience

IRAS familiarity

CPD commitment

Training in monitoring

Education

Degree level education

Relevant research experience

Tools

IRAS

Job description

University Hospital Southampton NHS Foundation Trust invites applications for a Sponsorship Portfolio Manager within the Research & Development Department. The role oversees sponsor oversight for Trust-sponsored studies and ensures compliance with legislation and guidance.

The position involves developing oversight processes, advising researchers, and coordinating with grants, contracts, CROs and CTU. On-site work is required at least two days per week with flexible options where service needs