Study Start-Up & Site Readiness Specialist

Panthera Biopartners; England; Hybrid; GBP 35,000 - 40,000; Full time

Benefits offered by this job

25 days annual leave

Bank holidays

Life insurance 3x salary

Healthcare cash plan

Employee Assistance Programme

Enhanced sickness & family-friendly

Electric Car Scheme

Annual Self-Care Day

Job summary

Panthera Biopartners is seeking a Site Readiness Specialist - Study Start Up to join our Head Office team in Fulwood on a hybrid basis. You will drive operational readiness, develop start-up documents, and ensure sites meet regulatory, quality, and safety requirements before activation.

Collaborate with project managers to align site readiness with study timelines, risk mitigation, and critical path activities. This role may support other Panthera sites as needed.

Qualifications

• Proven experience in clinical operations and study start-up activities.
• Strong knowledge of ICH GCP and trial regulations.
• Ability to align site readiness with project timelines and milestones.
• Experience managing multiple studies and stakeholders.

Responsibilities

• Lead operational readiness and study start-up activities to ensure sites meet regulatory and quality requirements prior to activation.
• Develop and train sites on the operational pathway for each study.
• Collaborate with project managers to align site readiness with timelines and risk plans.
• Own site readiness checklists, mock visits, and quality checks; report progress to PMs.
• Ensure facilities, labs, pharmacy operations, and supporting services meet protocol requirements before activation.
• Support health and safety reviews, risk assessments, and training needs for new studies.
• Assist in vetting external vendors and act as operational point of contact to mitigate risks.
• Attend project team meetings to identify roadblocks and set intervention plans.
• Help develop site training strategies aligned with protocol amendments and sponsor expectations.

Skills

ICH GCP knowledge

Clinical operations

Study start-up

Site management

Stakeholder management

Attention to detail

Education

Bachelor’s degree in life sciences or related field

Clinical research training

Job description

Panthera Biopartners is seeking a Site Readiness Specialist - Study Start Up to join our Head Office team in Fulwood on a hybrid basis. You will drive operational readiness, develop start-up documents, and ensure sites meet regulatory, quality, and safety requirements before activation.

Collaborate with project managers to align site readiness with study timelines, risk mitigation, and critical path activities. This role may support other Panthera sites as needed.