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Site Readiness Specialist

Panthera Biopartners
GBR
Full-time
Hybrid
£35,000 to £40,000
Discovered 1 months ago
Clinical operationsStudy start-upSite managementICH GCPClinical trial regulationsInspection readiness

Full Job Posting

About Panthera Biopartners

Panthera is an independent Site Management Organisation helping pharmaceutical and contract research organisations find suitable patients for clinical trials.

The organisation focuses on patient experience and environments for volunteers and participants.

Role Overview

The Site Readiness Specialist - Study Start-Up supports operational readiness and study start-up activities for successful clinical study activation and execution.

The role connects project teams, site operations, and external partners across operational, regulatory, quality, and recruitment readiness.

The position is based in the Fulwood head office on a hybrid basis and may occasionally support other Panthera sites.

Salary and Benefits

  • The advertised pay range is £35,000 to £40,000 GBP per year, with the description also stating a salary of up to £40,000.
  • Benefits include annual leave, life insurance, healthcare cash plan, employee assistance, family-friendly policies, an electric car scheme, and an annual self-care day.

Operational Readiness and Study Start-Up

  • Develop study-specific start-up documents and operational pathways so sites meet requirements before activation.
  • Align readiness plans with project timelines, risk mitigation strategies, and critical path activities.
  • Maintain readiness checklists, mock visits, diary management quality checks, and operational walkthroughs.
  • Ensure facilities, equipment, laboratories, pharmacy operations, and supporting services meet protocol requirements.
  • Own health and safety reviews, risk assessments, and training requirements for new studies.

Vendors and Project Coordination

  • Support identification and evaluation of external clinical vendors and raters.
  • Act as an operational contact for vendors, resolving issues and driving continuous improvement.
  • Liaise between site operations and project teams and escalate risks or issues proactively.
  • Participate in project meetings to identify roadblocks and align milestones, risk indicators, and intervention plans.

Training

  • Support site training strategies covering protocol requirements, safety reporting, source documentation, and operational workflows.
  • Keep training materials aligned with protocol amendments, sponsor expectations, and risk mitigation strategies.

Key Skills

  • Experience in clinical operations, study start-up, or site management within clinical research is required.
  • Strong working knowledge of ICH GCP, clinical trial regulations, and inspection readiness requirements is required.
  • Applicants should be able to manage multiple studies, stakeholders, and competing priorities.
  • A bachelor's degree in life sciences, healthcare, nursing, or a related field is preferred.
  • The role requires a patient-centric mindset and strong attention to quality, compliance, and detail.

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