Site Readiness Specialist

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

Benefits offered by this job

25 days’ annual leave

Annual Leave Buy and Sell Scheme

Life insurance at 3x annual salary

Healthcare cash plan

Employee Assistance Programme

Enhanced sickness and family-friendly"

Electric Car Scheme

Annual Self-Care Day

Job summary

Panthera Biopartners seeks a Site Readiness Specialist to drive operational readiness and study start-up activities across multiple studies from our Fulwood Head Office on a hybrid basis.

You will bridge project teams, site operations and external partners to ensure regulatory, quality and recruitment readiness prior to site activation, while supporting other Panthera sites as needed. You will own readiness checklists and coordinate risk assessments to ensure protocol alignment.

Qualifications

• Bachelor’s degree in life sciences, healthcare, nursing or related field required.
• Experience in clinical operations, study start-up or site management in clinical research.
• Strong knowledge of ICH GCP and inspection readiness.

Responsibilities

• Lead operational readiness and start-up activities to ensure site activation.
• Develop and train study-specific start-up documents and Panthera pathways.
• Coordinate with project managers to align readiness plans with timelines and risk plans.
• Maintain site readiness checklists, mock visits and quality reviews.
• Ensure facilities, labs, pharmacy operations and services align with protocols.
• Support health and safety reviews and training requirements for new studies.
• Liaise with external vendors and act as operational point of contact.

Skills

ICH GCP knowledge

Clinical operations experience

Study start-up

Project coordination

Stakeholder management

Attention to detail

Education

Bachelor’s degree in life sciences or healthcare

Job description

Site Readiness Specialist - Study Start Up

An exciting opportunity has become avaliable for a Site Readiness Specialist to join our Head Office Team, In Fulwood, on a Hybrid basis! The Site Readiness Specialist is responsible for operational readiness and study start-up activities to ensure successful site activation and execution of clinical studies. This role acts as the bridge between project teams, site operations, and external partners, ensuring operational, regulatory, quality, and recruitment readiness across multiple studies.

There may occasionally be a requirement to support other Panthera sites.

Salary & Key Benefits:

• Salary up to £40,000
• 25 days’ annual leave plus bank holidays, increasing with length of service
• Annual Leave Buy and Sell Scheme
• Life insurance at 3x annual salary
• Employee healthcare cash plan
• Employee Assistance Programme
• Enhanced sickness and family-friendly policies
• Electric Car Scheme
• Annual Self-Care Day

Key Responsibilities

• Operational Readiness & Study Start-Up
• Contribute to operational readiness for new studies with the development of all Panthera study specific start up documents to ensure sites meet all operational, regulatory, and quality requirements prior to site activation.
• Contribute to the development of the Panthera operational pathway for each study ensuring this is trained to all selected sites.
• Collaborate closely with project managers to align site-level readiness plans with project timelines, risk mitigation strategies, and critical path activities.
• Own and maintain site readiness checklists, mock visits, diary management quality checks and operational walkthroughs reporting back to the PM on progress.
• Ensure facilities, equipment, laboratories, pharmacy operations, and supporting services are fully aligned with protocol requirements prior to activation.
• Own Health and Safety review of new studies and associated risk assessments and training requirements.
• Support in the identification and evaluation of external vendors (e.g., clinical vendors, raters).
• Support as operational point of contact for external vendors, proactively identifying risks, resolving issues, and driving continuous improvement.
• Serve as the operational liaison between site operations and internal project teams, ensuring clear communication and proactive escalation of risks or issues. Panthera Biopartners Ltd Controlled Document JD_HR_Oct24_V1.0
• Participate in project team meetings to identify operational roadblocks, and align on study milestones, risk indicators, and intervention plans.
• Support in the development site training strategies covering protocol requirements, safety reporting, source documentation, and operational workflows.
• Partner with project teams to ensure training materials remain aligned with protocol amendments, sponsor expectations, and risk mitigation strategies.

Key Skills

• Ideally Bachelor’s degree in life sciences, healthcare, nursing, or a related field Experience in clinical operations, study start-up, or site management within clinical research.
• Strong working knowledge of ICH GCP, clinical trial regulations, and inspection readiness requirements.
• Demonstrated ability to manage multiple studies, stakeholders, and competing priorities.
• Patient-centric mindset with strong advocacy focus
• High attention to quality, compliance, and detail

We are an equal opportunity employer and consider all qualified applicants equally without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran status or disability status.

AI - Please note, AI may be used in our recruitment process however all CV's are manually viewed by the team.

Panthera Biopartners

Panthera is an independent Site Management Organisation helping pharmaceutical and contract research organisations find the right patient, for the right trial, at the right time. The Panthera team is run by a world-class team of experts with more than a hundred years of clinical research experience.

We put the patient at the heart of everything we do to ensure the best experience and environment for volunteers and participants. Accelerating clinical breakthrough for our customers, our patients, and for future generations.

The pay range for this role is:

35,000 - 40,000 GBP per year (Head Office)