Site Readiness Specialist

Panthera Bio; 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 3x salary

Healthcare cash plan

Employee Assistance Programme

Enhanced sickness and family-friendly

Electric Car Scheme

Self-Care Day

Job summary

Panthera Biopartners is seeking a Site Readiness Specialist for the Head Office in Fulwood (Preston) on a hybrid basis. You will drive operational readiness and study start-up activities to ensure site activation and successful execution of clinical studies.

You will coordinate with project teams, site operations, and external vendors to align readiness plans with timelines, risk mitigation, and quality requirements.

Qualifications

• Bachelor’s degree in life sciences, healthcare, nursing, or related field.
• Experience in clinical operations, study start-up, or site management.
• Strong knowledge of ICH GCP and trial regulations.
• Experience with inspection-readiness.
• Ability to manage multiple studies and stakeholders.

Responsibilities

• Oversee operational readiness and study start-up activities for new studies.
• Develop start-up documents to ensure sites meet regulatory, quality and operational requirements.
• Train sites on the Panthera operational pathway for each study.
• Collaborate with project managers to align site plans with timelines and risk strategies.
• Maintain site readiness checklists, mock visits, and quality controls across studies.
• Ensure facilities, equipment and labs meet protocol requirements prior to activation.
• Lead Health and Safety reviews and risk assessments for new studies.
• Support external vendors and act as operational contact to resolve issues.
• Act as liaison between site operations and internal teams with proactive risk escalation.
• Participate in project team meetings to identify roadblocks and milestones.
• Develop site training strategies aligned with protocol amendments and sponsor expectations.

Skills

Clinical operations

ICH GCP

Multiple studies

Patient-centric

Attention to detail

Education

Bachelor's degree in life sciences

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)