Clinical Lead III (Rare Disease)

30.01 Premier Research Group (India) Private Limited; Golden Horseshoe; On-site; CAD 90,000 - 130,000; Full time

Job summary

A prominent clinical research company seeks a Clinical Lead III specializing in Rare Diseases to drive clinical study efficiency and oversight. The role requires a Bachelor's degree in a relevant field, and significant clinical research experience, including leadership in clinical trial management. Ideal candidates will possess expertise in rare diseases and risk management, contributing significantly to medical innovation. Comprehensive onboarding, career growth opportunities, and a commitment to work-life balance are integral to the company's culture.

Qualifications

• Bachelor’s degree or equivalent in a clinical, biological, or health-related field.
• 9 years of clinical research experience, with 4 years in monitoring.
• Experience in Rare disease studies and trial management required.

Responsibilities

• Drive global study and program clinical team efficiency.
• Oversee clinical team tracking and analysis.
• Support financial health of clinical activities.

Skills

Clinical research experience

Team leadership

Risk management

Financial oversight

Communication skills

Education

Bachelor’s degree in clinical or biological field

Job description

Clinical Lead III (Rare Disease) page is loaded

Clinical Lead III (Rare Disease)

Apply remote type: Remote | locations: Canada | time type: Full time | posted on: Posted 2 Days Ago | job requisition id: R5458

Premier Research is looking for a Clinical Lead III (Rare Disease) to join our Global Clinical Management team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech. Join us and build your future here.

What You'll Be Doing

• Act as a leader driving global study and/or program clinical team and departmental engagement, maximizing the efficiencies of the clinical team across studies/programs.
• Oversee clinical team tracking and analysis of open action items, protocol deviations, and communication reports.
• Complete or contribute to the review of the protocol/study design, informed consent forms, case report forms, and other study documents/plans, or delegate to the assigned CL.
• Apply a risk-based quality management mindset, contribute to the risk management plan, and support setup of adaptive risk monitoring system with the study team as applicable.
• Work with all functional leads and sponsor to identify data-related issues and risks to clinical activities; assist CLs in developing mitigation plans to minimize risk.
• Support the PM, regional CLs, and/or appropriate line managers to ensure team members are adequately resourced for the entire study duration.
• Oversee the financial health of clinical activities, including support in identifying out-of-scope tasks and ensuring pre-approval by the PM and Sponsor, as required.

What We Are Searching For

• Bachelor’s degree or its international equivalent in a clinical, biological, scientific, or health-related field; or equivalent work experience.
• 9 years of clinical research experience as a CRA, CL, or PM, with at least 4 years of clinical monitoring experience.
• 4 or more years of previous Clinical Oversight/Trial Management experience, with global experience valued.
• Rare disease study experience is required, with preference for additional Cell & Gene Therapy experience.
• Experience with presenting at bid defense meetings is highly prioritized.
• Experience with study start-up activities for site activation is preferred.