Senior Lead Clinical Research Associate – NIS
- Compensation
- Not disclosed
- Location
- United Kingdom
- Work setup
- Not specified
- Seniority
- Lead
- Employment
- Contract
- Experience
- 2+ years
- Category
- Healthcare
- Posted
Skills
Must have
- Education: Bachelor’s degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years’ hands-on clinical research experience.
- Clinical research expertise: At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studie
- Lead CRA experience: Minimum 2 years of experience as a Lead CRA, leading and coordinating CRA activities across multiple countries in Europe, with responsibility for study delivery, CRA oversight and
- Communication skills: Outstanding spoken and written proficiency in English (C1 level minimum). Additional languages are considered a strong asset.
- Technical proficiency: Comfort with MS Office, EDC, CTMS experience and willingness to learn and handle various technical systems and tools.
- Personal qualities: Exceptional organizational and problem-solving skills, strong cross-cultural
- Financial management: Experience in reviewing site contracts, budget and invoices.
- Attention to detail: Ability to work independently with careful, precise, and thorough execution of complex tasks.
Full description
Oracle Life Sciences empowers pharmaceutical, biotechnology, medical device companies, and clinical research organizations to bring therapies to market faster and more efficiently. We are helping organizations accelerate innovation and improve health outcomes for patients worldwide.
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us!
As a global leader we’re looking for a Senior Lead Clinical Research Associate (CRA) to drive success as part of our Non-interventional Study team.
Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale!What you will doAs a Senior Lead Clinical Research Associate at Oracle, you will:
- Drive study start-up: Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors.
- Oversee contracts and budgets: Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters.
- Ensure regulatory compliance: Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents.
- Lead study site management: Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans.
- Train and coordinate CRAs: Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management.
- Monitor progress and quality: Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports.
- Foster team collaboration: Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement.
Required Experience
- Education: Bachelor’s degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years’ hands-on clinical research experience.
- Clinical research expertise: At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies.