Senior Lead Clinical Research Associate – NIS

Job 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!

Responsibilities

What you will do As 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.

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 quality across assigned sites.

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. teamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment.