Lead CRA- International Observational Studies

** Job Description*
* 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 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.

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** 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.

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** 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.

+  
** Conduct Feasibility Assessments:
** Organize, identify and manage the feasibility process with CRA's.

+  
** 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.

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** 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.

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** Travel for site initiations, closures or quality visits:
** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required.

** 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.

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** 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.

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** Communication skills** :
Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset.

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** Technical proficiency** :
Comfort with MS Office, EDC, CTMS experience and willingness to learn and handle various technical systems and tools.

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** Personal qualities** :
Exceptional organizational and problem-solving skills, strong cross-cultural team work, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment.

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** Financial management:
** Experience reviewing site contracts, budget and invoices.

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** Attention to detail** :
Ability to work independently with careful, precise, and thorough execution of complex tasks.

** 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.

+  
** Conduct Feasibility Assessments:
** Organize, identify and manage the feasibility process with CRA's.

+  
** 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…