Company Name: Certara | Location: Paris | Type: Job | Last Date to Apply: 2021-02-20
At Certara, we accelerate medicines to patients by partnering with life science innovators.
Our Integrated And Proprietary End-to-end Platform With Bio Simulation, Regulatory Science, And Market Access Solutions Combined With Our Strong Team Of Scientists And Subject Matter Experts Enable Our Clients To Have
In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services.
Informed decision-making & reduced clinical trial burden Higher R&D productivity Improved patient outcomes & increased patient access to medicinesAccelerated regulatory approval
Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.
Together with our partners, we use bio simulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.
We are seeking to appoint an organized, flexible Clinical Research Associate (CRA) specialized in observational and real world evidence studies, to join our Clinical Operations Team. The successful candidate will work closely with a team of highly skilled epidemiologists, statisticians, health economists and consultants.
Main Tasks & Responsibilities
Maintaining oversight on site related activities throughout the life cycle of project performing: Site Selection; Start-up/regulatory; Site Initiation; Monitoring activities; Close out visits plus maintaining appropriate documentationManage the relations with the clinical centers with ad hoc remote and on-site monitoring Manage the progress of assigned studies on recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.Manage the regulatory submissions and approvals of the assigned studies in an international framework by completing the application to Ethics Committee/IRB and preparing necessary
documentation enclosed to the application according to local requirements and in cooperation with Project Manager.Manage contracts and payments with the centers of the assigned studies, in cooperation with Project Manager and Finance and Legal departments.
Required Qualifications / Experience
A Masters’ degree in the Life SciencesMinimum 3 years of prior work experience as a Clinical Research Associate; startup of projects including regulatory submission process. Minimum 1+ year of experience in Independent MonitoringPrevious experience/work in several 5 EU countries is a plus.Possess the understanding of Good Clinical Practice regulations and ICH guidelines
Professional proficiency in English, written and spoken. Any other language is a plus.Ability to work both independently and as part of the teamAbility to effectively prioritize and manage multiple tasks and projectsAbility and willingness to travel in accordance with company and project requirementsGood interpersonal skills demonstrated as proactive and enthusiastic
Number of Employees Supervised: None
Percentage of Travel Required:10% travel
Place of work: Home-based/Office (depending on location)
Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.