Full Clinical Research Analyst II

Com um legado único em dermatologia e décadas de inovação de ponta, a Galderma é a líder emergente na categoria de dermatologia, presente em aproximadamente 90 países. Oferecemos um portfólio inovador baseado na ciência de marcas premium e serviços que abrangem todo o espectro do mercado de dermatologia em rápido crescimento através de Estética Injetável, Cuidados Dermatológicos e Dermatologia Terapêutica. Desde a nossa fundação em 1981, dedicamos nossa atenção e paixão ao maior órgão do corpo humano - a pele - atendendo às necessidades individuais de consumidores e pacientes com resultados superiores em parceria com profissionais de saúde. Porque entendemos que a pele em que estamos molda nossas vidas, estamos avançando na dermatologia para cada história de pele.

About Galderma

Galderma is the leading company dedicated to dermatology, present in approximately 90 countries. We provide an innovative, science-based portfolio of premium brands and services that cover the full spectrum of the rapidly growing dermatology market through Injectable Aesthetics, Dermocosmetics, and Therapeutic Dermatology. Since our founding in 1981, we have dedicated our focus and passion to the largest organ of the human body – the skin – meeting the individual needs of consumers and patients with superior outcomes in partnership with healthcare professionals. We are advancing dermatology for every skin story because we understand that the skin we are in shapes our life stories.

Working at Galderma

At Galderma, you will have the ultimate opportunity to gain transformative work experiences. We are committed to meeting the individual needs of consumers and patients, with superior outcomes, in partnership with healthcare professionals. In our company, we embrace differences and respect the diversity, privacy, and personal rights of each employee. We are committed to maintaining a respectful and inclusive workplace. We take pride in our dedication to diversity and inclusion and want to ensure that the people we do business with know, share, and respect our standards.

If you seek to put your ideas into practice, make a difference, and fulfill your purpose, your place is here.

Opportunity – Key Responsibilities

What you will do:

The Clinical Study Analyst serves as an internal expert, under the direction of the Medical Manager, who focuses on monitoring and supporting the generation of local and regional clinical studies aiming to improve the quality of the scientifically generated data which is fundamental to increase our product scientific differentiation. The generation of scientific evidence through laboratorial, IIS, phase IV and III, cosmetic, bioequivalence or real-world evidence studies and also publications aims to increase the recognition of the local and regional medical excellence.

• Provide input to monitoring Clinical Development programs Injectable Aesthetics, Therapeutic Dermatology and Dermatological Skincare business units.
• Site evaluation/selection, regulatory/ethical submissions start-up, site engagement, monitoring, and site closure.
• Conduct on-site and remote monitoring visits of trial locations to review ethical and regulatory documentation, drug storage procedures, equipment calibrations, etc. Identify any deficiencies or training issues when applicable.
• Provide local regulatory and legal requirement expertise, attending all needed association and syndicate meetings.
• Author SOPs, process documents, and training materials to be key Clinical Development activities to resolve operational aspects of clinical trials in conjunction with project teams and Global teams in accordance with standard operating procedures (SOP), national and international good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets.
• Ensure ethical guidelines, safety regulations, and GCP principles are strictly followed across all trial locations and sponsor documents.
• Support sponsor to regulatory inspections; may participate or present in inspections.
• Ensure to be updated and compliant with all local and international ethical, regulatory and legal requirements under sponsor needs.

Education, Knowledge, Skills & Abilities

• Medical doctor or healthcare professional or Advanced degree required.
• Minimum of 5 years in positions such clinical study analyst.
• Excellent written and verbal communication skills required.
• Meeting planning and facilitation skills required.
• Strong analytical, organization and project management skills required.
• Experience with medical writing skills is preferred, not required.

Competencies & Attributes

• Ability to think strategically to guide Clinical studies and scientific publication-related activities in accordance with industry standards and good publication practices.
• Must be able to function in a team-oriented (matrix) environment.
• Must be able to plan and monitor strategic projects anticipating potential needs.
• Must have a successful track record demonstrating the ability to team-work, organize, prioritize, solve problems and work effectively in a constantly changing environment.
• Ability to develop good relationships and credibility with peers and stakeholders.
• Advanced English required.

BENEFITS:

• Meal and Food Allowance
• Mobility/Parking Allowance
• Life Insurance
• Medical Assistance
• Dental Assistance
• Childcare Assistance
• Annual Bonus
• Private Pension Plan
• Pharmacy Agreement
• Gympass
• Birthday Day Off
• Paternity Leave – 30 days
• Maternity Leave – 6 months
• Discount Club
• 100% Company-Subsidized Products
• Home Office (2 days home, 3 days office)
• Short Friday