Clinical Operations Support Expert (Study Start Up) / EF / São José dos Campos,SP

Clinical Operations Support Expert (Study Start Up) / EF / São José dos Campos,SP

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If you’re someone who wants to shape your own path, who values creativity and brings a spirit of innovation – you’ll feel right at home here. Come be part of this journey. Be yourself. We are Bayer.

GET TO KNOW OUR AREA:

The COS is a local role that provides end-to-end operational support during the lifecycle of assigned Phase I-IV studies. The COS operates in line with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements and Bayer’s standard operating procedures.

YOUR MISSION WILL BE TO:

The COS will be assigned work packages in areas of study start-up, study support, and site management activities. Work packages are allocated to the position holder according to skill set and capacity requirements in a flexible way. The COS will acquire knowledge and be provided adequate training to support independent execution of work packages assigned.

A work package is any combination of the individual responsibilities listed below. Work packages are not fixed, can be allocated per study, and distributed within the team. Allocation and distribution of responsibilities must adhere to Bayer’s standard operating procedures, including any requirements for independent review and oversight.

STUDY START-UP & SUPPORT

1. Execute study start-up activities in collaboration with local team including, e.g.:
   1. Execute CDA;
   2. Ensure local translations​ completed.
   3. Compile and distribute ISF documents​.
   4. Manage greenlight process​.
   5. Conduct debarment checks.​
   6. Support site activation planning (i.e. potential sites for early activation).
2. Conduct local document quality checks​.
   
   
3. Coordinate provision/return/destruction of study supplies (e.g. PRR materials, Kits4Life, kits, etc.)​.
4. Maintain study-relevant systems (incl. Gemstone, vendor systems and tools). Ensuring data and document completeness and quality at the site and country level.
5. Complete relevant post-site closeout visit activities (e.g. ensure provision of EOSPDF, treatment allocation, related tasks)

QUALITY

1. Proactively identify and communicate issues, taking appropriate action to prevent recurrence of identified deviations. Ensure timely and comprehensive resolution of issues that may affect compliance or the quality of study related activities or data;
2. Contribute to the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome.

ARE YOU READY FOR THE POSITION?

Must have:

• Bachelor’s degree in a health-related field, or equivalent combination of education and experience.
• Previous experience in the Study Start-Up phase of clinical trials, including preparation and submission of regulatory dossiers, Institutional Review Board (IRB)/Ethics Committee submissions, and review of Informed Consent Forms (ICFs).
• Experience with regulatory packages and essential regulatory documents.
• Advanced knowledge in English and Portuguese.
• Be available to go to the São José dos Campos, SP office at least once a week.
• Oral presentation & interpersonal skills.
• Awareness & understanding of cultural and regional differences.
• Planning and organization, time management, prioritization.
• Be able to work independently; have critical thinking and issue resolution.
• Thrives in ambiguous and collaborative environments and embraces change.
• Willingness to travel when business requires (e.g. office meetings, study meetings, local and/or international level).

Nice to Have:

• Experience using the Veeva system
• Experience with U.S. regulatory packages and essential regulatory documents.

What else you'll find here:

At Bayer, we care deeply about the well-being of our people. That’s why our benefits are built around three essential pillars: integrated health, financial well-being, and life balance. Together, they support a healthier, more fulfilling life – inside and outside of work.

Here’s a glimpse of what we offer:

• Encouragement for a healthy lifestyle
• Support in identifying and monitoring physical and mental health risks
• Initiatives focused on health promotion, prevention, and care
• Real balance between personal and professional life
• Guidance for personal financial planning
• Insurance and private pension plans to help you build a secure future

And of course, we also offer a full range of market-standard benefits, including medical and dental care, life insurance, meal benefits, and Wellhub (formerly Gympass).

What makes us different:

• Flexible/hybrid work model*
• Short Fridays and extended holiday breaks*
• Flexible vacation planning (within legal guidelines)
• Language courses – Free access to standard courses through our partner Education First (EF), in multiple languages like English, Spanish, German, French, Portuguese, and Swedish
• Pharmacy subsidy – 50% discount on Bayer over-the-counter products, and full coverage for prescription Bayer medications
• Conte Comigo – A support program offering psychological assistance, help with substance dependency, and legal and financial counseling
• Bem Nascer – A special package of exclusive benefits for new parents
• Childcare assistance – Additional support for parents welcoming a new child
• Parental leave – A benefit designed to strengthen family bonds, offering equal opportunities for all parents, regardless of gender identity or family structure
• Private pension plan – A long-term savings plan with a 200% company match on your contributions

*Benefits may vary depending on your role and location.

Período disponível para candidatura:21/09/26 até 06/10/26Referência:873668 Local:Brasil : São Paulo : São José dos Campos Área Funcional:Desenvolvimento Clínico e Operações Grupo de Contratação:Regular Horário de Trabalho:Administrativo - Híbrido.