Clinical Trial Posting Expert

Bayer; Barcelona; Presencial; EUR 45.000 - 75.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Clinical Trial Posting Expert to oversee the management and disclosure of clinical trial information. This role is pivotal in ensuring compliance with internal and external regulations while maintaining high-quality standards in data management. You will collaborate with various departments, including R&D and Legal, to develop and implement disclosure strategies. If you have a strong background in clinical trial processes and a passion for regulatory compliance, this opportunity offers a meaningful career path in a dynamic environment dedicated to health advancements.

Formación

• 3-5 years of experience in clinical trial disclosure.
• Deep understanding of global legislations and ICH/GCP regulations.

Responsabilidades

• Supervise and manage clinical trial information disclosure.
• Ensure compliance with internal processes and external regulations.
• Monitor evolving disclosure requirements and update strategies.

Conocimientos

Clinical Trial Disclosure

Data Management

Quality Assurance

Regulatory Compliance

Communication Skills

Educación

Degree in Medicine

Degree in Life Sciences

Degree in Natural Sciences

Descripción del empleo

At Bayer, we’re visionaries driven to solve the world’s toughest challenges, striving for a world where 'Health for all, Hunger for none' is no longer just a dream but a reality. We approach this with energy, curiosity, and dedication, learning from diverse perspectives, expanding our thinking, and redefining what’s possible. If you’re eager to build a meaningful career in a community of brilliant, diverse minds to make a real difference, Bayer is the place for you.

Clinical Trial Posting Expert

Purpose :

1. Supervise, manage, and disclose clinical trial information on registries and websites according to internal rules and external regulations across Bayer’s product portfolio, ensuring regular updates and maintenance.
2. Manage internal requirements and external legal and regulatory obligations to develop and update Bayer’s clinical trial disclosure strategy.
3. Support understanding of clinical trial disclosure processes, provide training to involved departments as needed.
4. Disclose clinical trial information with high quality, fully complying with Quality Assurance processes.
5. Develop and implement related Quality Assurance processes.

Scope : Global

Key tasks :

1. Collect and supervise data necessary for public disclosure, design forms/templates, request information, track responses, and disclose information.
2. Ensure provision of up-to-date, consistent clinical trial data across all websites.
3. Perform and oversee quality control of disclosed information according to QA processes.
4. Check for consistency of information across sites and registry data.
5. Review disclosures for appropriate wording, avoiding promotional language.
6. Ensure compliance with internal processes and external legislations.
7. Monitor evolving disclosure requirements and update strategies and processes accordingly.

Key working relations :

The position involves direct interaction with R&D Leadership, Clinical Development and Operations heads, MA&Pv Leadership, Legal, Patents, Corporate Communications, and Investor Relations departments.

Qualifications & Competencies :

1. Graduate in Medicine, Life Sciences, or Natural Sciences, or equivalent professional experience.
2. At least 3-5 years of experience in clinical trial disclosure, with significant trial conduct and analysis experience.
3. 1-2 years in a senior clinical trial posting or trial disclosure role.
4. Deep understanding of global legislations, regulations, and guidelines; ability to interpret and comply with complex legal requirements.
5. Profound knowledge of ICH / GCP regulations.