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Ass. Dir, Head of Informed Consent
Posté 23 mai 2023
Bangalore, Karnataka - India
Demander un identifiant 264539
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
- Take the lead and be the business process owner for Informed Consent Management and define process goals, design and document business requirements, ensure harmonization and standardization of the process and ensure process optimization.
- Drive the development of Master ICF/s and subsequent amendments, in Phase I-IV studies, with internal and external business partners, in accordance with the requirements of quality, ethical and regulatory standards.
- Oversee the implementation of eConsent at trial level and oversight of vendors providing such services.
- Manage a small team of ICF specailists and develop them in their role and responsiblitiles.
- Engage in standard methodologies sharing and continue to keep up to date with current practices in the site start-up activities, innovations & technologies and regulatory changes.
Who You Are:
- Medical or Life Sciences degree, or relevant qualification, with Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM certification (CPM, PMP) desirable.
- Extensive clinical knowledge and experience in clinical development/ operations with experience in study start-up or regulatory space. Experience in the development of ICF and eConsent processes preferred.
- Excellent project, partner and organizational change manager
- Strong interpersonal capabilities - verbal, written and listening, both in native language and English
- Critical thinking and proactive approach
- Fail fast and data driven mentality as well as agile methodology
- Strong data insights and analytical skills to identify trends and drive quality/process improvements.
- Adapt well to changes in assignment and priorities; and ability to adapt behavior or work methods in response to new information, changing conditions or unexpected obstacles.
- Ability to make risk-based decisions based on a robust benefit/risk assessment.
- Ability to work in a fast paced, matrixed, multinational work environment, encouraging partnership within and across functional areas.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!