Develop training and drive change management for new global clinical trial regulations processes.
Manage and coordinate redaction of clinical documents per EMA, Health Canada, EU CTR, and other regulations.
Collaborate with Global Development Operations, Biostatisticians, Medical Writing, Submission Managers, and stakeholders to operationalize redaction requirements.
Provide vendor and CRO oversight for document redaction and data sharing.
Work with IT to implement technology solutions for clinical trial disclosure.
Manage and track redaction book-of-work and compile performance metrics.

Job Requirements

MA/MS in a scientific or medical field is required; BA/BS with 5 years relevant scientific or medical work experience is also considered.
2-3 years of transparency (clinical trial disclosure) experience is preferred.
Possess a deep understanding of US, Canada, and EU clinical trial disclosure regulations and policies.
Demonstrate comfort working with and discussing scientific data.
Exhibit strong project and stakeholder management skills.
Ability to work independently and proactively seek support when needed.
Exceptional written and oral communication skills are essential.
Strong organizational skills, able to multitask and prioritize effectively.

About Company

Bristol Myers Squibb (BMS) promotes a challenging, meaningful, and life-changing work environment, emphasizing balance, flexibility, and employee growth. Employees are empowered to participate in clinical trials globally and are expected to uphold BMS values: passion, innovation, urgency, accountability, inclusion, and integrity.

On-site protocol: 100% onsite. Site-by-design: Hybrid (50% onsite). Field-based/Remote-by-design: Ability to travel for work-related visits and meetings as required.

Data privacy policies apply to all recruitment processes. Qualified applicants with arrest or conviction records will be considered per local laws. Employees are strongly recommended to maintain up-to-date COVID-19 vaccinations.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

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Manager, Clinical T