Senior Manager, Medical Research

Overview

• Lead operational execution and oversight of Investigator Initiated Studies and Research Collaborations in a dynamic, global environment.
• Serve as a central contact for investigators, internal teams, and vendors, ensuring high-quality research execution.
• Coordinate study lifecycle activities, including concept intake, review, contracting, execution, and close-out.
• Collaborate with cross-functional teams to maintain inspection readiness and support audits and inspections.
• Manage IIS and RC budgets, ensuring compliance with local/regional requirements and quality standards.
• Contribute to initiatives aimed at improving investigator experience and internal efficiencies.
• Uphold and model core values in all aspects of work, fostering a collaborative environment.
• Hybrid work arrangement offering flexibility and engagement with global teams.

Key Responsibilities & Duties

• Act as the primary contact for IIS and RC activities across multiple regions.
• Manage relationships with investigators, academic partners, and internal stakeholders.
• Coordinate Medical Affairs Review Board meetings, including agenda development and document preparation.
• Track IIS/RC metrics and provide updates to Medical Affairs leadership.
• Collaborate with GPSRM and QA teams to support audits and inspections.
• Ensure compliance with drug shipment activities and quality standards.
• Identify operational challenges and propose practical solutions to improve processes.
• Provide oversight for IIS portal vendor issues and updates.

Job Requirements

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
• Minimum of 5 years of experience in pharmaceutical/biotech industry; 7 years preferred.
• Proven expertise in Clinical Operations and Medical Affairs supporting GCP/GPP studies.
• Strong knowledge of ICH/GCP, regulatory guidelines, and clinical research processes.
• Excellent communication skills and stakeholder management capabilities.
• Highly organized, detail-oriented, and able to work independently.
• Solution-oriented mindset with strong problem-solving skills.
• Hybrid work arrangement requiring adaptability and collaboration with global teams.