Sr Manager, External Research Program (Oncology/ Investigator-sponsored) - 100% REMOTE
Salary undisclosed
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Sr Manager, External Research Program (ERP) - Oncology
Client’s External Research Program (ERP) advances our enterprise portfolio through external innovation and data generation. This role will manage operations and track progress for investigator-sponsored and collaborative studies across our evolving portfolio.
Key Responsibilities
- Manage day-to-day administration and operations for ISRs and collaborative studies from concept approval to study closure:
- Plan the external project timeline and regularly monitor adherence, metrics, and progress throughout the study lifecycle
- Partner with global, regional, and local Medical Affairs teams, Translational Medicine, Safety to review protocols and research plans
- Work with client partners to carry out budget analyses, regulatory submission support and contract negotiations
- Support clinical demand accuracy, clinical logistics preparation and Tech Ops readiness efforts by tracking institutional start up activities and ensuring timely progress
- Work with institutional contacts to reliably maintain study data in iEnvision platform to ensure single source of truth
- Monitor study milestones (e.g., deliverables, enrollment status, publications) and process monthly invoicing to support financial forecast accuracy
- Ensure effective, accurate, and timely communication to meet the needs of internal and external stakeholders
- Proactively identify gaps in SOP and prepare updates to ERP playbook to address gaps or reflect process improvements and changes
- Produce monthly leadership reports to illustrate the evolving ERP portfolio
- Communicate frequently with external institutions to assure compliance with research activities and provides direction for those institutions regarding research, contractual, and milestone compliance, recruitment, and reporting
Basic Qualifications
- Master’s and 4+ years of experience in the pharmaceutical industry/project management
OR
- Bachelor’s with 6+ years of experience in the pharmaceutical industry/project management
OR
- Associate and 8+ years of experience in the pharmaceutical industry/project management
OR
- High School Diploma/GED and 10+ years of experience in the pharmaceutical industry/project management
Preferred Qualifications
- Good understanding/experience in clinical and/or pre-clinical research, or experience in Clinical Research/Development, Medical Affairs
- Established communication, project management, problem solving, and organizational skills, including management of multiple priorities and resources while maintaining attention to detail
- Proactive, self-motivated, and resourceful – able to cultivate path forward in ambiguous circumstances and know when to ask for support or escalation
- PMP or equivalent project management qualification an advantage
- Experience of working in an international environment and distributed workforce an advantage
- Affinity for a collaborative, team-oriented environment, and approach; ability to appropriately interact within Global Medical Affairs and across diverse departments, senior management, and external customers/vendors
- Comfortable synthesizing information to support leadership presentations and memos
- Knowledge and skill with Smartsheet, Microsoft Excel, Word, PowerPoint, Visio, and other reporting and tracking tools
Sr Manager, External Research Program (ERP) - Oncology
Client’s External Research Program (ERP) advances our enterprise portfolio through external innovation and data generation. This role will manage operations and track progress for investigator-sponsored and collaborative studies across our evolving portfolio.
Key Responsibilities
- Manage day-to-day administration and operations for ISRs and collaborative studies from concept approval to study closure:
- Plan the external project timeline and regularly monitor adherence, metrics, and progress throughout the study lifecycle
- Partner with global, regional, and local Medical Affairs teams, Translational Medicine, Safety to review protocols and research plans
- Work with client partners to carry out budget analyses, regulatory submission support and contract negotiations
- Support clinical demand accuracy, clinical logistics preparation and Tech Ops readiness efforts by tracking institutional start up activities and ensuring timely progress
- Work with institutional contacts to reliably maintain study data in iEnvision platform to ensure single source of truth
- Monitor study milestones (e.g., deliverables, enrollment status, publications) and process monthly invoicing to support financial forecast accuracy
- Ensure effective, accurate, and timely communication to meet the needs of internal and external stakeholders
- Proactively identify gaps in SOP and prepare updates to ERP playbook to address gaps or reflect process improvements and changes
- Produce monthly leadership reports to illustrate the evolving ERP portfolio
- Communicate frequently with external institutions to assure compliance with research activities and provides direction for those institutions regarding research, contractual, and milestone compliance, recruitment, and reporting
Basic Qualifications
- Master’s and 4+ years of experience in the pharmaceutical industry/project management
OR
- Bachelor’s with 6+ years of experience in the pharmaceutical industry/project management
OR
- Associate and 8+ years of experience in the pharmaceutical industry/project management
OR
- High School Diploma/GED and 10+ years of experience in the pharmaceutical industry/project management
Preferred Qualifications
- Good understanding/experience in clinical and/or pre-clinical research, or experience in Clinical Research/Development, Medical Affairs
- Established communication, project management, problem solving, and organizational skills, including management of multiple priorities and resources while maintaining attention to detail
- Proactive, self-motivated, and resourceful – able to cultivate path forward in ambiguous circumstances and know when to ask for support or escalation
- PMP or equivalent project management qualification an advantage
- Experience of working in an international environment and distributed workforce an advantage
- Affinity for a collaborative, team-oriented environment, and approach; ability to appropriately interact within Global Medical Affairs and across diverse departments, senior management, and external customers/vendors
- Comfortable synthesizing information to support leadership presentations and memos
- Knowledge and skill with Smartsheet, Microsoft Excel, Word, PowerPoint, Visio, and other reporting and tracking tools