Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
true
Sr Manager, External Research Program (ERP)
Posted: 11/19/2024
2024-11-19
2025-01-04
Employment Type:
Contract
Job Category: Project Management
Job Number: 616141
Is job remote?: No
Country: United States
Job Description
Target PR Range: 72-82/hr
*Depending on experience
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 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
*Depending on experience
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 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
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