Sr Manager - Leadstack Inc
Santa Monica, CA 90404
About the Job
LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.
Job Title: Sr External Research Program (ERP) Manager,
Location: Santa Monica, CA – Remote
Duration: 12 months
Pay rate: $70/hr - $85/hr on W2
Description:
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 Kite & Gilead 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
To know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/
Should you have any questions, feel free to call me on (415) 322-5419 or send an email on akarsh.yathiraj@leadstackinc.com
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Job Title: Sr External Research Program (ERP) Manager,
Location: Santa Monica, CA – Remote
Duration: 12 months
Pay rate: $70/hr - $85/hr on W2
Description:
- 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 Kite & Gilead 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
To know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/
Should you have any questions, feel free to call me on (415) 322-5419 or send an email on akarsh.yathiraj@leadstackinc.com
| Thanks and Regards Akarsh Yathiraj |
| Senior Recruiter |
| C. | (415) 322-5419 | |
| D. | (415) 322-5419 | |
| A. | 611 Gateway Blvd, Ste 120 South San Francisco, CA 94080 | |
| W. | www.leadstackinc.com | |
Source : Leadstack Inc
