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Research Project Manager

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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 / Research Program 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 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 [email protected]