Match score not available

Senior Manager External Research Program (ERP)

Remote:

Full Remote

Contract:

Fixed term

Experience:

Expert & Leadership (>10 years)

Work from:

Canada

Offer summary

Qualifications:

Master's with 4+ years experience, Bachelor's with 6+ years experience, Associate with 8+ years experience, High School Diploma with 10+ years experience.

Key responsabilities:

Manage operations for investigator-sponsored and collaborative studies.
Monitor study timelines, metrics, and progress.
Collaborate with internal teams to review protocols and support clinical activities.
Communicate with institutional contacts for compliance and reporting.
Produce monthly reports on ERP portfolio progress.

ICONMA Human Resources, Staffing & Recruiting Large https://www.iconma.com/

1001 - 5000 Employees

See more ICONMA offers

Job description

Senior Manager External Research Program (ERP)

Location: Remote
Duration: 12 Months

Description:
Kite’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 Kite & 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