Sr Manager, External Research Program (ERP) - TekWissen LLC
Santa Monica, CA
About the Job
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Position: Sr Manager, External Research Program (ERP)
Location: Santa Monica, CA 90404
Duration: 12 Months
Job Type: Contract
Work Type: Remote
Job Description:
- 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
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Source : TekWissen LLC
