6 Tide St Boston, MA 02110 US
- The Project Manager is responsible for overseeing IND enabling studies through clinical proof of concept clinical trials. Working with the project lead, S/he ensures the program remains on-time and on-budget with high-quality execution and conduct in compliance with domestic and international regulations.
Some of the responsibilities of this role include but are not limited to:
- Create and maintain integrated clinical development program timelines; awareness and anticipation of interdependencies and resource needs; Track program goals.
- Guide the planning and execution of studies from start to study report while adhering to budget, scope and schedule requirements
- Interface with CROs, CDMOs and other key vendors
- Facilitate and manage productive cross functional program development team meetings (prepare agendas, minutes), ensure progress towards program goals, hold team members accountable for action items and focus to drive critical decision-making.
- Identify critical path activities. Proactively identify risk and document contingency or mitigation plans
- Analyze actual performance against the plan and make adjustments consistent with overall objectives and development strategy.
- Manage program budget and budget projections, vendor purchase orders, and invoices
- Prepare reports, summaries and presentations that provide succinct status updates for ongoing projects and programs.
- 3– 5 years of relevant work experience in the pharmaceutical/biotechnology industry (Sponsor side) with at least 2 years in project management, program planning, and operations
- Functional knowledge of Clinical Development Planning and execution, ICF, GCP and other relevant regulatory/health authority guidelines
- Understanding and familiarity with IND enabling studies
- Experience managing and tracking product and clinical development programs
- Familiarity with regulatory and clinical development landscape
- Proficient program/project management skills and principles, including scope, schedule, resource and risk management.
- Ability to apply a quantitative approach to poorly defined problems
- Pro-active self-starter who will thrive in an entrepreneurial environment
- Excellent communication skills
- Being based in the greater Boston area is preferred but not required
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