Sr. Manager, Clinical Trial Operations Planning & Analytics
BioSpace · Somerset, NJ · 2 wk ago
HybridInformation Technology$127k–$167k/yrFull-time
Key Responsibilities
- Lead development of standardized frameworks, tools, and processes for feasibility, site identification, enrollment forecasting, study startup planning, and predictive trial performance modeling across pipeline studies.
- Develop data-driven approaches to identify the right countries and sites globally to support activation and enrollment acceleration and to predict key operational outcomes such as startup timing, enrollment, and study completion.
- Create scenario models and planning outputs to support base and best case operational strategies and contingency planning.
- Establish contingency planning triggers, risk indicators, and escalation thresholds based on modeled performance risk.
- Partner with study teams, CROs, and cross-functional stakeholders to pressure-test trial assumptions and refine country and site strategies.
- Create and maintain dashboards and analytics to monitor startup, activation, enrollment, and delivery risk trends.
- Translate study and portfolio performance data into actionable insights and executive-ready recommendations for senior leadership.
- Support continuous refresh of assumptions as study conditions, portfolio priorities, and external dynamics evolve.
- Capture lessons learned and convert them into reusable planning tools, templates, and methodologies that improve cross-study consistency.
- Represent the function in internal planning discussions and external partner interactions related to feasibility, forecasting, and performance analytics.
Requirements
- Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific, health care, data, or related discipline. Advanced degree preferred.
- 7+ years of pharmaceutical, biotech, CRO, or related clinical research experience; 10+ years preferred.
- Experience working with data sources to inform trial forecast modeling.
- Experience in clinical operations planning, feasibility, study startup, operational analytics, or related functions required.
- Experience supporting global site identification, country strategy, or enrollment planning strongly preferred.
- Experience building dashboards, models, or analytics to support clinical trial execution preferred.
- Oncology, cell therapy, or early-phase clinical development experience preferred.
- Ability to travel as necessary (approximately 10%).
- Knowledge/familiarity with tools to enable trial forecasting and modeling.
- Strong critical thinking, analytical, strategic planning, and problem-solving skills.
- Effective oral, written, and interpersonal communication skills with strong presentation capability.
- Forward and critical thinker with ability to translate data into decisions.
- Strong organizational and project management skills and the ability to multitask.
- Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project, and analytics/visualization tools).
- Working knowledge of GCP, FDA, and ICH Guidelines.