Clinical Project Manager

Stealth Mode Biotech; Massachusetts; Hybrid; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

Stealth Mode Biotech in the Boston area seeks a proactive Clinical Project Manager to plan, coordinate, and execute early-phase clinical trials from startup to closeout. You will partner with internal teams, CROs, sites, and vendors to keep timelines, milestones, and budgets aligned with GCP and regulatory requirements.

The role requires 10+ years in clinical operations, proven experience with study startup, enrollment acceleration, and vendor oversight in a lean biotech setting.

Qualifikationen

• 10+ years in clinical operations, clinical study management, or clinical project management within biotech/pharma
• Experience with early-phase trials (Phase I/II) and aggressive enrollment targets
• Experience overseeing CROs and external vendors with deliverable accountability

Aufgaben

• Clinical Trial Planning and Execution from startup through closeout
• Site activation, enrollment planning, and feasibility assessments
• CRO/vendor selection, oversight, and issue resolution
• Timeline, milestone, and budget management across functions
• Cross-functional coordination with Regulatory, Data Management, Biostatistics, Safety, Medical, Quality
• External partner coordination with imaging and central laboratory vendors
• Risk and issue management with mitigation planning
• Regular status reporting and stakeholder communication
• Study closeout activities and archival documentation

Kenntnisse

Program management

Cross-functional leadership

Vendor management

GCP compliance

Ausbildung

Bachelors degree in life sciences or related field

Advanced degree preferred

Jobbeschreibung

The Clinical Project Manager (CPM) is responsible for the planning, coordination, and execution of clinical trials from study startup through closeout. Working closely with internal stakeholders, CROs, clinical sites, and specialized vendors, the CPM will drive study timelines, manage operational risks, and ensure milestones are achieved efficiently and in compliance with GCP and applicable regulatory requirements.

This role is particularly important to the successful launch and execution of an early-phase clinical study with an aggressive enrollment timeline. The ideal candidate is a proactive, hands-on project manager who can effectively oversee CROs and external partners, hold teams accountable for deliverables, and maintain strong internal oversight in a lean, fast-paced biotech environment.

Key Responsibilities

• Clinical Trial Planning and Execution: Develop and implement study plans. Ensure timelines, milestones, and project trackers are maintained and study status is communicated effectively. Drive study activities from startup and site activation through enrollment, study conduct, and closeout according to SOPs, approved timelines, agreed budget, and quality standards.
• Study Startup and Enrollment: Drive feasibility, site selection, and startup activities and site readiness to support rapid study initiation and enrollment. Proactively monitor site activation and recruitment progress, identify bottlenecks, and work with CROs and sites to meet aggressive enrollment targets.
• CRO and Vendor Selection and Oversight: Serve as the internal point of accountability for day-to-day CRO performance and coordination of external vendors. Monitor deliverables, timelines, and quality; lead project meetings; resolve operational issues; and elevate risks and issues as needed.
• Timeline and Milestone Management: Maintain a clear view of critical-path activities, dependencies, and deliverables. Drive follow-through across internal and external teams, anticipate delays, and implement corrective actions to keep the study on track.
• Cross-Functional Coordination: Partner with Clinical Operations, Regulatory, Data Management, Biostatistics, Safety, Medical, Quality, and other relevant functions to coordinate study activities and ensure alignment across workstreams.
• External Partner Coordination: Coordinate specialized service providers, including central imaging and central laboratory vendors, as applicable. Ensure vendor activities are integrated into the overall study plan and managed efficiently.
• Risk and Issue Management: Identify and proactively manage operational risks, maintain risk and issue logs, develop mitigation plans, and elevate issues that could affect study timelines, quality, or budget.
• Budget and Resource Management: Monitor study budgets, forecasts, vendor costs, and invoices. Identify potential cost variances and support efficient use of internal resources and external service providers.
• Data and Study Deliverables: Track key study deliverables and milestones across data management, biostatistics, interim analyses, database lock, clinical study reports, and essential study documentation. Coordinate with relevant functional leads to support timely access to study data and completion of deliverables.
• Quality and Compliance: Ensure study activities are conducted in accordance with GCP, applicable regulations, protocols, and internal procedures. Support audit and inspection readiness, essential document completion, and timely resolution of study-related findings.
• Communication and Reporting: Lead study team and vendor meetings, document decisions and action items, maintain accurate status reports, and communicate progress, risks, dependencies, and next steps to stakeholders.
• Study Closeout: Coordinate final study deliverables, site and vendor closeouts, financial reconciliation, and study documentation and archival activities.

Qualifications & Experience

• Bachelor's degree in life sciences, healthcare, or a related field; advanced degree preferred.
• 10+ years of experience in clinical operations, clinical study management, or clinical project management within the biotechnology or pharmaceutical industry with a minimum 5 years in director-level or associate-director-level clinical project management roles
• Experience working in a lean, resource-conscious biotech environment, ideally within a small biotech that relies on CROs and external vendors while retaining internal oversight and accountability.
• Experience managing early-phase clinical trials, ideally Phase I and/or Phase II studies, with a demonstrated ability to drive study startup, accelerate site activation, and achieve enrollment milestones within aggressive timelines.
• Demonstrated experience overseeing CROs and multiple external vendors, including vendor selection, relationship management, performance monitoring, and accountability for study deliverables.
• Strong project management capabilities, including integrated study planning, feasibility assessment, timeline and critical-path management, budget oversight, resource planning, and risk identification and mitigation.
• Experience with study-level financial planning, budget management, forecasting, and cost oversight.
• Ability to coordinate cross-functional activities across Clinical Operations, Data Management, Biostatistics, Safety, Medical, Regulatory, and other relevant functions.
• Working knowledge of GCP, clinical trial processes, applicable regulatory requirements, and essential study documentation.
• Strong organizational, communication, problem-solving, stakeholder management, and decision-making skills, with the ability to balance strategic planning with hands-on execution.
• Ability to work onsite in the Boston area approximately two days per week and attend key in-person study meetings as needed.