Project Manager/Senior Project Manager

Job Summary

The Project Manager / Senior Project Manager is responsible for the successful planning, execution, monitoring, and delivery of client-sponsored clinical research projects. This role serves as the primary operational point of contact for assigned sponsors and internal cross-functional study teams, with accountability for project scope, timelines, budget awareness, risk management, communication, documentation, quality, and sponsor satisfaction.

Essential Duties And Responsibilities

• Manage assigned CRO-sponsored clinical research projects, including phases I/II, clinical pharmacology, cardiac safety, and related study types.

• Develop, maintain, and drive project plans, timelines, milestones, risk logs, actions, decisions and issues logs, communication plans, and study-specific deliverables.

• Coordinate cross-functional activities with Clinical Operations, Data Management, Regulatory, Pharmacy, Laboratory, Biometrics, Finance, Contracts, Quality Assurance, and other departments as required.

• Facilitate project start-up, internal handoffs, study kickoffs, recurring project team meetings, sponsor meetings, and closeout activities.

• Track progress against scope, timelines, deliverables, budget assumptions, and contractual obligations; identify variances and support timely corrective action.

• Proactively identify project risks, issues, dependencies, resource constraints, and operational challenges; escalate appropriately and drive issue resolution.

• Maintain strong working knowledge of Spaulding Clinical Research processes, SOPs, project management practices, internal operational policies, and sponsor delivery expectations.

• Support project-level financial performance through awareness of project budget, milestones, pass-through costs, out-of-scope activities, and change order needs.

• Track scope, assumptions, deliverables, and budget impacts; communicate potential changes or risks to stakeholders in a timely manner.

• Identify out-of-scope work and escalate change order needs according to internal processes.

• Use and maintain project management tools, templates, workflows, KPIs, and governance practices to support consistent project delivery.

• Monitor project performance metrics, including timeline adherence, budget performance, change order management, quality indicators, client satisfaction, and resource utilization as assigned.

• Support continuous improvement initiatives that enhance project predictability, communication, efficiency, documentation quality, and sponsor experience.

• Participate in department meetings, project reviews, and lessons-learned activities; communicate project priorities, updates, decisions, and assigned action items clearly.

• Lead cross-functional study teams by establishing clear expectations, facilitating accountability, and promoting timely completion of project deliverables.

• Provide informal guidance to project team members on project communications, escalation management, documentation quality, and cross-functional coordination.

• Contribute to development or refinement of project management tools, templates, checklists, workflows, training materials, and department standards.

• Ensure project management activities are conducted in compliance with applicable regulations, ICH-GCP, FDA expectations, client requirements, and Spaulding SOPs.

• Partner with Quality Assurance to support CAPAs, audit responses, root cause analysis, process improvements, and inspection-readiness activities when needed.

• Initiate or support Quality Assurance involvement when project issues, clinical practice concerns, audit findings, process gaps, or compliance risks may affect study quality, clinical operations, or participant safety.

• Ensure assigned project documentation is accurate, current, timely, and maintained in applicable systems and study files.

• Lead or support sponsor governance meetings, bid defense preparation, project kickoffs, lessons-learned reviews, and client satisfaction follow-up.

• Respond promptly and professionally to project, departmental, or sponsor concerns; ensure appropriate escalation to management or senior leadership when required.

• Partner with Business Development, Finance, Contracts, and operational teams to support proposals, scope development, change orders, and client retention strategies.

• For Senior Project Manager level, independently lead complex, high-priority, multi-stakeholder, or strategic sponsor projects and provide guidance during escalations or transitions.

• For Senior Project Manager level, serve as a trusted escalation partner for complex sponsor concerns and support strategic account delivery as assigned.

• For Senior Project Manager level, provide stronger independent financial oversight for assigned projects and help coach team members on scope and change order management.

• For Senior Project Manager level, contribute to development or refinement of project management tools, templates, checklists, workflows, training materials, and department standards.

• For Senior Project Manager level, mentor Project Managers, Associate Project Managers, or project support staff; assist with onboarding, training, and development of project management best practices as assigned.

• Foster a culture of accountability, collaboration, continuous improvement, and inspection readiness.

Skills/Qualifications

• Ability to read, write, and interpret the English language.
• Demonstrated ability to manage multiple competing priorities and deliver results according to deadlines.
• Excellent planning, organizational, meeting facilitation, and time management skills.
• Able to utilize data and facts to analyze problems, identify risks, and recommend solutions.
• Strong written and verbal communication skills, including ability to build and maintain effective interpersonal relationships with a variety of personalities.
• Professional presence and ability to communicate effectively with clients and staff in both casual and formal meetings.
• Detail oriented, with ability to produce accurate and timely documents.
• Self-motivated, results oriented, responsive to urgent needs, and able to work under pressure within tight timelines.
• Sound judgment and practical business decision-making.
• Able to influence without direct authority and promote accountability across cross-functional teams.
• Strong computer skills, including Microsoft Word, Excel, and PowerPoint at an intermediate level; inclination to adopt technology to maximize efficiency.
• Advanced degree in life sciences, healthcare administration, business, or a related field (preferred).
• PMP, PgMP, CCRA, CCRP, or other relevant professional certifications (preferred).
• Experience in early and late-phase clinical research, Phase I units, multi-site trials, cardiac safety, thorough QT studies, clinical pharmacology, or specialty CRO services (preferred).
• Experience supporting bid defenses, sponsor governance meetings, commercial proposals, and change order processes (preferred).
• Familiarity with CTMS, eTMF, project planning tools, resource management systems, and financial tracking platforms (preferred).
• Experience building or scaling a project management function within a CRO or clinical research organization (preferred).
• Experience mentoring project staff, leading complex sponsor accounts, or supporting development of project management processes and standards (preferred).