Note: The job is a remote job and is open to candidates in USA. Spaulding Clinical Research, LLC is a company specializing in clinical research, and they are seeking a Project Manager/Senior Project Manager to oversee client-sponsored clinical research projects. This role involves planning, execution, and delivery of projects while ensuring compliance with regulatory standards and managing relationships with sponsors.
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
- For Senior Project Manager level, independently lead complex, high-priority, multi-stakeholder, or strategic sponsor projects and provide guidance during escalations or transitions
- Serve as the primary client-facing project lead for assigned studies, programs, and sponsor communications
- Build effective relationships with sponsors, vendors, and external partners through clear communication, accountability, responsiveness, and high-quality delivery
- Ensure sponsor expectations, project decisions, risks, action items, assumptions, and scope changes are clearly documented and communicated throughout the project lifecycle
- Prepare and distribute project status updates, meeting agendas, minutes, action trackers, risk summaries, and other project communications as required
- 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, serve as a trusted escalation partner for complex sponsor concerns and support strategic account delivery as assigned
- Support project-level financial performance through awareness of project budget, milestones, pass-through costs, out-of-scope activities, and change order needs
- Partner with Finance, Contracts, Business Development, and operational teams to support appropriate revenue recognition, invoicing inputs, and contract compliance
- 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
- For Senior Project Manager level, provide stronger independent financial oversight for assigned projects and help coach team members on scope and change order management
- Use and maintain project management tools, templates, workflows, KPIs, and governance practices to support consistent project delivery
- Promote effective intra-departmental and cross-functional relationships to support operational alignment, project execution, and sponsor satisfaction
- 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
- For Senior Project Manager level, 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
- Maintain current knowledge of SOPs, Good Clinical Practice, ICH guidelines, applicable laws, regulatory expectations, and ethical standards
- Promote a quality-first approach to study delivery, documentation, communication, and issue escalation
- 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 cross-functional study teams by establishing clear expectations, facilitating accountability, and promoting timely completion of project deliverables
- Demonstrate professionalism, sound judgment, urgency, and effective communication in all interactions with sponsors, vendors, leadership, and internal teams
- Provide informal guidance to project team members on project communications, escalation management, documentation quality, and cross-functional coordination
- 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
- Bachelor's degree in life sciences, healthcare, business, project management, or a related field
- Project Manager: generally, 3 or more years of clinical research, CRO, pharmaceutical, biotechnology, healthcare, or regulated project management experience
- Senior Project Manager: generally, 5 or more years of progressive clinical research project management experience, including independent management of complex or multi-stakeholder studies
- Strong working knowledge of clinical trial operations, ICH-GCP, FDA regulations, sponsor expectations, and CRO service delivery
- Demonstrated experience managing project timelines, risks, scope, deliverables, project communications, and cross-functional stakeholders
- Experience supporting client relationships, project financial awareness, issue escalation, and change order identification
- Excellent communication, problem-solving, negotiation, and organizational skills in a fast-paced regulated environment
- Advanced degree in life sciences, healthcare administration, business, or a related field
- PMP, PgMP, CCRA, CCRP, or other relevant professional certifications
- 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
- Experience supporting bid defenses, sponsor governance meetings, commercial proposals, and change order processes
- Familiarity with CTMS, eTMF, project planning tools, resource management systems, and financial tracking platforms
- Experience building or scaling a project management function within a CRO or clinical research organization
- For Senior Project Manager level, experience mentoring project staff, leading complex sponsor accounts, or supporting development of project management processes and standards
Benefits
- FULLY REMOTE - LESS THAN 10% TRAVEL REQUIRED
Company Overview
Company H1B Sponsorship