STUDY MANAGER

SPAULDING CLINICAL RESEARCH LLC•West Bend, WI

1d•$85,000 - $115,000•Onsite

About The Position

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. The position may be filled at the Project Manager or Senior Project Manager level depending on experience, demonstrated competency, study complexity, and business need. Senior Project Managers are expected to manage more complex programs or strategic accounts, operate with greater independence, support escalated issues, contribute to process improvement, and mentor less experienced project delivery staff. This role ensures assigned studies are delivered in accordance with protocol requirements, regulatory expectations, Good Clinical Practice, internal SOPs, contractual commitments, and Spaulding Clinical service standards.

Requirements

Ability to read, write, and interpret the English language.
Knowledge of project management practices and clinical research project delivery.
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.
For Senior Project Manager level, demonstrated ability to manage complex projects independently, support escalations, mentor others, and contribute to process improvement.
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.

Nice To Haves

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.

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.