Clinical Project Manager

Curavit; United States; A distancia; USD 100.000 - 140.000; Jornada completa

Descripción de la vacante

Curavit Clinical Research seeks a full-time Clinical Project Manager to lead cross-functional teams across study startup, execution, and close-out. You will own client relationships, contracts, and project financials, ensuring delivery on time and within budget.

The role emphasizes coordination with the CTM, Stakeholders, and vendors, managing scope, timelines, and budgets while maintaining compliance with ICH-GCP and applicable requirements. Remote US/UK work with US business hours is expected.

Formación

• Bachelor's degree in life sciences, healthcare, business, project management, or a related field.
• Minimum of five years of clinical research or clinical trial operations experience, including responsibility for managing cross-functional study activities.
• Proven experience serving as the single point of contact for Sponsors or clients, with ownership of the overall client relationship from contract award through close-out.
• Strong financial-management, organizational, analytical, negotiation, decision-making, and problem-solving skills.

Responsabilidades

• Client Relationship Ownership: act as the point of contact for client services from contract award through study close-out.
• Contract and Financial Management: own the study contract, budget, change orders, and invoicing.
• Project Planning and Scope: define scope, deliverables, and milestones for continued study objectives.
• Proactive Study Management: oversee study design, schedule, and budget with the CTM and other stakeholders.
• Risk and Change Management: assess risks, develop mitigation, and escalate to senior leaders when appropriate.
• Stakeholder Communication: maintain ongoing communications with internal and external stakeholders and coordinate inputs.

Conocimientos

Client relationship ownership

Budget management

Cross-functional leadership

Stakeholder communication

Project management

Change management

Educación

Bachelor's degree in life sciences

PMP certification (preferred)

Descripción del empleo

Curavit Clinical Research is currently seeking a full-time Clinical Project Manager. The Clinical Project Manager (CPM) is accountable for all phases of the project management process, from study startup and initiation through steady-state transition and closure. The CPM is the single point of contact for the client and owns the overall client relationship, the contract, and project financials. The role leads cross-functional teams to deliver technical systems and operational processes that meet Sponsor and/or CRO study expectations, on time and within budget. As the key liaison between all study stakeholders, the CPM has a significant focus on the implementation phase of clinical research projects, combining project management, business analysis, clinical operations, and commercial management skills.

Primary Responsibilities

• Client Relationship Ownership
• Serve as the point of contact for client services, owning the relationship from contract award through study close-out.
• Build and maintain trusted, long-term client relationships. Understand client priorities and represent them internally while protecting company interests.
• Lead regular client governance meetings, status reporting, and escalation discussions.
• Manage difficult conversations with the client, including scope disputes, delays, and requests that fall outside the contract, with professionalism and transparency.
• Monitor client satisfaction and proactively address concerns before they escalated.
• Identify opportunities for additional scope or future work and partner with Solutions where appropriate.
• Contract and Financial Management
• Own the study contract, including the MSA, work orders, and budget. Ensure that all delivered work aligns with contracted scope and terms.
• Identify out-of-scope requests. Initiate, negotiate, and execute change orders in a timely manner.
• Own project financials, including budget tracking, revenue recognition inputs, forecasting, and margin management.
• Review and approve invoices, pass-through costs, and vendor spend. Ensure accurate and timely client billing against milestones.
• Report on project financial health to leadership, flagging budget variances, risks to margin, and recovery plans.
• Partner with Solutions, Finance and Legal on contract amendments, payment issues, and financial close-out.
• Project Planning and Scope
• Manage the simultaneous implementation of multiple, parallel clinical trial builds using formal project planning techniques.
• Define project scope, deliverables, and milestones in support of study objectives and contracted terms.
• Proactive Study Management
• Hold overall accountability for study delivery, overseeing study design, schedule, and budget.
• Partner closely with the Clinical Trial Manager (CTM), who leads day-to-day clinical operations execution. Align on priorities, timelines, resourcing, and issue resolution.
• Set and continuously manage client and stakeholder expectations, incorporating operational updates and input from the CTM.
• Communicate and collaborate with operational, clinical, and technical stakeholders to assess study design and technology, ensuring that study requirements and regulatory expectations are met.
• Collaborate with the CTM, other departments, and vendors to ensure resources supporting the study are allocated on time and within budget.
• Facilitate clinical trial systems design, review, and testing sessions with internal and external partners.
• Lead learning reviews and drive post-launch performance reviews.
• Oversee study close-out in partnership with the CTM. The CPM owns final client reporting, contract close-out, and financial reconciliation, and the CTM leads operational close-out activities.
• Risk and Change Management
• Assess and manage the impact of risks, issues, and change requests on study design, schedule, budget, and contract.
• Develop mitigation recommendations and elevate to Senior Leaders and/or the Steering Committee when appropriate.
• Maintain clinical trial systems and documentation, and manage change requests through to formal change orders where scope or budget is affected.
• Identify and resolve issues and conflicts within the study team.
• Dependency and Critical Path Management
• Identify and manage study dependencies and critical paths.
• Stakeholder Communication
• Develop and maintain ongoing communications with internal and external stakeholders.
• Act as the single voice to the client. Coordinate input from functional leads so the client receives consistent, aligned communication.
• Document Management
• Communicate and collaborate with the CTM, clinical operations, and training stakeholders to ensure technical solutions and operational processes are well documented and understood.
• Provide oversight of study documentation and operational assets (OPAs), partnering with the CTM to ensure they are developed, maintained, and inspection-ready in the TMF and/or ISF.
• Own the maintenance of project management, contractual, and financial documentation, including the project plan, change orders, and budget records.

Knowledge, Qualifications, and Skills

• Bachelor's degree in life sciences, healthcare, business, project management, or a related field. An equivalent combination of education and relevant experience may be considered.
• Minimum of five years of clinical research or clinical trial operations experience, including responsibility for managing cross-functional study activities.
• Demonstrated understanding of the end-to-end clinical trial lifecycle, including start-up, conduct, data management, and close-out.
• Proven experience serving as the single point of contact for Sponsors or clients, with ownership of the overall client relationship from contract award through close-out.
• Demonstrated ability to build trusted client relationships while protecting company interests, including managing escalations, scope disputes, and out-of-scope requests.
• Experience owning study contracts, including MSAs, work orders, and statements of work, and ensuring delivery aligns with contracted scope and terms.
• Experience identifying out-of-scope work and initiating, negotiating, and executing change orders.
• Experience owning project financials, including budgets, forecasts, invoicing, pass-through costs, vendor spend, and margin management.
• Experience managing study timelines, vendors, and resources across multiple concurrent studies.
• Experience coordinating decentralized, hybrid, virtual, and/or traditional site-based studies is preferred.
• Experience working with globally distributed Sponsors, study teams, sites, and vendors.
• Strong working knowledge of ICH-GCP and applicable local and international clinical research requirements.
• Knowledge of European clinical research and data-privacy requirements is preferred.
• Ability to lead cross-functional teams and influence stakeholders without direct reporting authority, coordinating functional input so the client receives consistent, aligned communication.
• Strong commercial acumen, with the ability to recognize opportunities for additional scope and partner with Business Development, Solutions, and Senior Leadership where appropriate.
• Strong financial-management, organizational, analytical, negotiation, decision-making, and problem-solving skills.
• Excellent written and verbal communication skills, including confidence leading client governance meetings and difficult conversations.
• Professional fluency in written and spoken English is required. Proficiency in an additional language is an advantage.
• Ability and willingness to consistently work US business hours, with flexibility for meetings involving other global time zones.
• Ability to work independently and communicate proactively in a fully remote environment.
• Project Management Professional (PMP) certification or another recognized project-management qualification is preferred.
• Proficiency with project-management tools, clinical trial systems, and collaboration platforms.

Location:

Remote - US or UK

Employment Type:

Full Time

Working Schedule:

Ability to work primarily during US Eastern business hours, with regular flexibility to start early for meetings scheduled during European business hours.

Equal Opportunity Statement

Curavit Clinical Research is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.