Lead Clinical Project Manager

SolCur; Town of Belgium (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

32 days of holiday per year

Flexible working hours

Full electric company car

Job summary

SolCur in Town of Belgium is seeking a Lead Clinical Project Manager to oversee clinical studies, ensuring compliance with regulations and quality standards. This role emphasizes project management skills as you work closely with stakeholders.

The ideal candidate has several years of experience in clinical operations and project management within the pharmaceutical or CRO industries. With a competitive salary package and flexible working conditions, this role is crucial for supporting clinical development objectives.

Qualifications

• Several years of experience in Clinical Operations, Clinical Trial Management, or Project Management.
• Strong understanding of clinical trial processes and ICH-GCP guidelines.
• Demonstrated experience managing CROs and vendors.

Responsibilities

• Lead planning, execution, and oversight of clinical studies.
• Develop and maintain integrated study timelines and project plans.
• Monitor study progress against key milestones and budget.

Skills

Project management

Stakeholder management

Risk management

Communication skills

Team leadership

Education

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, or a related discipline

Job description

The Lead Clinical Project Manager is responsible for the overall planning, execution, management, and delivery of clinical studies within a clinical development program. This role provides operational leadership throughout the study lifecycle and ensures that clinical trials are conducted in accordance with regulatory requirements, quality standards, timelines, and budget expectations. Working closely with internal stakeholders and external partners, the Lead Clinical Project Manager drives cross-functional collaboration, oversees study progress, and proactively manages risks to support the successful achievement of clinical development objectives.

Scope and responsibilities

• Lead the operational planning, execution, and oversight of one or more clinical studies from start-up through close-out.
• Develop and maintain integrated study timelines, project plans, and study-level operational strategies.
• Ensure studies are conducted in compliance with applicable regulations, ICH‑GCP guidelines, protocol requirements, and company procedures.
• Chair cross-functional study team meetings and coordinate activities across Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Pharmacovigilance, and other key functions.
• Monitor study progress against key milestones, deliverables, timelines, budget, and quality objectives.
• Identify, assess, and proactively manage study risks, issues, and dependencies, ensuring appropriate mitigation and escalation when required.
• Oversee and manage the performance of CROs, vendors, central laboratories, and other external service providers.
• Review study metrics and operational data to support informed decision-making and optimize study execution.
• Support study start‑up activities, including feasibility assessments, country and site selection, enrollment planning, and vendor engagement.
• Ensure effective communication and alignment among all internal and external stakeholders throughout the study lifecycle.
• Lead study governance activities and provide regular project status updates to senior management and program teams.
• Manage study budgets, forecasts, and resource requirements in collaboration with relevant stakeholders.
• Contribute to the development and review of study-related documentation, including operational plans, study manuals, vendor scopes of work, and project reports.
• Support inspection readiness activities and participate in audits and regulatory inspections as required.
• Drive issue resolution and facilitate cross-functional decision-making to maintain study momentum.
• Ensure lessons learned are documented and incorporated into future studies and processes.
• Contribute to continuous improvement initiatives aimed at enhancing study execution, quality, and operational efficiency.

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, or a related discipline.
• Several years of experience in Clinical Operations, Clinical Trial Management, or Project Management within the pharmaceutical, biotechnology, or CRO industry.
• Experience managing global and/or regional clinical trials across multiple countries and sites.
• Strong understanding of clinical trial processes, ICH‑GCP, and applicable regulatory requirements.
• Demonstrated experience managing CROs and external vendors.
• Excellent project management, organizational, and stakeholder management skills.
• Strong ability to lead cross‑functional teams and influence without direct authority.
• Effective problem‑solving, risk management, and decision‑making capabilities.
• Excellent written and verbal communication skills in English.

What we offer:

• We offer a competitive salary package with extra‑legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers, eco vouchers, mobile phone (data included)
• We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, …)
• Side activities will be organised regularly, to achieve a close collaboration within our team
• We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
• We contribute to a number of charities & support the research and / or the patients in our industry.