Clinical Project Manager

RBW Consulting

España

On-site

EUR 70,000 - 80,000

Full time

46 hours ago
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Job summary

RBW Consulting in Madrid seeks a Clinical Project Manager to oversee clinical trials for a mid-sized CRO partner. You will lead cross-functional teams, ensure timelines and budgets are met, and maintain regulatory compliance (GCP/ICH).

The ideal candidate has at least 2 years of Clinical Project Management experience in a CRO, with a preference for those based in Madrid or Greater Madrid and willing to work from the office.

Qualifications

  • At least 2 years of Clinical Project Management experience within a CRO environment.

Responsibilities

  • Lead cross-functional study teams and external vendors to deliver clinical projects on time and within quality standards.
  • Manage complex, large-scale, global clinical studies and programmes.
  • Serve as the primary client contact, ensuring clear communication and documentation throughout the project lifecycle.
  • Develop and maintain project management plans and essential study documentation.
  • Review and quality check project deliverables before client submission.
  • Oversee vendor selection, qualification, contracting, and ongoing oversight.
  • Manage timelines, milestones, scope, and budget to ensure successful execution.
  • Monitor performance metrics, identify risks, and implement corrective actions.
  • Oversee TMF activities and regulatory document collection.
  • Coordinate resource allocation and staffing plans; forecast requirements.
  • Monitor study budgets and financial performance to achieve profitability.
  • Lead project handovers and provide matrix leadership to team members.
  • Escalate significant issues and work with leadership on solutions.
  • Prepare and present project status updates and governance reviews.
  • Contribute to business development activities, including proposals and client presentations.

Job description

Clinical Project Manager - mid-sized CRO - €70,000-€80,000 - preference for candidates in the Madrid or Greater Madrid area

Our CRO partner

Our CRO partner is a well-established global, mid-sized Contract Research Organisation (CRO) that partners with biotechnology, pharmaceutical, and medical device companies to support the successful development of innovative therapies from early-phase research through to commercialisation. With operations spanning North America, Europe, and Asia, they have built a reputation for delivering high-quality clinical development services, regulatory expertise, and tailored solutions that help sponsors navigate increasingly complex development programmes.

The organisation offers expertise across a broad range of therapeutic areas, with particular strength in oncology, neurology and psychiatry, immunology, vaccines, endocrinology and metabolic disorders. They also have significant experience supporting rare disease, paediatric, and biosimilar development programmes, making them a trusted partner for sponsors developing therapies in both common and highly specialised indications.

Combining global reach with a collaborative, customer-focused approach, they provide employees with the opportunity to work on cutting-edge clinical research programmes that have a meaningful impact on patient outcomes worldwide.

The Role

The Project Manager fulfils the requirements of managing clinical trials to ensure timely delivery of project required objectives and adherence to timelines within the budget parameters and the client agreements for assigned projects. In doing so, the PM is responsible for the cross functional team’s compliance with the project SOPs, GCP/ICH guidelines and other applicable regulations.

The PM is the point of contact with the client, responsible for the leadership of the project team to execute the contract on time and within budget meeting quality standards. The PM leads and supports the functional areas contracted to ensure effective and timely communication of project progress, identification of issues and plans for resolution and/or management of those issues. The PM maintains focus upon the overall health and satisfaction of the project team to promote successful working relationships. The PM will reports to the Director of Project Management for the Western Region.

The ideal profile will have at least 2 years of Clinical Project Management experience within a CRO environment. The preference is for candidates based in the Madrid or Greater Madrid area as our CRO partner have an office in Madrid which you may be required to occasionally work out of.

Key Responsibilities
  • Lead cross-functional study teams and external vendors to deliver clinical projects in line with timelines, quality standards, GCP, regulatory requirements, and client expectations.
  • Manage complex, large-scale, and global clinical studies and programmes.
  • Serve as the primary point of contact for clients, ensuring clear communication, stakeholder alignment, and comprehensive documentation throughout the project lifecycle.
  • Develop and maintain project management plans and essential study documentation.
  • Review and quality check project deliverables before client submission.
  • Support vendor selection, qualification, contracting, and ongoing oversight in accordance with established procedures.
  • Manage project timelines, milestones, deliverables, and scope to ensure successful execution.
  • Monitor project performance metrics, identify risks, and implement corrective actions to maintain project objectives.
  • Oversee regulatory document collection and submission activities.
  • Ensure Trial Master File (TMF) activities are maintained to inspection-ready standards and appropriately documented.
  • Manage projects in line with contractual requirements, including budget oversight, profitability, change order management, and scope adjustments.
  • Forecast project resource requirements and adjust staffing plans based on evolving study needs.
  • Coordinate resource allocation with functional leaders to support project delivery.
  • Monitor study budgets, expenses, and financial performance to achieve revenue and profitability targets.
  • Oversee site contracting and budget negotiations to ensure delivery within agreed timelines and cost parameters.
  • Manage contractor activity and utilisation against Statements of Work, where applicable.
  • Lead project-specific training initiatives and ensure all required training records are maintained.
  • Support succession planning and ensure effective project handovers when team changes occur.
  • Provide matrix leadership to project team members and contribute performance feedback to line managers.
  • Escalate significant project issues and collaborate with senior leadership to identify and implement solutions.
  • Prepare and present project status updates and governance reviews to internal stakeholders.
  • Contribute to business development activities, including proposals, RFI responses, bid defence meetings, and client presentations.
  • Maintain a strong understanding of applicable quality standards, SOPs, and regulatory guidance to ensure compliance across all project activities.
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