Senior Project Manager

Indero (formerly Innovaderm); Sevilla; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company in clinical research is seeking a Senior Project Manager to oversee clinical trials. The role involves managing project phases, ensuring quality, and leading project teams. Ideal candidates have extensive experience in clinical project management and thrive in a dynamic environment.

Formación

• At least 10 years of industry experience, including a minimum of 3 years in a CRO.
• At least 7 years of clinical project management experience.

Responsabilidades

• Serve as the primary contact for the Sponsor and provide updates on trial progress.
• Control project budgets and manage operational aspects, including timelines and resources.

Conocimientos

Leadership

Problem Solving

Fluency in English

Educación

B.Sc. in a relevant field

PMP certification

Herramientas

Microsoft Office

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Senior Project Managers are crucial to the success of clinical trials managed by Indero. They serve as the main point of contact internally and externally, ensuring all activities and deliverables are completed on time, within budget, and to expectations.

Great project managers go beyond creating project plans and following up on tasks. They demonstrate leadership to help project teams focus on objectives and deliver results.

This role is ideal for you if :

• You have at least 7 years of global clinical project management experience, including managing all project phases from start-up to closure, overseeing functional services, and vendor management, including experience in European regions.
• You want to work for a mid-sized CRO involved in significant multisite trials, including global Phase III projects.
• You seek an environment where you can grow your career alongside the company.

Impact and Responsibilities

Client interactions

• Serve as the primary contact for the Sponsor.
• Provide efficient and timely updates on trial progress.

Project planning

• Oversee and participate in preparing project deliverables such as study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports.
• Participate in planning and conducting Investigator’s Meetings.
• Ensure sites have necessary materials (investigational products, supplies, equipment, safety labs, etc.).

Quality and risk management

• Maintain studies as “audit ready” at all times.
• Monitor the quality of study deliverables, including vendor and SubCRO outputs, and address issues promptly.
• Manage risk and implement control measures to ensure project quality.
• Analyze discrepancies between planned and actual results.
• Review and approve responses to quality audits.

Project budget and timelines

• Control project budgets, focusing on internal hours and activities.
• Identify out-of-scope activities for change orders.
• Manage operational aspects, including timelines, budgets, resources, and vendors.
• Communicate effectively with team members, departments, and senior management.
• Manage recruitment status and initiate actions to meet recruitment targets.

Project team leadership

• Lead core project teams, including Associate Project Managers, Coordinators, and Assistants.
• Ensure team members are adequately trained.
• Collaborate with vendors and internal teams (Site Selection, Regulatory, Data Management, Monitoring, Biostatistics, Scientific Affairs) to ensure timely completion of tasks and deliverables.

Requirements

Education

• B.Sc. in a relevant field related to clinical research.
• PMP certification is an asset.

Experience

• At least 10 years of industry experience, including a minimum of 3 years in a CRO.
• At least 7 years of clinical project management experience, managing all project phases, functional services, and vendors, including experience with mid-size and large studies (>

10-15 countries) across multiple regions (NA, SA, APAC, MENA, Europe).

• Experience leading multinational Phase III trials with budget tracking and forecasting.
• Additional experience in study startup, regulatory submissions, resource management, supervision, CRA, data management, medical writing, or vendor management is a plus.
• Therapeutic experience in dermatology, oncology, inflammatory bowel diseases, rheumatoid arthritis, or oncology trials is an asset.

Knowledge and Skills

• Excellent knowledge of GCP, ICH standards, FDA, and local regulations.
• Proficiency in Microsoft Office suite.
• Fluency in English, with excellent oral and written skills; bilingualism is a plus.
• Ability to work in a team and establish good relationships with colleagues and sponsors.
• Strong problem-solving skills and ability to manage multiple projects under pressure while meeting deadlines.
• Good understanding of clinical practices, Health Canada, and FDA regulations / guidelines.

Mid-Senior level.

Employment Type

Full-time.

Job Function

Project Management.

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