Project Manager II (Spain)

Visa Hunt; España; Presencial; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible work schedule

Permanent full-time position

Company benefits package

Ongoing learning and development

Descripción de la vacante

Indero, a CRO focused on dermatology and rheumatology, seeks a Project Manager II to lead multi-site clinical trials in accordance with GCP/ICH, SOPs and budgets. You will manage timelines, sponsor communications and study deliverables while coordinating cross-functional teams across sites in Europe and North America.

The role requires 5+ years in clinical trial management (Phase I-III) and a strong track record overseeing trials with budgets above $3M USD.

Formación

• B.Sc. in a related field of study to clinical research
• At least 5 years industry experience with a minimum of 3 years in Phase I-III clinical trial project management
• Experience managing dermatology and/or rheumatology trials
• Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD
• Dermatology trial experience is a plus (asset)

Responsabilidades

• Serve as primary contact for Sponsor
• Provide efficient and timely updates on trial progress
• Lead client calls effectively
• Oversee and participate in preparation of deliverables (study plans, protocol, informed consent, eCRF, TLFs, CSR)
• Lead site start-up activities including TMF setup, site activation and budgeting
• Collaborate with Regulatory Affairs to ensure timely submissions and essential documents
• Partner with Data Management to ensure CRF alignment and data review timelines
• Ensure studies are audit-ready and manage risk to maintain quality

Conocimientos

GCP & ICH knowledge

MS Office

English (oral & written)

Communication skills

Team collaboration

Problem solving

Organization

Time management

Educación

B.Sc. in related field

Descripción del empleo

Description

The project manager II has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The project manager II oversees and coordinates study resources to ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. Project Manager II acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline)

This role will be perfect for you if:

• You want to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects
• You are looking to position yourself in an environment where you can grow your career alongside the company

IMPACT AND RESPONSIBILITIES

Client interactions

• Serve as primary contact for the Sponsor
• Provide efficient and timely updates on trial progress
• Lead client calls effectively

Project planning

• Oversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.
• Participate in the planning and conduct of the Investigator’s Meeting.
• Ensure that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).
• Lead study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines, and site contracting and budgeting.
• Collaborate with Regulatory Affairs to ensure timely submissions and completeness of essential documents prior to site initiation and throughout the study.
• Partner with Data Management to ensure CRF alignment with protocol and sponsor requirements, and that data review, query resolution, and database lock timelines are met.

Quality and risk management

• Ensure assigned studies are “audit ready” at all times.
• Monitor the quality of study deliverables, (including vendor and SubCRO deliverables) and address issues as they arise.
• Manage risk and control measures to assure project quality.
• Analyze discrepancies between planned and actual results.

  Project team leadership

  • Lead the core project team which may include: Associate Project Managers, Project Coordinators, Project Assistants.
  • Ensure all team members have adequate training on the project.
  • Work closely with vendors and the following internal teams to ensure all tasks and deliverables are completed on time, according to plans and according to applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs.
  • Define and maintain the project-specific training matrix and ensure training records are kept up to date throughout the study.

  Requirements

  Education

  • B.Sc. in a related field of study to clinical research

  Experience

  • At least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project management
  • Experience managing dermatology and/or rheumatology trials
  • Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD.
  • Experience managing dermatology trials an asset

  Knowledge and skills

  • Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations
  • Excellent knowledge of Microsoft Office suite
  • Excellent oral and written skills in English, French is an asset
  • Excellent communication skills
  • Ability to work in a team environment and establish good relationships with colleagues and sponsors
  • Good problem-solving abilities
  • Good organizational skills
  • Strong ability to carry out different projects and work under pressure while meeting timelines

  Our company

  The work environment

  At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

  In this position, you will be eligible for the following perks:

  • Flexible work schedule
  • Permanent full-time position
  • Company benefits package
  • Ongoing learning and development

  About Indero

  Indero is a CRO specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

  Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

  Indero only accepts applicants who can legally work in Spain.

  Originally posted on Himalayas