Associate Project Manager, Early Phase (Spain)

BlueSnap, Inc; Salamanca; Presencial; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

A leading clinical research organization seeks an Associate Project Manager for Early Phase projects in Spain. The role involves overseeing clinical trials, managing regulatory compliance, and collaborating with various stakeholders. Ideal candidates will have significant industry experience and strong interpersonal skills within a dynamic environment.

Formación

• Minimum 3 years industry experience in pharma, biotech, or CRO.
• At least 2 years in clinical trial management.
• At least 1 year in early phase studies.

Responsabilidades

• Manages operational aspects of clinical projects, ensuring compliance with budgets and timelines.
• Acts as primary contact for stakeholders and coordinates project teams.
• Oversees patient recruitment and regulatory submissions.

Conocimientos

Relationship Skills

Problem Solving

Detail-oriented

Adaptability

Educación

B.Sc. in a related field

Herramientas

Microsoft Office

Descripción del empleo

Associate Project Manager, Early Phase (Spain)

• CRO - Project Management
• Spain
• Professional
• Permanent

Description

The Associate Project Manager, Early Phase and Translational Research (APM, EPTR) ensures the successful initiation, planning, execution, monitoring, controlling, and closure of assigned Early Phase clinical research projects. They are responsible for operational management and oversight of clinical investigative sites and monitoring deliverables, ensuring compliance with budgets, scope, timelines, SOPs, GCP, regulatory, and study-specific requirements. This role operates under close supervision by senior management.

Responsibilities

The Associate Project Manager, EPTR :

• Serves as primary contact for sponsors, sites, CRAs, vendors, and internal teams; may lead projects.
• Coordinates tasks and deadlines across departments.
• Oversees project teams to prioritize site activation activities.
• Coordinates vendor supplies and services with site timelines.
• Escalates risks to project managers.
• Manages sponsor and stakeholder expectations.
• Plans activities and resources.
• Manages quality of work and deliverables.
• Ensures tasks adhere to budgets, scope, timelines, SOPs, GCP, and regulations.
• Reconciles study trackers and analyzes discrepancies.
• Implements corrective actions, change control, and risk management.
• Prepares operational plans and documents.
• Oversees site selection and monitors patient recruitment.
• Participates in Investigator’s Meetings and regulatory submissions.
• Manages essential documents and site documentation.
• Supports quality reviews and audits.
• Supports clinical monitoring activities and serves as a contact for CRAs.
• Tracks site visits, training, and compliance.
• Maintains training matrices and site materials.
• Collaborates with Data Management on CRF and database review.
• Develops trackers and dashboards.
• Provides training and process improvement expertise.

Requirements

Profile :

• B.Sc. in a related field.
• Minimum 3 years industry experience in pharma, biotech, or CRO.
• At least 2 years in clinical trial management.
• At least 1 year in early phase studies.
• Knowledge of GCP, ICH, FDA, and Canadian regulations.
• Proficiency in Microsoft Office.
• Bilingual in English and French.
• Team-oriented with strong relationship skills.
• Creative, detail-oriented, adaptable, with good judgment and problem-solving skills.
• Ability to manage multiple projects under pressure.

Our company

The work environment

At Indero, you will work with talented colleagues in a culture valuing collaboration, innovation, reliability, and responsiveness. We offer a stimulating environment and growth opportunities.

About Indero

Indero is a CRO specializing in dermatology and rheumatology, established in 2000, with a reputation for quality. Based in Montreal, we serve North America and Europe.

Indero is committed to equitable treatment and provides accommodations during recruitment for applicants with disabilities. Only applicants with legal eligibility to work in Spain will be considered.

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