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Fortrea

9d ago

  • Job
    Full-time
    Mid & Senior Level
  • Research & Development
  • Madrid
  • Quick Apply

AI generated summary

  • You must have a degree or 4-6 years in clinical research, knowledge of ICH/GCP, strong communication skills, and the ability to work independently and in teams.
  • You will manage site budgets, oversee clinical payments, ensure timely submissions and approvals, develop local materials, and collaborate across teams for successful trial execution.

Requirements

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
  • Thorough understanding of the drug development process
  • Fluent in local office language and in English, both written and verbal
  • Good organizational and time management skills
  • Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
  • Excellent communication skills, oral and written.
  • Self-motivation with the ability to work under pressure to meet deadlines. Works well independently and in a team environment.
  • Detail and process oriented
  • Positive attitude and approach
  • Interact with internal and external customers with a high degree of professionalism and discretion.
  • Multi-tasking capability.
  • Good computer skills with good working knowledge of a range of computer packages
  • Ability to lead and develop junior staff.
  • Flexible and adaptable to a developing work environment
  • Minimum of four-six (4-6) years of clinical research experience

Responsibilities

  • - Assistance with the ownership of country and site budgets
  • - Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value
  • - Oversight and tracking of clinical research-related payments
  • - Payment reconciliation at study close-out
  • - Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols
  • - Development of local language materials including local language Informed Consents and translations
  • - Works in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols
  • - Responsible for managing country deliverables, timelines, and results for assigned protocols to meet country commitments
  • - Contributes to the development of local SOPs
  • - Works in close collaboration internally with Clinical country operations, Country Quality Manager, Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
  • - Collaborates closely with Regional Operations to align country timelines for assigned protocols
  • - Provides support and oversight to local vendors as applicable
  • - Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management
  • - Enters and updates country information in clinical, regulatory, safety and finance systems
  • - And all other duties as needed or assigned

FAQs

What qualifications are required for the Associate Project Manager position at Fortrea?

A university/college degree in a life science or certification in a related allied health profession is preferred, or relevant experience in lieu of educational requirements. Candidates with at least four years of relevant clinical research experience in the pharmaceutical or CRO industries will also be considered.

How many years of clinical research experience are needed for this role?

A minimum of four to six years of clinical research experience is required.

What language skills are necessary for this position?

Fluency in the local office language and in English, both written and verbal, is required.

What type of experience is preferred regarding regulatory requirements and guidelines?

Familiarity with ICH, FDA, local regulatory requirements, IRB/IEC, and experience with investigator start-up documents is preferred.

Is previous clinical trial experience necessary?

Yes, previous clinical research experience, especially in pharmaceutical or CRO industries, is preferred.

What are the key responsibilities of the Associate Project Manager?

Key responsibilities include managing country deliverables and timelines for clinical trial activities, overseeing financial contracts and budgets, executing country submissions and approvals, and collaborating with various internal and external stakeholders.

What skills are required to succeed in this role?

Good organizational and time management skills, excellent communication abilities, self-motivation, attention to detail, the ability to work under pressure, and multi-tasking capabilities are essential.

Is Fortrea committed to diversity and inclusion?

Yes, Fortrea is committed to diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

Will Fortrea provide training or support for junior staff in this role?

Yes, the role may involve leading and developing junior staff.

What is the work environment like at Fortrea?

Fortrea fosters a collaborative workspace where personal growth is nurtured, and employees are encouraged to make a meaningful global impact.

Fortrea

Science & Healthcare
Industry
10,001+
Employees
2023
Founded Year

Mission & Purpose

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.