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Regulatory Start-up Project Manager - Sponsor-based

Employer
Labcorp
Location
Budapest, Hungary
Salary
Competitive
Start date
8 Sep 2021
Closing date
20 Sep 2021

View more

Discipline
Clinical Research, Study Start Up
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


WHO ARE WE?

As a leading contract research organization (CRO), Labcorp Drug Development (formerly known as Covance) provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

THE JOB

We are recruiting for our FSPx business in Hungary and are currently seeking to hire aStart-up Project Manager with significant focus on regulatory oversight.

This is a sponsor-dedicated, permanent and full-time position, based in Budapest.

Responsibilities:
  • 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 (CRD, CRM,CTC,CRA), Country Quality Manager (CQM), 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
  • 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
Education/Qualifications:
  • 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
  • In lieu of the above requirement, candidates with proven relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered
  • 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 Hungarian and in English, both written and verbal
Experience:
  • 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
  • Self-motivation with the ability to work under pressure to meet deadlines
  • Ability to lead and develop junior staff

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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