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Regulatory Submission Project Manager - sponsor dedicated

Employer
Fortrea
Location
Athens, Greece
Salary
Competitive
Start date
23 May 2024
Closing date
22 Jun 2024

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Discipline
Regulatory Affairs, Project Management
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

As Regulatory Submission Project Manager, you are central to the successful start of clinical trials for new compounds in Greece. Not only will this position allow you to stay up to date with the latest scientific breakthroughs across a wide variety of therapeutic areas while collaborating directly with one of our most important sponsors - your work has a genuine impact on improving the health and lives of thousands of patients every day.

If you are an experienced clinical research professional looking for an opportunity to take on more responsibility, hone your leadership skills and significantly raise your profile within the pharmaceutical industry while leveraging your expertise around clinical study start-up processes, this position in Flexible Solutions (FSPx) business unit is a great opportunity!

Your responsibilities:
  • Execute and oversee country submissions and approvals
  • Collaborate with Institutional Review Boards (IRBs), Independent Ethics Committees (IECs) and other regulatory authorities
  • Own both country and site budgets, negotiate and close Clinical Trial Research Agreements, oversee payments and ensure accurate data in our financial systems
  • Manage and coordinate local processes such as clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, data management, documentation requirements, insurance process management and data quality
  • Contribute to the development of local materials and best practices
  • Collaborate closely with other internal and sponsor departments to ensure all country deliverables are met and aligned with global timelines


Education:
  • Degree in a relevant field such as life sciences, biology, biochemistry, chemistry, health care (management), nursing, pharmacology, medicine etc.
  • In lieu of the above, a completed vocational education in the health / life sciences industry and/or equivalent professional experience (e.g. as study nurse, research nurse, study coordinator...)


Experience:
  • Solid professional experience in clinical trials within a CRO or a pharmaceutical company with a focus on study start-up processes
  • Demonstrated experience collaborating with the Greek regulatory authorities and local Ethics Committees - observing all local regulations and guidelines as well as international standards such as ICH and GCP - is required
  • Experience with EUCTR process will be an asset
  • eTMF management
  • Professional experience managing financial aspects of clinical trials considered a definite plus
  • Leadership skills demonstrated by coaching, mentoring and coordinating (project) teams locally and/or virtually
  • Autonomous work style with excellent time and project management skills
  • Ability to build trustful, sustainable relationships with a wide variety of stakeholders based on your outstanding listening and communication skills
  • Business fluency in Greek and English - both spoken and written - is a must

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

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