Executive Director

2 tygodni temu

Warsaw, Polska Pharmiweb Pełny etat
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.

Are you ready to redefine what’s possible, and discover your extraordinary potential at Fortrea?

Fortrea is seeking an experienced and dynamic Executive Director, Clinical Technology Platforms to lead technology initiatives for our clinical operations, clinical pharmacology, and quality organizations. Reporting directly to Vice President, Clinical Platforms, this role will oversee the strategic direction and operational execution of clinical technology programs and product portfolios, ensuring alignment with organizational goals and objectives.

As a key leader, you will lead the charge in transforming trial operations through innovative technology, ensuring compliance with regulatory standards while driving efficiency, elevating quality, and embracing digital-first methodologies. With a deep understanding of both established and emerging technologies, spearhead the advancement of trial execution methodologies to deliver impactful results.

Fortrea is a company dedicated to the idea that people at all levels of our organization should reflect the communities we serve. Diversity, equity, inclusion, and belonging are more than just concepts; they are woven into our DNA. We believe in cultivating a workspace where all employees can thrive.

Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.

Responsibilities include, but are not limited to:
  • Develop and implement strategic plans for several of our operational areas in collaboration with cross-functional teams and external partners
  • Engage in comprehensive oversight of product development for Clinical Operations, Clinical Pharmacology, and our Quality organizations
  • Drive new solutions for site visits, clinical monitoring, risk management and provide our clinical operations colleagues with innovative ways to make a broader impact on the lives of the patients we serve
  • Assume accountability for leading product directors and product managers, each tasked with a suite of technologies
  • Oversee the management, and performance of platform vendors including contract negotiation and service level agreement (SLA) compliance
  • Plan, execute, and monitor Clinical Pharmacology technology projects
  • Ensure adherence to product lifecycle management principles, establish roadmaps, drive functionality enhancements, and meet project timelines
  • Support the execution of clinical study protocols through innovation while ensuring compliance with regulatory requirements and industry standards
  • Manage, implement, and develop solutions in site start-up, study recruitment/conduct, and quality management processes across multiple clinical technology programs
  • Collaborate and partner with internal stakeholders within Clinical Platforms, Clinical Outsourcing, Program Management, R&D, Manufacturing, Regulatory Affairs, and Quality Assurance, to align and integrate clinical operations activities
  • Provide leadership and mentorship to the clinical technology operations team, promoting a culture of excellence, collaboration, and continuous improvement
  • Drive the adoption of best practices and innovative approaches to optimize clinical trial processes and enhance efficiency and effectiveness


Qualifications:
  • Bachelor’s degree in the life sciences, information technology, or related field.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.


Experience:
  • Experienced in clinical operations management within the Clinical Research or pharmaceutical industry required
  • Experience in a leadership role required
  • Familiarity with both Functional Service Provider (FSP) and Full-Service Models, along with proficiency in navigating the clinical trial lifecycle and adhering to 21-CFR Part 11 regulations and validation processes
  • Experience with Phase 1 clinical environments
  • Well-versed in the utilization of common tools and technologies within clinical trials, including TMF, CTMS, DCT, and eSource, EDC, etc
  • Strong understanding of regulatory requirements and industry standards relevant to clinical research, ensuring compliance throughout all stages of clinical trials
  • Proven leadership and mentorship skills, with the ability to inspire, motivate, and develop a high-performing team
  • Excellent verbal and written communication skills, with the ability to effectively communicate complex information to diverse stakeholders and present strategic plans and progress reports to executive leadership
  • Ability to thrive in a fast-paced and dynamic environment, managing multiple priorities effectively and adapting to changing circumstances
  • Demonstrated ability to drive the adoption of best practices and innovative approaches to clinical trial management, leveraging technology and industry trends to optimize processes and enhance effectiveness
  • Strong focus on achieving results and delivering high-quality clinical programs that contribute to advancing healthcare and improving patient outcomes


Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale.

For more information about Fortrea, visit www.fortrea.com.

The application deadline is April 30th, 2024.

#LI-Remote

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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