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Senior Clinical Feasibility Leader
PAREXEL International Corporation
Own the challenges that lead to innovation and growth
Promoted to Head of Biotech Operations for Americas East, helping clients develop novel therapies with a focus on patient needs.
Advanced to Corporate VP Clinical Operations to lead Site Monitoring for Americas, Europe and SE Asia.
Streamlined Parexel’s clinical operations model; driving effectiveness, and increasing employee, client and site satisfaction.
Promoted to VP Clinical Operations, and relocated to the US in 2017.
Promoted to Senior Director of Clinical Operations for the Americas, consolidating both North and South American regions.
Joined Parexel as Director of Global Monitoring Operations for Latin America.
Create the solutions that drive global projects to success
Promoted to Senior Director, Project Management. Taking on management responsibilities for dedicated Enterprise accounts and enhancing his contributions to Parexel’s Global Project Leadership.
Managing Project Director role for dual Enterprise accounts, with a focus on client delivery and satisfaction in order to bring in new awards and expand growth.
Assumed the role of Global Project Leadership Training Coordinator, ensuring new PLs are properly inducted in all regions, while leading cross regional meetings to review and update training materials for PLs.
Promoted to Associate Director in Project Management at Parexel working on post-approval smoking cessation treatment.
Joined Parexel as a Senior Project Lead mentoring and managing 5 project managers working on a phase IV smoking cessation treatment.
Be part of a diverse team that drives healthcare innovation
Advanced into Senior Manager, Human Resources
Promoted to Manager, Human Resources Operations
Joined Parexel as a Human Resources Operations Partner.
Human Resources Business Partner at leading pharmaceutical company.
Manager of Diversity Resources.
Contribute to meaningful advances that benefit patients in need
Joined the Scientific Data Organization as Scientific Data Technology Director, creating agile access to real world data, bringing best in class technology solutions to Parexel services, and harnessing data to transform therapy development for patients.
Promoted to Director IT Project and Programme Office, leading engineering projects for Wearable and Sensor devices with a view to streamlining Clinical Trials patient engagement and approaches.
Promoted to Associate Director of IT Program and Project Management at Parexel.
Joined Parexel as a Project Manager in the IT Project Program Office.
Own the challenges that make you grow
Promoted to Senior Medical Writer, focusing on the development and support of clinical documents intended for regulatory submission.
Began a new role working remotely as a Medical Writer II, researching and coordinating the development of clinical documents intended for submission to the FDA or other regulatory authorities.
Director of Imaging Operations leading a team of 13 Project Managers and the imaging of over 130 clinical trials.
Senior Project Manager, overseeing standardization of program operations and deliverables while leading a team of Project and Imaging Research Managers.
Promoted to Project Manager for clinical oncology trials.
Joined Parexel as an Imaging Research Associate on clinical trials utilizing medical imaging.
Forge the relationships that elevate customer experience
Corporate Vice President, General Manager – Japan
Vice President, Growth Accounts
Senior Director of Business Development at Parexel.
Associate in the Proposal Development department at Parexel.
One of the founders and Marketing Director of an IT venture company developing web related systems
Voice the ideas that get treatments to patients faster
Promoted to Senior Director of Clinical Application Development and Technology.
Promoted to Associate Director of IT.
Promoted to Senior Programmer.
Joined Parexel in Clinical IT.
Received Master's in Computer Applications.
Own the challenges, program your future
Promoted to Senior Manager, Statistical Programming, with increasing responsibilities for department development and team supervision.
Advanced to Statistical Programming Manager, responsible for a dynamic, multinational team of over 12 people.
Increased responsibility, leading projects and managing small teams as a Principal Statistical Programmer / Associate Manager.
Promoted to Senior Statistical Programmer, participating in high profile trials for diverse range of sponsors, as main programmer.
Referred by a friend to join Parexel as a Statistical Programmer, taking the opportunity to further develop my programming skills in 4GL language using SAS® .
Natalia – Head of Biotech Operations for Americas East
Ruben – Senior Director
Deborah – Senior Manager
Scientific Data Technology Director
Nicholas – Senior Medical Writer
Shigehiro – Corporate Vice President, General Manager – Japan
Naresh – Senior Director of Clinical Application Development
Pawel – Senior Manager
Jobs at Parexel
Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.
Senior Clinical Feasibility Leader
Romania - Any Region - Home Based
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
This role can be office or home based in the UK, Ireland, Lithuania, Spain , Italy, Hungary, Czech Republic, Netherlands, Russia, Serbia, Lithuania, Romania or Poland. The offices are open planned, and you will be working in an innovative and collaborative environment with your international peers and colleagues.
You will act as the senior functional lead assigned as part of the core project team responsible to drive all feasibility and site identification activities immediately after award on all types and phases of studies including programs. Working independently, you are responsible for delivering an optimized operational strategy, based on selection of countries and clinical sites best positioned to successfully execute the trial/program. You will act as a mentor for
other staff in the department by engaging them in all types of feasibility and site identification activities through the mentorship period. Depending on the business needs, you will occasionally lead pre-sales feasibility assessments in support of strategic bids for mega studies or partnership programs. You must demonstrate excellent communication and leadership skills resulting in the completion of all deliverables within required timelines meeting departmental quality standards. Strong analytical skills are a pre-requisite to the job to allow you to fully adopt a consistent data-driven approach to feasibility and site identification.
Protocol Feasibility & Country Selection
- Through in-depth review of protocol design, competing landscape, and recruitment benchmark data, conduct
initial protocol feasibility assessment or revise pre-award protocol feasibility assessment taking into account new
data received/collected after award via standard and nonstandard sources of information as appropriate.
- Conduct initial country selection analysis or adjust preaward country selection analysis via available country
selection tool/platform based on new data received/collected after award using standard and nonstandard sources of information as appropriate.
Develop and implement program-specific site identification strategy to produce initial lists of sites as per departmental and partnership quality standards.
- Using the standard template, design a program-specific site questionnaire based on the available study information, the Sponsor questionnaire if any, and agreed site selection criteria that will enable an in depth analysis of the responses and will highlight the protocol challenges as viewed by the investigators as well as enable the selection of most appropriate sites.
- Independently act as Project Leader on stand-alone feasibility studies, which includes the following additional responsibilities: Sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, project management, including milestone planning and tracking, ensuring that projects are
progressing according to contract and quality standards, production of key project progress reports, and management of communication between Parexel project team, Sponsor, contract and financial management.
- Provide oversight and support pre-award activity when needed.
- Preferred degrees may include but are not limited to: Bachelor of Science, Bachelor of Science in Nursing, Masters, MD, PhD and/or comparable life skill experience
- Strong analytical skills applied to business needs
- Excellent interpersonal, verbal and written communication
- Demonstrated leadership and mentoring capabilities, and ability to influence others
- Creative problem-solving skills, which supports client-focused approach to work
- Ability to adapt to change with respect to work assignments and new learning opportunities
- Ability to prioritize workload with while maintaining quality and attention to details
- Capability and willingness to work in a matrix environment and values the importance of teamwork
- Ability to work independently and in a decentralized reporting model (as applicable).
Knowledge and Experience:
- Relevant clinical research experience in management of international clinical trials
- Demonstrated expertise of feasibility requirements
- Previous exposure to development of clinical trial strategy, modeling of enrollment scenarios, and selection of country/sites
- Fluent in written and spoken English.
In return we will be able to offer you a structured career pathway and encouragement to develop within the role including awareness and understanding of the industry. You will be well supported and for your hard work you will be rewarded with a competitive base salary as well as a benefits package including holiday, pension as well as other leading-edge benefits that you would expect with a top company in the CRO Industry.
Apply today to begin your Parexel journey!
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