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Country Trials Manager - FSP
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.
Country Trials Manager - FSP
USA - Any Region - Home Based
ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.
Job Title: Country Trials Manager (CTM)
The Country Trials Manager (CTM) is responsible for study startup deliverables for assigned studies at a country level of limited or moderate complexity. The Country Trials Manager partners with the Study Start Up Project Manager (SUPM), Study Manager (SM), Site Intelligence Lead, Site Relationship Partner (SRP), Site Activation Partner (SAP), Contracts Lead, Regulatory Affairs, CRO representatives and others as required. The Country Trials Manager provides leadership and country strategic planning and organization skills to ensure the delivery of operational Start up aspects of one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.
Accountable for the execution of:
• Country level implementation of Startup and Site Activation Plans
• Country level Recruitment Strategy
• Timely and quality Ethics Committee (EC)/Regulatory Authority (RA) Submissions • Communication with internal stakeholders as listed above to ensure efficient and timely study startup delivery at a country level
Responsible for Study and Site Start Up on a Country level:
• Manages the study start up process in countries assigned
• Supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements • Provides country level input on Startup and Recruitment milestones to Global Study Team during planning
• Is accountable for delivery of startup and site activation for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g., timelines, budget, risk and quality plans)
• Highlights deviations and risks in startup and site activation plans to relevant parties, develops and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation (both at the study and site level)
• Attendance at SSU meetings. Ad-hoc member of the Operational Study Team Meetings
• Leader of the Local Study Team (core members: Country Trials Manager, Site Relationship Partner, Site Activation Partner, ad hoc members: Contracting, Regulatory, Medical Affairs colleagues and other key stakeholders)
• Ensures timely communication bidirectionally between the global and local study team
• Provides protocol level guidance and support to responsible Local Study Team members as applicable
• Liaise with Global Site and Study Operations and Regulatory colleagues and country colleagues to agree on submission strategy to Health Authorities and Ethic Committees
• Provides Global Teams with local intelligence. Acts as the main point of contact for all study-level questions for the Local Study Team, liaising with and escalating to appropriate global roles/teams Follows up on country level issue status to ensure resolution. Identifies start up country level trends to improve start up processes as needed
• Ensures compliance to relevant Global and Local, internal and external processes
• Ability to successfully liaise with global roles in support of successful CT (clinical trial) implementation at a country level
Skills and Education:
• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/ experience: BS/BSc/MS/MSc; a nursing diploma or associate degree in nursing may also be considered with extensive clinical trial experience
• Operational clinical trial experience
• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
• Fluency in English and region/country local language are required
• Prior Experience Preferred:
• 5 years of clinical research experience and/or study management/startup project manager experience
o Demonstrated knowledge of site selection, site activation, site readiness interdependencies
o Demonstrated knowledge of clinical trial methodology and the drug development process
o Demonstrated experience leading cross functional teams
o Demonstrated experience in Project Management and Quality management
o Demonstrated experience in a matrix management environment
• Expertise in the use of Site Activation tools
• Detail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management)
• Ability to manage complex processes
• Ability to manage in a matrix environment
• Risk Identification and Mitigation
• Strategic Planning, Analytical and Problem-Solving Skills
• Critical Path Analysis
• Excellent communication skills, both written and verbal
• Ability to adapt to changing technologies and processes
• Seeks to develop an integrated view of key issues to shape decisions and strategy development
• Proactively manages change by identifying opportunities and coaching self and others through the change
• Ability to introduce new ideas and implement them
• Effectively overcoming barriers encountered during the implementation of new processes and systems
• Builds effective relationships with customers and other stakeholders
• Works well across country boundaries, respects communication and cultural differences in interpersonal relationships
• Effective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organization
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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