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We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Job Summary
The position of Clinical Trials Project Manager (CTPM) has primary responsibility for execution and oversight of clinical trials assigned to them. The CTPM will be responsible for site start up and maintenance, ensuring patient enrollment and managing study resources. This role works in partnership with the Sr Clinical Research Manager (SCRM) who is responsible for overall performance of the study and overseeing all aspects of clinical research including medical monitoring, safety reporting and communications, and interactions with investigators and IRB/IECs.
Responsibilities:
Manage the day-to-day operations of assigned studies, including but not limited to:
Coordinating & scheduling various meetings such as investigator meetings, case conferences, local ethics committee submissions and approvals, etc.
Overseeing study milestones, proactively identifying potential delays and developing strategies to resolve issues in a timely manner.
Interfacing with vendors as applicable; manpower providers, Central IRB vendors, etc.
Developing strong relationships internally with other departments such as Medical Monitoring, Safety Reporting, Patient Access, HQ Regulatory Affairs, etc. and externally with sites and investigators.
Reviewing data listings periodically during study conduct to identify trends or discrepancies.
Participating in conference calls with sites to address any site questions or concerns.
Collaborating with the SCRM on study strategy, including enrollment projections and risk management plans.
Communicating regularly with headquarters regarding study status updates, including progress towards enrollment goals, site performance, and other relevant information.
Ensure compliance with internal SOPs and external regulations throughout all phases of the trial.
Contribute to the development of study materials such as manuals, instructions, and amendments.
Qualifications: Minimum Requirements:
Bachelor's degree in Science, Pharmacy, Nursing, Public Health, Business Administration or related field preferred. Associates Degree required with minimum of 4 years of relevant experience OR High School Diploma / GED equivalent with minimum of 6 years of relevant experience.
At least 2 years of previous work experience in clinical research including management of clinical trials and site personnel.
Demonstrated ability to effectively manage multiple tasks simultaneously while meeting established deadlines.
Strong organizational skills with attention to detail and quality.
Excellent verbal and written communication skills.
Proficiency in Microsoft Office Suite applications (Outlook, Word, Excel, PowerPoint).
Ability to travel domestically and internationally approximately 10% of working time.
Preferred Requirements:
Experience with Electronic Data Capture systems (e.g., Medidata Rave, Oracle Clinical, eTMF, etc.).
Experience in peripheral intervention clinical research.
Working knowledge of ICH/GCP principles and regulatory requirements.
Knowledge of Good Documentation Practices.
Experience working in a matrix environment.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
