Description
Job Location: England, UK
Job Location Type: Hybrid
Job Contract Type: Full-time
Job Seniority Level: Associate
What You'll Do:
- Plan, implement, evaluate, and complete full execution of assigned clinical trials; may function as a global trial lead.
- Set goals and timelines, provide oversight and positive leadership to foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned clinical trials.
- Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures.
- Provide management of full scope clinical trial projects including global trials from start-up through analysis phase; provide oversight of functionally assigned teams members on clinical trials projects; able to manage multiple projects simultaneously.
- Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities.
- Implement project activities according to scope of contracted work.
- Evaluate and manage project budget against project milestones and scope; work with the trial-assigned Director to take corrective measures where necessary to keep project in line with budget.
- Regularly assess project profit margins with trial-assigned Director at the project and project service levels and work with the trial-assigned Director and project team to understand deficiencies; support mitigation strategies to positively impact project profit margins.
- Assess scope of work against client contractual agreements and works with trial-assigned Director to facilitate change orders when appropriate.
- Prepare or provide oversight/support for development of trial plans/timelines; collaborate with the trial-assigned Director or line manager for effective solutions during challenges that arise during clinical trials.
- Participate in or provide oversight/guidance in development required deliverables.
- Serve as client contact at operational level.
- Provide oversight to contracted vendors; review specifications/maintain interactions ensuring timelines/expectations are met.
- Oversee/manage third-party vendors’ financial spend.
- With support from assigned director, review/assess KPI ensuring positive progress while actively working on mitigating activities outside expected ranges.
- Ensure appropriate tracking using computer-assisted programs enabling timely entry by all team members for accurate reporting.
- Monitor ongoing resource needs keeping functional department heads apprised about identified needs/performance issues.
- Ensure that assigned teams receive appropriate training facilitating effective protocol implementation/execution.
- Provide day-to-day CRA task oversight on projects; oversee CRA’s site management/data monitoring tasks/review site trip reports/escalate issues as needed per Project Communication Plan.
- Attend site visits as needed providing support for CTI staff/site staff/trial operations
- Lead client/team meetings enabling effective information sharing/discussion/decision-making ensuring accurate documentation is maintained post-meeting
- Prepare/provide approval/project status reports for assignments
- Participate/provide planning assistance for Investigator meetings developing agendas/materials/conduct presentations
- Ensure TMF completeness through regular audits/submission checks by all staff adhering TMF Plan accuracy/completeness standards
- Engage in business development activities upon request (RFPs/bid defense/client meetings etc.)
- Suggest/participate process improvement initiatives
- Review site/vendor invoices approving milestone payments per regional needs assisting payment projections/preparation.
What You'll Bring:
Bachelor’s degree in allied health fields such as nursing, pharmacy, health or natural sciences preferred along with relevant experience/equivalent combination education/work experience required.
At least 5 years experience required.
About CTI:
CTI Clinical Trial & Consulting Services is a global privately held full-service CRO focused on advancing treatments for chronically & critically ill patient populations assisting research throughout lifecycle from drug concept through commercialization headquartered Greater Cincinnati OH region collaborating globally pharmaceutical/biotechnology/device firms.
For more information visit www.ctifacts.com
Why CTI?
Advance Your Career – We invest in your professional growth offering structured mentoring programs/leaders courses/dedicated training departments supporting your excellence while encouraging ongoing education achieving professional goals.
Join an Award-Winning Team – Join our global team spanning across countries recognized award-winning culture prioritizing people supporting work-life balance hybrid opportunities via our CTI Cares program giving back community/worldwide.
Make a Lasting Impact – At CTI your contributions directly advance medicine playing vital role developing life-changing treatments chronic critical illness patients together moving medicine forward making difference those who need it most.
Important Note:
In light recent increase hiring scams if selected move next phase hiring process member our team will reach out directly @ctifacts.com email address guiding interview process please ensure applying jobs directly website www.ctifacts.com verified LinkedIn page
Please Note:
We will never communicate via Microsoft Teams/text message
We will never ask bank account information recruitment process
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