Employer Sponsored Job (Free to apply to)
Clinical Research Manager (FSP)
PAREXEL International Corporation
Jobs at Parexel
We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it
Clinical Research Manager (FSP)
United Kingdom - Any Region - Home Based
Parexel FSP is currently hiring for a Clinical Research Manager home-based in the United Kingdom.
If you are looking to join a culture of teamwork and collaboration this could be the ideal role for you
Single sponsor dedicated to a top 10 Pharma that is making a real-world impact on patients and a top investor in biopharma R&D with a wide, robust pipeline of game-changing clinical Projects.
This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, quality standards, and adverse event reporting requirements internally and externally. For certain studies, the CRM could be responsible for several countries in a cluster.
· Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
· Responsible for project management of the assigned studies: pro-actively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and closeout.
· Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
· Performs Quality control visits as required
· Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across the different local country roles ensuring a strong collaboration.
· Responsible for creating and executing a local risk management plan for assigned studies
· Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.
· Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate).
· Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
· Country POC for programmatically outsourced trials for assigned protocols.
· Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets).
· Collaborates internally with HQ functions and locally with PV, Regulatory, and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
· As a customer-facing role, this position will build business relationships and represent the company with investigators.
· Shares protocol-specific information and best practices across countries\\clusters.
· Bachelor’s degree in science (or comparable).
· Advanced degree, (e.g., master’s degree, MD, Ph.D.)
· At least 8 years of experience in clinical research.
· CRA experience.
· At least 5 years of monitoring experience.
· Solid project management or people management experience.
· In-depth knowledge of departmental, protocol, and study-specific operating procedures, consent forms, and study schedules.
· Effective written and verbal communication skills including good command of the English language.
About Parexel FSP:
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.
Last verified - 0 day(s) 11 hour(s) ago [What does Last Verified mean?]