Covance is seeking a Clinical Operations Manager (COM) to be remotely based in the USA!
Bilingual skills in English and French is a must!
The COM is accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Duties and Responsibilities:
•Execute and oversee clinical trial country submissions and approvals for assigned protocols
•Develop materials including local language Informed Consents and translations
•Work in partnership with IRB/IEC and Regulatory Authority on submission and approval-related interactions for assigned protocols
•Manage country deliverables, timelines and results for assigned protocols to meet country commitments
•Responsible for quality and compliance in assigned protocols in the country
•Contribute to the development of local SOPs, may oversee contract workers (CTCs) and local vendors as applicable
•Collaborate internally with GCTO country operations (CRM, CTC,CRA), CQM, Finance, Medical Affairs, Regulatory Affairs, PV, Business Compliance, Legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
•Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management
Problem solving and Process Improvement is essential to this position. It will require the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
What our employees have to say:
"The opportunities to grow are one of the top things I like about Covance. Covance really allows you to find a place to be happy. The flexibility of opportunities with Covance is just wonderful."
"One of the things that attracted me to Covance was its longstanding reputation as an industry leader. I consistently hear from sites that Covance is one of their preferred CROs to work with, which speaks volumes about the company's reputation."
Come join the Covance team, where you can help impact the lives of millions!
Problem solving and process improvement is essential to this position. requires the ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable. specific examples of common problems include: 1) issues in budget / ctra negotiations, 2) quality and compliance issues, 3) regulatory and legal
issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
• bachelor's degree (or comparable) in administration/ life science or equivalent health care related experience experience minimum preferred:
• 5-7 years clinical research experience
• extensive experience in clinical project management and coordination.
• expertise of core clinical, regulatory and financial systems, tools and metrics
• extensive knowledge of local regulatory environment and submission and approval processes.
***experience developing informed consent forms is required. eeo employer a