Clinical Monitoring Lead overseeing CRO activities for clinical trials at Excelya. Coordinating efforts across study phases while ensuring compliance and quality standards in a hybrid work environment.
About the role
- Clinical Operations Manager developing strategies for clinical trials at Johnson & Johnson. Managing timelines, resources, and budgets for clinical studies in the medical device sector.
Responsibilities
- Own processes and information required to execute and support the clinical trial including clinical trial project plan, project timelines, resourcing, budget plans, and statements of work
- Accountable for the preparation and finalization of key clinical documents which include the clinical protocol, informed consent, case report form, and other essential study documents
- Manage study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable Regulations and Guidelines required to gain approval for JJV medical devices
- Responsible for the selection of Contract Resource Organizations (CRO) and oversight of contracts, timelines, and budgets, when applicable
- Manage and improve clinical trial processes, including benchmarking and leveraging across other J&J companies
- Perform other related duties as assigned by management
Requirements
- A minimum 8 years of work experience
- Experience required within any of the following areas: distribution, manufacturing, logistics, supply chain, customer service, healthcare
- SAP knowledge
- Proficiency in MS Office Suite proficiency preferred, including (Word, Excel, PowerPoint, and Outlook)
- Knowledge of Warehouse Management Systems
- Demonstrated initiative, creativity, assertiveness, and proactive communication
- Strong interpersonal and communication skills
- Kaizen/Greenbelt, LEAN Certification (preferred)
- Validated understanding of enterprise resource platforms and warehouse management systems (preferred)
- Experience building reports with visualization programs, e.g., PowerBI and/or Tableau (preferred)
- Experience Working in highly regulated industries (preferred)
- Ability and capability to lead or support projects (preferred)
- Process Excellence training and/or certification or APICS certification (preferred)
- Project Management Certification/Experience (preferred)
- Sales or Sales support role experience (preferred)
- Inventory Management experience, sterile processing, OR support or clinical experience in a hospital environment (preferred)
- Warehouse Management System (WMS) and/or Transportation systems (TMS) experience (preferred)
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year
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