Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Senior Clinical Trial Manager overseeing clinical trials to ensure compliance and smooth operations at Genmab. Requires extensive experience in clinical operations and cross-functional team collaboration.
Responsibilities
- Develop and manage operational plans, charters, and manuals to support trial execution in compliance with regulatory and internal standards.
- Review of protocol and protocol amendments
- Coordinate the development of and manage updates of the Trial Oversight Plan
- Review of the Investigator's Brochure from DevOps perspective
- Review of the Clinical Trial Application submission package as well as supporting the response to Health Authority questions
- Review of Regulatory Green Light packages
- Review the Development Safety Update Report
- Develop the Global Master ICF
- Act as a key liaison between internal stakeholders and CROs to oversee sponsor oversight visits and ensure quality and compliance across all activities.
- Collaborate with the CRO and/or internal functions to oversee site selection based on feasibility assessments, aligning site readiness with trial timelines.
- Coordinate the review of country-specific informed consent forms with internal stakeholders
- Monitor and manage vendor deliverables across trial operations, ensuring alignment with trial goals and timelines
- Participate in the selection and approval of key CRO personnel, such as Clinical Leads and trial-specific CRAs, to ensure their expertise aligns with trial demands.
- Responsible for trial specific protocol deviation guidance and ongoing protocol deviation assessments and trend tracking
- Ensure ongoing accuracy and completeness of the eTMF, supporting inspection readiness and regulatory compliance.
- Maintain relevant sections in Clinical Trial Management Systems and Tools
- Drive the Operational Data Base review for the trial
- Engage in Risk Based Quality Management activities to enhance data quality and monitoring practices, addressing potential risks proactively.
- Responsible for maintenance of the Clinical Trial Team issue log in collaboration with Global Clinical Trial Manager Support GCTM in assessing key performance indicators (KPIs) at the trial level and manage escalation procedures for internal and external stakeholders.
- Participate in inspection readiness activities, support QA in audit preparations, and conduct site visits as needed.
- Oversee the tracking and reconciliation of trial-related items, such as scans and blood samples, ensuring trial data accuracy and completeness during trial closeout.
Requirements
- Bachelor's or Master's degree with relevant specialization
- Minimum requirement: 8+ years in clinical operations
- Significant experience leading and managing clinical trials
- Experience in leading multiple complex trials, maintenance of trial documentation, CRO engagement, and budget monitoring
- Some experience managing/guiding internal (cross-functional) and external (CRO) teams
Benefits
- Remote working options
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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