This job is a 12 month contract possible right to hire. Must be ok in a Hybrid Setting. Must be a US Citizen or Green Card holder to apply.
Job Description:
This role includes - hybrid work schedule. Need to have some flexibility with work hours as person will work with managers in Denmark and Netherlands.
Support the Clinical Trial Manager (CTM) and the CMT on operational aspects related to trial conduct to ensure compliance and quality of the trial
With some guidance, conduct clinical trial support activities related to assigned trials (including coordination and documentation for CTM; critical documentation including sponsor TMF, record management, trial documentation; etc.)Â
As directed, provide ongoing support to trials in terms of logistics management, sponsor oversight support, and coordination for outsourcing and contract management
As required, assist with insurance tracking and coordination as well as budget tool maintenance
Responsibilities:
**Overview**
This role includes - hybrid work schedule. Need to have some flexibility with work hours as person will work with managers in Denmark and Netherlands.
The (Senior) Clinical Trial Manager (CTM) plays a key role in supporting Clinical Trial Teams (CTT) and ensuring smooth trial operations. CTMs may be assigned various tasks to support clinical trial planning, execution, and oversight of clinical trials to ensure they are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and clinical trial protocols. The CTM works cross-functionally with study teams, investigators, and vendors to ensure trial objectives are met on time and within budget. A Senior Clinical Trial managers are expected to assume roles and responsibilities with more autonomy.
**Roles & Responsibilities**
**Â Trial Planning and Oversight**
- 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 ICFÂ
- Act as a key liaison between internal stakeholders and CROs to oversee sponsor oversight visits and ensure quality and compliance across all activities.
**Site Selection and Management**
- 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
**Vendor Management and Oversight**
- 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.
**Trial Execution and Monitoring**
- 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.
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