Manager, Clinical Research

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Professional PARAMUS NJ HYBRID, Paramus, NJ, US

12 days ago Requisition

Salary Range: $ To $ Annually

NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan.

Job Summary

This is an individual contributor role that supports the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH, local Regulatory requirements and NS Pharma standard operating procedures.

This is a hybrid position that requires to travel to the Paramus, NJ office at least twice a week.

Essential Duties and Responsibilities

• Assist in the planning, implementation and management of assigned regional or global clinical studies.
• Maintain oversight of assigned study vendors (e.g. central labs).
• Perform assigned activities in the selection of clinical sites.
• Attend and participate in site visits including pre-study assessments, site initiations, co-monitoring and ad-hoc site visits based on the study’s needs.
• Review site visit reports, identify issues and ensure issues are resolved.
• Oversight of patient recruitment and development of recruitment strategies and plans.
• Track, review, report and present study metrics including enrollment, protocol deviations, issues, risks, data resolution, and other study related metrics.
• Support the development of study related documentation (protocol, ICF, CRF, operations manuals, etc.); facilitate internal review of these documents as assigned.
• Tracking of clinical data, regulatory documents, and patient
• Assure compliance of investigational sites with SOPs, FDA regulations, ICH guidelines and protocol requirements.
• Facilitate internal review of clinical trial agreements and ancillary agreements..
• Implement and maintain study-specific training program.
• TMF oversight review during study conduct and TMF management during study closeout.
• Support creating and maintaining clinical SOPs as part of global QMS.
• Perform administrative tasks (e.g. setting-up and facilitating meetings, clinical registrations).
• Perform other tasks and functions as needed.

Qualifications

• Thorough understanding of clinical operations including strong knowledge on essential documents as related to the planning, launching, and closing clinical studies.
• Must be able to manage and coordinate with the Clinical Lead(s), Study Manager(s), Operations Program Lead and study team members at Headquarters Office in Japan to achieve study objectives and team goals.
• Must have the ability to identify and manage/solve study team’s performance issues if they arise with minimal supervision.
• Must have demonstrated ability to support the development and management of various aspects of the study operational plans from start-up to close-out.
• Must be able to work effectively in a multi-cultural, global team environment and support drug development collaboration with global project teams, Headquarters Office in Japan, external partners and vendors.
• Ability to handle multiple tasks and prioritize.
• Strong organizational, attention to details, communication and presentation skills.
• Team player, flexible, ability to adapt to change.
• Ability to interact with Investigators in-person to discuss protocol requirements and study drug.
• Ability to travel 15-25% monthly within the US and/or outside of US.

Education and/or Experience

• Bachelor’s Degree in sciences (highly preferred) or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience
• Minimum of 3 to 5 years drug development…