Manager, Clinical Research

NS Pharma Inc • Paramus, NJ

4d • $110,000 - $135,000 • Hybrid

About The Position

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.

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 role that requires employees to come into the office twice a week.

Requirements

• 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.
• 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 experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials.

Nice To Haves

• Program and project management experience preferred.
• Global clinical trial experience is also preferred.

Responsibilities

• Assist in the planning, implementation and management of assigned regional or global clinical studies.
• Facilitate CRO./vendor selection process.
• 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.

Benefits

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs
• Discretionary Bonus Programs and Long-term Incentive Plan
• Retirement Savings 401k with company match
• Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown.
• Career Development, Progression and Training
• Flexible Work Arrangement Programs

What This Job Offers

• Job Type: Full-time
• Career Level: Manager