Global Clinical Research Manager - Hybrid

NS Pharma Inc; Paramus (NJ); Hybrid; USD 120,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

Discretionary Bonus Programs

Retirement Savings 401k with company  

Flexible Work Arrangement Programs

Paid Time Off, Holidays

Career Development and Training

Job summary

NS Pharma Inc., Paramus, NJ, is hiring a Manager, Clinical Research to support global clinical studies in a hybrid role. The position requires coordinating study activities, overseeing vendors, and ensuring regulatory compliance.

The role emphasizes collaboration with HQ in Japan, Site management, and active patient recruitment. Travel is expected 15-25% monthly within the US and internationally. Bachelor’s degree and 3–5 years in pharma/biotech are preferred.

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.

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.

Skills

Clinical operations

Vendor management

Study coordination

FDA/ICH regulations

Global collaboration

Travel 15-25%

Communication skills

Multi-cultural teamwork

Education

Bachelor's degree in sciences

Job description

NS Pharma Inc., Paramus, NJ, is hiring a Manager, Clinical Research to support global clinical studies in a hybrid role. The position requires coordinating study activities, overseeing vendors, and ensuring regulatory compliance.

The role emphasizes collaboration with HQ in Japan, Site management, and active patient recruitment. Travel is expected 15-25% monthly within the US and internationally. Bachelor’s degree and 3–5 years in pharma/biotech are preferred.