Manager, Clinical Research

Company: NS Pharma Inc
Location: Paramus
Posted on: February 17, 2026

Job Description:

Job Description Job Description 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: Manage and support the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. This is a hybrid role that requires employees to come into the office twice a week. Essential Duties and Responsibilities: Assist to plan, implement, manage and report for regional or global clinical studies. Manage selection process of CROs for regional or global clinical studies. Manage the performance of study vendors (e.g. CROs and central labs) Manage activities for clinical site selection, investigator meetings and study initiation. Oversight of patient recruitment and development of recruitment strategies and plans Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.) Tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans. Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols. Coordinate negotiation of clinical trial contracts between investigational sites and CROs. Manage assigned vendors to ensure timely analysis output delivery in accordance with vendor-specific plan. Support coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites. Implement project specific training program and training materials Support creating and maintaining clinical SOPs and TMF as part of global QMS and TMF processes. Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.). As needed and required perform other tasks and functions. Qualifications: Must be able to manage and coordinate with the Clinical Lead and Study Manager to achieve project objectives and able to manage/solve project management performance issues if they arise. Demonstrated ability to support the development and management of various aspects of the end to end study operational plan. Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners and vendors. Thorough understanding of clinical operations involved as related to the planning, conducting, and closing clinical studies. Ability to handle multiple tasks and prioritize. Strong organizational, communication and presentation skills. Team player, flexible, ability to adapt to change. Must be able to travel within the US and outside of US 15-25% monthly and interact with Investigators in-person regarding the protocol and study drug. Education and Experience: Bachelor’s Degree in sciences 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. Program and project management experience preferred. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $110,000 to $135,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: 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 Applications will be accepted until January 19, 2025, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Keywords: NS Pharma Inc, Scranton , Manager, Clinical Research, Science, Research & Development , Paramus, Pennsylvania