Manager, Clinical Research

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.

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.