Manager, Clinical Research
29 days ago
Paramus
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. 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.)., • 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., • 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.
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