Jobs at NS Pharma, Inc. (Now Hiring) — 13 open

• Plan, implement, manage and report for regional or global clinical studies.
• Manage and Lead selection process of CROs for regional or global clinical studies.
• Manage the performance of study vendors (e.g. CROs and central labs). 
• Coordinate and collaborate with the Clinical Lead to achieve project objectives.
• Manage and resolve project performance issues (issue management) if they arise.
• Manage activities for clinical site selection and activation, investigator meetings and study initiation.
• Manage, provide guidance and direction to Sr. Manager(s).
• Oversight of patient recruitment and development of recruitment strategies and plans.
• Responsible 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.
• Coordinate data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan.
• Responsible for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites.
• Implement project specific training program and training material development.
• Create and maintain clinical SOPs and TMF as part of global QMS and TMF processes.
• Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.).
• Supervise at least one (1) Sr. Manager in Clinical Research. Responsible for their performance management including professional development.

Qualifictaions:

• Experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets. 
• Good cross-functional team leader who fosters team spirit and team motivation (teamwork)
• Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, NS Pharma Japan (HQ), external partners and vendors.
• Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies.
• Ability to anticipate and timely escalate issues and to define appropriate action plans
• Decision-making and problem-solving skills
• Ability to handle multiple tasks and prioritize
• Strong organizational, communication and presentation skills
• Team player, flexible, ability to adapt to change

Education and Experience:

• Bachelor’s Degree in sciences or related field with 8 + years of pharmaceuticals/biotech experience. Certified Project Management Professional (PMP) preferred.
• Minimum of 8 + years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials. Hematology - oncology clinical trial experience is preferred.
• Rare Disease experience preferred
• Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc.)
• Program and project management experience preferred.