Clinical Research Sr. Manager
Company: NS Pharma, Inc.
Posted on: June 22, 2022
Job SummaryManage the execution of assigned global clinical
studies with adherence to all relevant regulations including FDA,
ICH and Regulatory requirements.Essential Duties and
Responsibilities (Include but not limited to the following. Other
duties may be assigned.)
- Assist to plan, implement, manage and report for regional or
global clinical studies.
- Manage selection process of CROs for regional or global
- Manage the performance of study vendors (e.g. CROs and central
- 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
- 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
- Coordinate negotiation of clinical trial contracts between
investigational sites and CROs.
- Manage data management vendors and statistical analysis vendors
to ensure timely analysis output delivery in accordance with
Statistical Analysis Plan.
- Support for coordination with clinical suppliers to ensure
appropriate and timely delivery of clinical trial supplies to
- Implement project specific training program and training
- Support Creating and maintaining clinical SOPs and TMF as part
of global QMS and TMF processes.Qualifications
- Must be able to manage and coordinate with the Clinical Lead 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, launching, and closing clinical
- Ability to handle multiple tasks and prioritize.
- Strong organizational, communication and presentation
- Team player, flexible, ability to adapt to change.Education
- Bachelor's Degree in sciences or related field with a minimum
of 5 years of pharmaceuticals/biotech experience.
- Minimum of 5 years drug development experience in the
pharmaceutical industry/CRO or commensurate clinical/medical
research experience with emphasis on Phase II-IV clinical
- Program and project management experience preferred.
Keywords: NS Pharma, Inc., Paterson , Clinical Research Sr. Manager, Healthcare , Paramus, New Jersey
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