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NS Pharma, Inc. · 1 day ago

Manager, Clinical Research

Paramus, NJ

Full-time

Hybrid

Mid, Senior Level

$110K/yr - $135K/yr

3+ years exp

NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. The Manager, Clinical Research will manage and support the execution of assigned global clinical studies while ensuring adherence to all relevant regulations including FDA and ICH requirements.

Health CareMedicalPharmaceutical

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

Qualification

Clinical operationsDrug developmentProject managementRegulatory complianceVendor managementCommunication skillsOrganizational skillsTeam playerAdaptability

Required

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

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