NS Pharma, Inc. · 3 hours ago
Manager, Clinical Research
Paramus, NJ
Full-time
Hybrid
Mid, Senior Level
$110K/yr - $135K/yr
3+ years expNS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. The Manager, Clinical Research role involves supporting the execution of global clinical studies while ensuring adherence to regulations and managing study vendors and activities.
HealthcarePharmaceuticalHealth CareMedical
Responsibilities
Assist in the planning, implementation and management of assigned regional or global clinical studies
Facilitate CRO./vendor selection process
Maintain oversight of assigned study vendors (e.g. central labs)
Perform assigned activities in the selection of clinical sites
Attend and participate in site visits including pre-study assessments, site initiations, co-monitoring and ad-hoc site visits based on the study’s needs
Review site visit reports, identify issues and ensure issues are resolved
Oversight of patient recruitment and development of recruitment strategies and plans
Track, review, report and present study metrics including enrollment, protocol deviations, issues, risks, data resolution, and other study related metrics
Support the development of study related documentation (protocol, ICF, CRF, operations manuals, etc.); facilitate internal review of these documents as assigned
Tracking of clinical data, regulatory documents, and patient
Assure compliance of investigational sites with SOPs, FDA regulations, ICH guidelines and protocol requirements
Facilitate internal review of clinical trial agreements and ancillary agreements
Implement and maintain study-specific training program
TMF oversight review during study conduct and TMF management during study closeout
Support creating and maintaining clinical SOPs as part of global QMS
Perform administrative tasks (e.g. setting-up and facilitating meetings, clinical registrations)
Perform other tasks and functions as needed
Qualification
Required
Thorough understanding of clinical operations including strong knowledge on essential documents as related to the planning, launching, and closing clinical studies
Must be able to manage and coordinate with the Clinical Lead(s), Study Manager(s), Operations Program Lead and study team members at Headquarters Office in Japan to achieve study objectives and team goals
Must have the ability to identify and manage/solve study team's performance issues if they arise with minimal supervision
Must have demonstrated ability to support the development and management of various aspects of the study operational plans from start-up to close-out
Must be able to work effectively in a multi-cultural, global team environment and support drug development collaboration with global project teams, Headquarters Office in Japan, external partners and vendors
Ability to handle multiple tasks and prioritize
Strong organizational, attention to details, communication and presentation skills
Team player, flexible, ability to adapt to change
Ability to interact with Investigators in-person to discuss protocol requirements and study drug
Ability to travel 15-25% monthly within the US and/or outside of US
Bachelor's Degree in sciences (highly preferred) 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
Preferred
Program and project management experience preferred
Global clinical trial experience is also preferred
Benefits
Medical, Dental & Vision Insurance
Basic and Voluntary Life and AD&D Insurance
Short- and Long-Term Disability Insurance
Flexible Spending Account
Health Savings Account
Employee Assistance Programs
Discretionary Bonus Programs
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
Company
NS Pharma, Inc.
NS Pharma, Inc.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Donald Foy
Vice President, Commercial
Jennifer Tamberino
Senior Director, Head of Sales
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