13 Clinical Supply Specialist Jobs in King of Prussia, PA
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Clinical Supply Specialist
$62k-78k (estimate)
Contractor | Business Services
1 Week Ago
System One is Hiring a Clinical Supply Specialist Near King of Prussia, PA
Title: Clinical Supply Specialist
Location: King of Prussia, PA, onsite position
Standard Hour Per Week: 40 hours
Contract Length: 12 months
Notes
Essential Duties And Responsibilities
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Location: King of Prussia, PA, onsite position
Standard Hour Per Week: 40 hours
Contract Length: 12 months
Notes
- Must Have: Excel, IRT skills
- Nice to Have: Clinical Label Experience
Essential Duties And Responsibilities
- Assist with planning and execution of clinical packaging projects, including oversight of CMO scheduling, production of labels, and packaging of clinical trial supplies
- Review clinical trial protocols and understand impact on supply
- Coordinate and track drug shipments
- Monitor inventory at depots, sites, and distribution points
- Perform drug accountability with depots/clinical sites and Sponsor inventories
- Act as point of contact for third-party storage, distribution, and packaging vendors
- Maintain traceable documentation to support GXP activities
- Has the potential opportunity to manage clinical projects
- Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are labelled and released for clinical site shipment for global clinical trials
- Design and/or review label text to meet product requirements and ensure compliance with US and international regulations
- Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners
- Utilize appropriate software and IT systems to effectively manage key project activities
- None
- BS/BA degree in related discipline and at least three years of related experience; or,
- MS/MA degree in related discipline and at least one year of related experience; or,
- Equivalent combination of education and experience.
- Certification in assigned areas is a plus
- Typically requires a minimum of 2-5 years of related experience and/or combination of education and experience
- Demonstrate experience with clinical supply management planning, labeling, packaging, and distribution
- Willingness to work in a fast paced, evolving environment
- Clinical Supply management experience using contract manufacturing companies strongly preferred
- Knowledge of GMP batch record development, review, and approval processes
- Knowledge of Interactive Voice/Web response systems for use in clinical studies.
- Working knowledge of regulations relating to clinical labeling, packaging, and distribution activities
- Working knowledge of GMP/GCP/GLP regulations required
- Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways
- Excellent project management and communication skills
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
- Exercise judgment in selecting methods, techniques, and evaluation criteria for obtaining results
- Networks with key contacts outside own area of expertise
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Job Summary
JOB TYPE
Contractor
INDUSTRY
Business Services
SALARY
$62k-78k (estimate)
POST DATE
06/24/2024
EXPIRATION DATE
09/18/2024
WEBSITE
healthsystemone.com
HEADQUARTERS
MIAMI, FL
SIZE
25 - 50
TYPE
Private
CEO
JOSEPH BRUCE
REVENUE
$10M - $50M
INDUSTRY
Business Services
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