Clinical Trials Materials Manager - San Diego, CA | Biospace
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Clinical Trials Materials Manager

Dart NeuroScience LLC

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Location:
San Diego, CA
Posted Date:
4/17/2017
Position Type:
Full time
Job Code:
17-015 #801050
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Trial, CMC,

Job Description

The Manager of Clinical Trials Materials (CTM) Management is responsible for overseeing and ensuring the clinical supply needs for multiple clinical development programs. The successful candidate will work closely with Clinical Development, Clinical Operations, Regulatory Affairs, Manufacturing, and Quality Assurance to make certain that CTM are available for ongoing studies. To support programs, the manager will identify, negotiate, and manage packaging, labeling and distribution CROs who will provide the primary logistics of CTM supply to support both domestic and global studies. Additionally, he/she will track inventory levels to ensure demand requirements are met, safeguard against expiry dates lapses that could cause study delays, and handle re-supply of CTM in a seamless fashion. The manger will contribute to the development, review and acceptance testing of IRT systems, work closely with Clinical Operations to monitor and review enrollment plans and modify supply chain logistic plans as required.

Roles and Responsibilities:
• Coordinate logistics and distribution of CTM for both U.S. and international clinical studies
• Identity, negotiate with, and manage CROs and vendors that will package, label, and distribute CTM for worldwide clinical trial
• Review clinical trial protocols and understand their impact on CTM
• In collaboration with Clinical Operations, identify demand assumptions, enrollment rates, number of sites, number of countries to understand CTM requirements
• Collaborate with Manufacture and Quality to ensure that CTM manufacture and release meet the needs of clinical studies
• Work directly with IRT vendors to define specification, acceptance, and implementation of the IXRS
• Monitor inventory levels and expiry dates of CTM at depots and clinical sites throughout the duration of clinical studies to proactively prevent downstream supply issues
• Manage CTM label development and approval process
• Provide guidance towards and implement of packaging and supply strategies to maximize supply efficiency and minimize waste
• Develop risk mitigation strategies and provide contingency plans to minimize delays to study conduct
• Apply simulation tools to drive optimal clinical supply plan as appropriate
• Regularly update development project teams on ongoing CTM requirements and status
• Contribute to yearly budget generation
• Write and review SOPs, where appropriate
• Establish and maintain a strong, collaborative working relationship with internal and external stakeholders to ensure customer satisfaction

Requirements

• Bachelors in life sciences, Masters preferred
• Minimum 5 years in life sciences industry related experience, including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination
• At least 4 years direct experience in clinical supplies environment
• Proficient knowledge of Microsoft Excel, PowerPoint and Project software required
• APICS certification preferred

Physical Demands and Work Environment:
• Travel domestic and international – up to 15%

Competencies:
• Strong working knowledge of of clinical study design, implementation, and impact of CTM supply
• Familiarity with a variety of clinical trial designs (e.g. randomized, double-blind, double-dummy, placebo-controlled, open label.)
• Experience in inventory management and forecasting drug supply to support global trials
• Experience with IXRS systems, including direct knowledge of set-up and use of IXRS
• General understanding of GMP and GCP requirements for CTM
• Ability to adapt to modification and changes to clinical plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
• Excellent communication and influencing skills, strong collaboration skills
• Strong attention to detail
• Ability to multi-task and manage complexity