Clinical Supplies Project Leader

OBJECTIVE:

The primary function of this position is to support clinical trial material (CTM) packaging, labeling and distribution for US and international clinical trials. This includes reviewing multiple protocols in multiple therapeutic areas to determine supply requirements and proposing optimal packaging strategies, forecasting study and compound supply needs, monitoring retest dates of bulk drug, packaged supplies and ancillary supplies, and coordinating the entire clinical supply process with both internal departments and external vendors.



ACCOUNTABILITIES:

Review clinical study protocols to determine the clinical trial material (test product, active comparator, placebo, companion medication, ancillary product) requirements, including proposing optimal packaging strategies to ensure timely delivery of supplies, and writing the clinical supply section of the protocol.

Design protocol specific labeling that is in compliance with applicable regulations and ICH guidelines.

Coordinate blinding requirements including randomization codes to meet the goals of the clinical study.

Forecast and calculate study and compound supply needs, generate study budgets.

Coordinate the packaging, labeling and distribution of CTM with contract vendors, including selection of vendor and agreement development.

Ensure that compatible packaging materials are used for CTM by coordinating packaging activities with CMC and QA.

Monitor and track retest/expiration dates of CTM, by coordinating with CMC and QA to obtain extensions, or develop a replacement strategy if extensions are not possible.

Interact with CMC, Strategic Development or others regarding technical issues effecting the clinical trial material.

Interface with IVRS vendors for drug supply management as applicable.

Present protocol-specific CTM at Investigator meetings.

Assist in auditing project related invoices to ensure accuracy of information.

Maintain constant communication concerning CTM status with study team members and vendors.

Develop/write functional SOP's as required. Suggest and help drive key redesign or functional area process improvement initiatives as required. REQUIREMENTS
EDUCATION, EXPERIENCE AND SKILLS: Required:

At least 3 years experience in a GMP environment in R&D in pharmaceutical industry.

At least 2 years experience with distribution of clinical supplies and inventory control.

Bachelors Degree in Pharmacy, Biology, Chemistry, Nursing or other health sciences, or equivalent experience. Desired:

Previous experience in the coordination of CTM with contract vendors.

Previous experience with the coordination of CTM for international clinical studies.

Clinical development experience.

Project Management experience.

Manufacturing/logistics experience.

Degree in Pharmacy or Nursing from an accredited college or university. Skills:

Analytical Skills - ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and recommends possible solutions to the problem.

Organizational Skills - ability to balance multiple projects at once with appropriate prioritization.

Communication Skills - ability to expresses one's self clearly and concisely to customers over the phone or with others within team; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate for the audience.

Compliance Analysis - ability to review systems, processes and policies to ensure compliance with required cGXP's.

Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to the achievement of personal and team goals.

Presentation Skills - ability to give professional and concise presentations at internal and external meetings. Knowledge:

CTM - thorough understanding of the clinical packaging and labeling process supporting R&D in the U.S and abroad. Thorough knowledge of the phases and processes within the clinical development environment.

Regulatory Knowledge - understands current good manufacturing practices (cGMP), current good clinical practices (cGCP) and ICH guidelines as applicable to the packaging, labeling, and distribution of CTM.

Industry Knowledge - basic understanding of the drug development process in pharmaceutical industry. Product Knowledge - able to understand medical/therapeutic impact of products; understanding of potential product applications.

TRAVEL REQUIREMENTS:

Requires approximately 5% travel.



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