SUMMARY:

The purpose of this position is to manage the distribution logistics for assigned projects in support of the planning, execution, and close out of Phase I – IV clinical studies to ensure the objectives of the studies are met.
Responsibilities:

EDUCATION AND EXPERIENCE:

• Bachelor’s degree from an accredited college or university.
• 3-5 years of health sciences experience is required (pharmaceutical industry or related experience is preferred; work in the areas of clinical operations, and/or project management a plus).

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly.
• Excellent knowledge of clinical study protocols and IP related activities with particular emphasis on global distribution and strategy.
• Thorough understanding of GMP, GDP (IP production and distribution).
• Thorough understanding of IRT systems.
• Good understanding of CMC and clinical study conduct activities.
• Excellent ability to interface with customers and distribution partners (couriers, brokers, vendors).
• High attention to detail.
• Strong problem-solving skills.
• Excellent ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization, effective time management skills.
• Exercises calm, sound constructive judgment during high demanding situations.
• Proficiency using Microsoft Outlook, Word, Excel, and PowerPoint.
• Excellent oral and written English communication skills.

ESSENTIAL DUTIES & RESPONSIBILITIES:

The following statements are intended to describe the general nature and level of work being performed in this role. Other duties may be assigned.

• Manage the distribution logistics for assigned projects.
• Develop and apply the distribution strategy (for IRT and non-IRT studies) that ensures continuity of IP at depots and investigation sites.
• Ensure all critical parameters are considered for every distribution strategy; IRT specifications (e.g., initial or resupply quantities); any QP, project, study, expiry, customs, import/export, brokerage, or country specific requirements.)
• Work with relevant departments to create master labels for each study.
• Ensure adequate stock at depot and site levels.
• Support relabeling activity or transfers between sites.
• Generate and/or review shipment requests for accuracy & completeness prior to issuance.
• Ensure accuracy of IP receipt for all shipments and availability in IRT for applicable studies.
• Serve as point of contact for Returned Product Numbers.
• Ensure that final drug reconciliation is completed and accurate at site and study level.
• Serve as point of contact for all distribution activities.
• Provide adequate communication and documentation relevant to the clinical study plan and the movement of all investigational products.
• Contribute to the budgeting and forecasting for all clinical studies.
• Offer creative solutions/proposals to optimize the clinical supply chain.
• Generate and maintain data for clinical distribution metrics.
• Work closely with Assoc. Dir, Clinical Trial Supply to support on all relevant trials.