Sr. Clinical Supply Manager

Position Title: Sr. Manager, Clinical Supply

Location: ASSM

Department: Clinical

Shift: 1st

Reporting To: Director, Clinical Supply Chain

Responsible For (Staff): None

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The Sr. Clinical Supply Manager supports PCI Clinical Service Customers by bringing PCI's experience to the clinical trial, providing expertise throughout the clinical study supply lifecycle. Acts as the single point of contact in coordinating the necessary information between clinical functions, ensuring that clinical supplies are available in appropriate quantities where and when they are needed to support a global clinical study.

• Forecast clinical supply demand and manage clinical supply inventory throughout the clinical trial globally

• Adjust re-supply strategies by assessing clinical protocol revisions and analyzing enrollment rates, inventory usage, and trends

• Utilize simulation tools and supply chain expertise to determine packaging campaign and distribution strategies

• Work with IXRS vendors in creation of system specification for supply algorithms and manages drug supply portion of IXRS development for clinical trials

• Manage clinical supply depot set-up and monitor depot inventory throughout study

• Manage clinical drug for a wide range of study types, including packaging design and contingency planning

• Build drug projections, distribution strategy, packaging schedules, as well as managing/monitoring depot and site inventory levels

• Act as client advocate, assisting with study set-up with CRO

• Work in an unblinded capacity with secure, confidential study information

• Participate in high level cross-functional teams

• Manage the project budget (protocol and program level)

• Participate in CMC meeting to help manage expectations and ensure clear communication

• Supports comparator procurement strategies

• Requests manual drug orders as needed

• Manage/monitor/procure ancillary and comparator supplies inventories

• Provide final drug accountability reports to Clinical group

• Coordinate drug return, accountability, and destruction process

• Will manage IMP across multiple clinical trials when necessary

• This position may require overtime and/or weekend work

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules

• Attendance to work is an essential function of this position

• Performs other duties as assigned by Manager

• Attends Investigator Meetings, as needed

• Provides input for protocol development/amendment, as needed

Special Demands:

• Stationary Position: From 1/4 to 1/2 of the day.

• Move, Traverse: From 1/4 to 1/2 of the day.

• Operate, activate, use, prepare, inspect, or place: None

• Install, place, adjust, apply, measure, use, or signal: None

• Ascend/Descend or Work Atop: None

• Position self (to) or Move (about or to): Up to 1/4 of the day

• Communicate or exchange information: 3/4 of the day and up

• Detect, distinguish, or determine: 3/4 of the day and up

Required:

• Bachelor's Degree in a related field and/or 5-7 years related experience and/or training

• College Level Mathematical Skills

• Intermediate Computer Skills:
  Ability to perform more complex computer tasks and has knowledge of various computer programs

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs

• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables

Preferred:

• Ability to effectively present information to various people as the job requires

• Ability to work independently and/or part of a team

• Ability to display excellent time management skills

• Ability to display a willingness to make decisions

Equal Opportunity Employer/Vet/Disabled