Sr. Manager, Clinical Supply

at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States

Job Description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
JOB DESCRIPTION:

Position Title: Sr. Manager Clinical Supply (SMART)
Location: Fully Remote
Department: Clinical PM
Shift: 1st
Reporting To: Director, Clinical Supply Chain
Responsible For (Staff): no

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
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 and lead 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.
Assists Business Development when marketing service to and visiting customers/clients, 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.

On an average day, the individual can expect to move and/or transport up to 25 pounds less than 1/4 of the day.

QUALIFICATIONS:
Required:
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.
Ability to Travel
Bachelor's Degree required
7-10 Years of Clinical Supplies Experience, majority in Supply Management at Sponsor Company
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... For full info follow application link.

LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.