Sr. Manager, Clinical Supply

Sr. Manager, Clinical Supply

Locations: Rockford, IL, USA; Burlington, CAN; San Diego, CA, USA

Time Type: Full time

Posted on: Posted Yesterday

Job Requisition ID: JR112280

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.

Summary of Objective:

The Sr. Manager, Clinical Supply is responsible for developing drug supply planning strategy and overall management of supplies for all phases of clinical trials, including Phase I-IV, Expanded Access Program, and Compassionate Use. The Senior CSM role supports PCI Clinical Service Customers by bringing PCI’s clinical supply chain management experience to the clinical trial, ensuring that clinical supplies are available in appropriate quantities where and when they are needed.

Qualifications:

Required:

• College Level Mathematical Skills: Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.
• Basic 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.
• Ability to Travel
• Bachelor’s Degree and/or 5-7 years Clinical Supplies Experience; majority in Clinical Supply Management at Sponsor Company.

Preferred:

• Clinical supply chain management at Sponsor company or Clinical Research Organization strongly preferred.
• Ability to work within the Client’s team structures and processes.
• Working knowledge of general project management process and tools.
• Ability to influence others, resolve conflicts, and negotiation skills.
• 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.
• Strong organizational skills.

Essential Duties and Responsibilities:

• Act as Client advocate, assisting with drug supply management throughout the life of the study.
• Work in an unblinded capacity with secure, confidential study information.
• Provide input for protocol development and amendment as needed.
• Interpret clinical protocol to determine drug and ancillary supply requirements.
• Coordinate with Client to generate Master English Label Text (MELT) if needed.
• Collaborate with Client and other appropriate stakeholders to establish labeling strategy.
• Build drug projections to create a Supply Plan based on finished goods demand.
• Collaborate with PCI Packaging Project Manager to establish a production schedule.
• Review and approve packaging batch documentation on behalf of blinded Client when requested.
• Support Interactive Response Technology (IRT) design, set up, and maintenance.
• Perform User Acceptance Testing (UAT) according to a testing protocol.
• Release drug supply in IRT system.
• Collaborate with Client to establish site supply parameters.
• Forecast clinical supply demand and manage clinical supply inventory throughout the clinical trial globally.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies.
• Attendance to work is an essential function of this position.
• Performs other duties as assigned by Manager.

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future.