Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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.
This is a FULLY REMOTE opportunity:
Summary of Objective:
The SMART Services Senior Clinical Supply Manager (CSM) 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, Compassionate Use, international to domestic, and all levels of trial and supply chain complexity. The Senior CSM role supports PCI Clinical Service Customers by bringing clinical supply chain management experience and providing expertise throughout the clinical study and program supply lifecycle. The Senior CSM can act as the Client’s single point of contact in coordinating the necessary information cross-functionally within PCI as well as the Client's organization and other external vendors.
Essential Duties & 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, packaging / labeling design, and supply plan
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 and production plans for domestic and international studies, considering drug retest and expiration dating
Collaborate with PCI Packaging Project Manager (PM) to establish a production schedule based on the study supply plan
Review and approve packaging batch documentation (pre and post production) on behalf of blinded Client when requested
Contribute to commercial comparator sourcing strategy when needed
Support Interactive Response Technology (IRT) design, set up, and maintenance
Participate in IRT Requirements gathering process and provide input for IRT specification documents
Perform User Acceptance Testing (UAT) according to a testing protocol (if provided), with focus on functionality, transactions, and reports that relate to drug supply management
Release drug supply in IRT system
Collaborate with Client to establish site supply parameters
Adjust re-supply strategies by assessing clinical protocol revisions and analyzing enrollment rates, inventory usage, and trends
Consult with PCI Distribution Project Manager (DPM) to ensure depot strategy, logistics management documentation, and setup is complete and meets Client requirements
Assist with Import / Export process
Assist with Quality processes (e.g., gathering documentation for EU Qualified Person)
Independently manage clinical supplies, including packaging design, and contingency planning for multiple and complex studies
Identify, manage, and monitor inventory of all clinical trial materials (drug and ancillary supplies) at both the depot and site level
Track shipments to depots and sites
Proactively identify potential risks, provide recommendations, and resolve clinical supply issues and complaints
Adjudicate temperature excursions when requested by Client
Manage and track the SMART contract budget and initiate Change Orders as needed
Provide information as requested to support Client financial planning for global studies
Attend Client meetings as requested (e.g., CMC, CRO, Clinical Operations, IRT, etc.) to provide updates for clinical supply, proactively manage expectations regarding drug delivery timelines and ensure clear cross-functional communication
Coordinate drug return, accountability, and destruction process
Provide final drug accountability reports to Client
This position may require extra hours 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/Supervisor.
Qualifications:
Required:
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 asks 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:
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 multi-task
Strong organizational skills
The hiring rate for this position is $122,000-$137,250 plus eligibility for an 15% annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
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.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
