PCI Pharma Services
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.
The Clinical Supply Manager (CSM) supports PCI Clinical Service Customers by bringing PCI's experience to clinical trial management, providing expertise throughout the clinical study supply lifecycle. The CSM acts as the customer's advocate within PCI and coordinates the necessary information between clinical functions, ensuring that clinical supplies are available in appropriate quantities where and when they are needed to support the clinical study.
Essential Duties and Responsibilities
Complete calculations to estimate clinical trial material demand and maintain the clinical supply inventory throughout the clinical trial.
Utilize simulation tools and supply chain expertise to determine packaging campaign and distribution strategies.
Execute UAT of the drug supply management modules in IRT systems.
Work with other project managers to ensure clinical supply depot set-up is complete and monitor depot inventory throughout study.
Manage clinical drug supplies, including packaging design and contingency planning
Work in an unblinded capacity with secure, confidential study information.
Participate any meetings necessary (i.e., CMC, CRO, Clin Ops, IRT, etc.) to help manage expectations and ensure clear communication.
Manage the SMART contract budget and initiate COs as needed.
Manage site inventories and request manual drug orders as needed.
Manage/monitor ancillary and comparator supplies inventories.
Provide final drug accountability reports to Clinical group.
Coordinate drug return, accountability, and destruction process.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attention to details is an essential function of this position
Performs other duties as assigned by Manager.
Work with Packaging Project managers to establish a production schedule based on the study supply plan.
Review and approve batch documentation.
Qualifications Required
Bachelor's Degree required
3-5 Years of Clinical Supplies Experience or Project Management experience
Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs, especially Microsoft Office.
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
Experience at a sponsor company is desired
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.
The base salary hiring range for this position is
($86,880 - $97,740) , with eligibility for an annual performance bonus. The final offer will be determined by a variety of factors, including but not limited to relevant experience, education, professional designations, specialized skills, and work location. This posting is for an existing vacancy currently open and available for hire.
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.
#J-18808-Ljbffr
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.
The Clinical Supply Manager (CSM) supports PCI Clinical Service Customers by bringing PCI's experience to clinical trial management, providing expertise throughout the clinical study supply lifecycle. The CSM acts as the customer's advocate within PCI and coordinates the necessary information between clinical functions, ensuring that clinical supplies are available in appropriate quantities where and when they are needed to support the clinical study.
Essential Duties and Responsibilities
Complete calculations to estimate clinical trial material demand and maintain the clinical supply inventory throughout the clinical trial.
Utilize simulation tools and supply chain expertise to determine packaging campaign and distribution strategies.
Execute UAT of the drug supply management modules in IRT systems.
Work with other project managers to ensure clinical supply depot set-up is complete and monitor depot inventory throughout study.
Manage clinical drug supplies, including packaging design and contingency planning
Work in an unblinded capacity with secure, confidential study information.
Participate any meetings necessary (i.e., CMC, CRO, Clin Ops, IRT, etc.) to help manage expectations and ensure clear communication.
Manage the SMART contract budget and initiate COs as needed.
Manage site inventories and request manual drug orders as needed.
Manage/monitor ancillary and comparator supplies inventories.
Provide final drug accountability reports to Clinical group.
Coordinate drug return, accountability, and destruction process.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attention to details is an essential function of this position
Performs other duties as assigned by Manager.
Work with Packaging Project managers to establish a production schedule based on the study supply plan.
Review and approve batch documentation.
Qualifications Required
Bachelor's Degree required
3-5 Years of Clinical Supplies Experience or Project Management experience
Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs, especially Microsoft Office.
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
Experience at a sponsor company is desired
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.
The base salary hiring range for this position is
($86,880 - $97,740) , with eligibility for an annual performance bonus. The final offer will be determined by a variety of factors, including but not limited to relevant experience, education, professional designations, specialized skills, and work location. This posting is for an existing vacancy currently open and available for hire.
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.
#J-18808-Ljbffr