Clinical Trial Supply Study Manager/Sr. Study Manager at CSL Limited in King Of Prussia, PA
Main Responsibilities and Accountabilities:
Establishes and oversees the creation and execution of multi-year clinical supply strategies and plans for assigned clinical studies. Develops long-term clinical supply forecasts to support company planning processes. Ensures alignment of these plans with the multidisciplinary Core Project Teams and Clinical Development Teams, as well as with Commercial, Operations and Global Supply Planning. Manages a team of CTS Study Managers and/or CTS Study Specialists to supply large and/or complex clinical studies with drug and ancillary materials. Hires staff with concurrence of CTS leadership. Manages performance and career development of team members. Mentors junior staff. Represents CTS in Clinical Development Teams and Study Execution Teams. Reviews study protocols and provides clinical supply input. Determines clinical kit design based on protocol needs. Plans and forecasts product volume requirements for assigned global clinical programs based on clinical study assumptions. Establishes global network of regional and local depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies. Manages timely and compliant importation of drug supplies and ancillary supplies into regional and local depots. Ensures on time delivery of drug supplies and ancillary supplies from depots to clinical sites and/or patients. Develops clinical trial supply documentation and training to support study execution for clinical sites and patients (e.g. Investigational Medicinal Product Handling Manuals, product reconstitution videos). Presents clinical supply plans, approaches and logistics at international investigator meetings. Utilizes Interactive Response Technology (IRT) systems to ensure reliable and efficient clinical supply to depots and sites. Adjusts system settings based on study progress and changes to clinical and/or supply assumptions. Selects and manages external service providers for effective study execution (i.e. packaging, labeling, storage, import/export, distribution, ancillary supplies, comparators, rescue medication) in collaboration with Vendor Management and Global Sourcing. Ensures compliance of all clinical study activities with SOPs and regulations for assigned studies. Participates in audits and regulatory inspections as needed. Responsible for ensuring proper documentation is completed and filed throughout the study and after study closure. Investigates deviations, product technical complaints and temperature excursions. Develops global and harmonized SOPs to assure ongoing quality, compliance and efficient conduct of clinical supply activities. Creates and updates budgets for assigned clinical studies. Independently leads cross-functional process improvement projects for the clinical supply chain. Position Qualifications and Experience Requirements University degree (BSc, MSc, PhD) in life sciences, engineering, logistics or equivalent experience Minimum of 7 years' experience in clinical supply management, clinical research, product development and/or global R&D project management in the biopharmaceutical industry 3 years' experience in clinical trial supplies, leading global studies
Salary Range:
$100K -- $150K
Minimum Qualification
Supply Chain & Logistics, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Establishes and oversees the creation and execution of multi-year clinical supply strategies and plans for assigned clinical studies. Develops long-term clinical supply forecasts to support company planning processes. Ensures alignment of these plans with the multidisciplinary Core Project Teams and Clinical Development Teams, as well as with Commercial, Operations and Global Supply Planning. Manages a team of CTS Study Managers and/or CTS Study Specialists to supply large and/or complex clinical studies with drug and ancillary materials. Hires staff with concurrence of CTS leadership. Manages performance and career development of team members. Mentors junior staff. Represents CTS in Clinical Development Teams and Study Execution Teams. Reviews study protocols and provides clinical supply input. Determines clinical kit design based on protocol needs. Plans and forecasts product volume requirements for assigned global clinical programs based on clinical study assumptions. Establishes global network of regional and local depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies. Manages timely and compliant importation of drug supplies and ancillary supplies into regional and local depots. Ensures on time delivery of drug supplies and ancillary supplies from depots to clinical sites and/or patients. Develops clinical trial supply documentation and training to support study execution for clinical sites and patients (e.g. Investigational Medicinal Product Handling Manuals, product reconstitution videos). Presents clinical supply plans, approaches and logistics at international investigator meetings. Utilizes Interactive Response Technology (IRT) systems to ensure reliable and efficient clinical supply to depots and sites. Adjusts system settings based on study progress and changes to clinical and/or supply assumptions. Selects and manages external service providers for effective study execution (i.e. packaging, labeling, storage, import/export, distribution, ancillary supplies, comparators, rescue medication) in collaboration with Vendor Management and Global Sourcing. Ensures compliance of all clinical study activities with SOPs and regulations for assigned studies. Participates in audits and regulatory inspections as needed. Responsible for ensuring proper documentation is completed and filed throughout the study and after study closure. Investigates deviations, product technical complaints and temperature excursions. Develops global and harmonized SOPs to assure ongoing quality, compliance and efficient conduct of clinical supply activities. Creates and updates budgets for assigned clinical studies. Independently leads cross-functional process improvement projects for the clinical supply chain. Position Qualifications and Experience Requirements University degree (BSc, MSc, PhD) in life sciences, engineering, logistics or equivalent experience Minimum of 7 years' experience in clinical supply management, clinical research, product development and/or global R&D project management in the biopharmaceutical industry 3 years' experience in clinical trial supplies, leading global studies
Salary Range:
$100K -- $150K
Minimum Qualification
Supply Chain & Logistics, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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