Job Description: • Responsible for the project management of key Clinical Supply Chain activities at the protocol level for and Phase I - IV clinical trials • Includes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots. • Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources. • Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol. • Develops protocol specific labeling compliant with applicable global regulations. • Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones. • Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning.
Responsibilities: • Responsible for the project management of key Clinical Supply Chain activities at the protocol level for and Phase I - IV clinical trials • Includes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots. • Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources. • Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol. • Develops protocol specific labeling compliant with applicable global regulations. • Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones. • Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overages. • Critical Success Factors • Understanding of clinical development and global supply chain requirements. • Competent in the application of standard business requirements (for example SOPs, Global Regulations). • Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work. • Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner. • Ability to work effectively and professionally with those in the dept as well as Clinical, QA, Analytical and any area interface. • Ability to manage and prioritize multiple tasks. • Project Management skills. • Good communication skills (both written and oral).
Experience:
2+ years total experience in the Pharmaceutical Industry. Preferably experience in one of the following areas: • Drug discovery (eg, Process Chemistry, Analytical Chemistry) • Drug development (eg, Formulation) • Clinical operations (eg, Clinical Project Management) • Supply chain (eg, Clinical Supplies Project Management) • Quality Assurance
Skills:
Clinical Supply Chain, clinical protocol, drug supply, IRT, project management & Drug packaging.
Education:
Bachelor's Degree required preferably in physical/biological science, math, engineering or pharmacy.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.