Senior Project Manager, Clinical Supply

Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient ulizaon of supply chain resources. Translates clinical study design into packaging design. Authors the study medicaon and labeling secon of the clinical protocol. Develops protocol specific labeling compliant with applicable global regulaons. Idenfies, develops, communicates and tracks project melines, acvies, logiscs and milestones. Responsible for creang appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IRT vendors, quality assurance, clinical team partners, etc. to ensure mely availability of clinical supplies. Responsible for protocol specific clinical supplies scenario analysis, risk management and conngency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodies, including overages. Parcipates in cross funconal iniaves as drug subject maer expert. Leads in funcon improvement iniaves.
Bachelor’s Degree required, preferably in physical science, math, engineering or pharmacy. 3 years total experience in Pharmaceucal industry preferred, but not required. Must have experience in one of the following areas: Drug Discovery (e.g. Process Chemistry, Analycal Chemistry), Drug Development (e.g. formulaon), Clinical Operaons (e.g. Clinical Project Management), Supply Chain (e.g. Clinical Supplies Project Management), Quality Assurance. Proficient in the applicaon of standard business requirements (for example SOPs, Global Regulaons, OEC,). Must have understanding of importance of compliance in a regulated environment and be capable of applying this knowledge to improve current processes. Capable of represenng CDSM as parcipant in and contributor to cross funconal iniaves. Ability to work collaboravely across departments/funcons and interact in a tacul, professional and effecve manner. Ability to manage and priorize mulple tasks under ght deadlines and high pressure. Strong problem solving and Project Management skills. Strong communicaon skills (both wrien and oral).

Employment type
Full-time

Work arrangement
Yes