What are the responsibilities and job description for the Clinical Supplies Project Manager II position at Actalent?
Description:
Responsible for the project management of key Clinical Supply Chain activities at the protocol level for Phase 1, 2, 3, 4 and IIS studies of increasing complexity 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 creating appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IVRS vendors, QA, clinical team partners etc to ensure timely availability of clinical supplies. 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 .
Skills:
Clinical Research, Clinical Supplies, Pharmaceutical, ICH, GCP, FDA, Clinical Trials, Protcol Development, Supply Chain, Investigational Drug, Clinical Operations
Top Skills Details:
Clinical Research,Clinical Supplies,Pharmaceutical
Additional Skills & Qualifications:
Bachelor’s Degree required preferably in physical/biological science, math, engineering or pharmacy. 5 years clinical supplies project management experience in the Pharmaceutical Industry.
Experience Level:
Entry Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
