Full-Time Senior Project Manager, Clinical Supply

Purpose: Forecasts, plans, schedules, coordinates, and executes, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots. Manages key Clinical Supply Chain projects and activities at the protocol level for Phase I-IV clinical trials of increasing complexity. Works under the supervision of Program Manager or Associate Director and directly with mentor.

Responsibilities:

• 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 IRT vendors, quality assurance, 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.
• Participates in cross-functional initiatives as drug subject matter expert.
• Leads in function improvement initiatives.

Qualifications:

• Bachelor’s Degree required, preferably in physical science, math, engineering, or pharmacy.
• 3 years total experience in Pharmaceutical industry preferred, but not required.
• Must have experience in one of the following areas: Drug Discovery (e.g. Process Chemistry, Analytical Chemistry), Drug Development (e.g. formulation), Clinical Operations (e.g. Clinical Project Management), Supply Chain (e.g. Clinical Supplies Project Management), Quality Assurance.
• Proficient in the application of standard business requirements (for example SOPs, Global Regulations, 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 representing CDSM as participant in and contributor to cross-functional initiatives.
• Ability to work collaboratively across departments/functions and interact in a tactful, professional, and effective manner.
• Ability to manage and prioritize multiple tasks under tight deadlines and high pressure.
• Strong problem-solving and Project Management skills.
• Strong communication skills (both written and oral).

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