Clinical Project Manager

3 weeks ago


San Diego, United States SPECTRAFORCE Full time

Job Title: Clinical Project Manager

Location: Lake County IL 60064

Duration: 12 Months

Summary:

• Education Requirement: Bachelor’s Degree required preferably in physical/biological science, math, engineering or pharmacy.

• 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

• Major 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



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