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Clinical Project Manager I

In Illinois / United States

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Clinical Project Manager I   

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JOB TITLE:

Clinical Project Manager I

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

North Chicago Illinois / United States

JOB DESCRIPTION:

• Clinical Project Manager I (Non-MD)


o Education Requirement: Bachelor’s Degree required preferably in physical 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)
o Quality Assurance
o Major Responsibilities:
? Responsible for the project management of key Clinical Supply Chain activities at the protocol level for pre-clinical and Phase I – II 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.
o 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).

Position Details

POSTED:

Aug 02, 2021

EMPLOYMENT:

INDUSTRY:

Health Care

SNAPRECRUIT ID:

S162048616281310923

LOCATION:

Illinois / United States

CITY:

North Chicago

Job Origin:

Jobsrus_organic_feed

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In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Clinical Project Manager I    Apply

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• Clinical Project Manager I (Non-MD)


o Education Requirement: Bachelor’s Degree required preferably in physical 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)
o Quality Assurance
o Major Responsibilities:
? Responsible for the project management of key Clinical Supply Chain activities at the protocol level for pre-clinical and Phase I – II 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.
o 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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