Job description

Responsibilities:

• 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

Requirements:

• Bachelors degree required, Masters degree and or PMP certification preferred

• 3+ years minimum clinical supplies project management experience in the pharmaceutical industry (5+ years exp highly preferred)

• 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 manage and prioritize multiple tasks with good communication skills (both written and oral).

Collaborative Technologies is proud to be an Equal Opportunity Employer.

Job Types: Full-time, Contract

Pay: $70.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Clinical Supply Chain: 3 years (Preferred)
• Project management: 3 years (Preferred)
• Pharmaceutical Industry: 1 year (Required)

Work Location: Remote

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