Clinical Project Manager Ii (Non-Md)

Job Title: Clinical Project Manager II (Non-MD)

Type: Contract - 1 Year with Possible Extension

Pay: $72.95

Location: Remote

Day Shift

• Major 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

• 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).

– this manager wants to see DIRECT clinical supplies management experience.**

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

• Experience: 5+ years clinical supplies project management experience in the Pharmaceutical Industry.

Colorado, New York, MD, RI, CT, CA applicants:

Benefits include:

-MEC/ACP Medical

-Voluntary Dental, Vision, Life, Supplemental Income

-401k (must meet requirements)

-sick leave as required by state/county

Washington applicants: Employees (and their families) are covered by MEC/ACP medical, VOLUNTARY dental, VOLUNTARY vision, and VOLUNTARY basic life insurance. Employees are able to enroll in our company’s 401k plan, as well as a deferred compensation plan when employment requirements are met. Employees will also receive one hour of paid sick leave for every 40 hours worked per state guidelines and requirements.