Clinical Supplies Manager II

Clinical Supplies Manager II page is loaded## Clinical Supplies Manager II locations:
Alameda, CAtime type:
Full time posted on:
Posted 2 Days Agojob requisition :
JR6353
** SUMMARY/

JOB PURPOSE:

** The Clinical Supplies Manager II oversees all aspects of clinical supply management including packaging, labeling, monitor inventory levels, and distribution by interacting with internal and external supply partners/vendors to ensure supply of IMP are sufficient at depots and clinical sites.
*
* Essential Duties And Responsibilities:

*** Lead effort for clinical supply management functionality.
* Monitor and manage clinical supply activities through IRT from study start-up through study closure.
* Proactively drive the labeling, packaging, release, distribution of clinical supplies at external CMO’s for assigned studies, ensuring the project timeline is met or exceeded.
* Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following availability of technical and regulatory releases.
* In collaboration with relevant partners, create forecasts and packaging design based on study needs to ensure optimized supply plan.
* Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are labelled and released for clinical site shipment for global clinical trials.
* Work cross-functionally to develop IRT to develop specifications and perform UAT.
* Design and/or review label text to meet product requirements and ensure compliance with US and international regulations.
* Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners.
* Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors.
* Ensure appropriate system documentation is transferred to TMF and ready for inspection readiness.
* Utilize appropriate software and IT systems to effectively manage key project activities.
*
* Supervisory Responsibilities:

*** None
* * EDUCATION/EXPERIENCE/KNOWLEDGE &

SKILLS:

**** Education/

Experience:

*** BS/BA degree in related discipline and a minimum of seven years of related experience; or,
* MS/MA degree in related discipline and a minimum of five years of related experience; or,
* Equivalent combination of education and experience.
* Certification in assigned areas is a plus.
** Experience/The Ideal for Successful Entry into Job:
*** Demonstrated experience with clinical supply management planning, labeling, packaging, and distribution.
* Clinical Supply management experience using contract manufacturing companies strongly preferred.
* Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS
** Knowledge/

Skills:

*** Willingness to work in a fast paced, evolving environment.
* Knowledge of GMP batch record development, review, and approval processes.
* Knowledge of Interactive Voice/Web response systems for use in clinical studies.
* Working knowledge of regulations relating to clinical labeling, packaging and distribution activities.
* Working knowledge of GMP/GCP/GLP regulations required.
* Excellent project management and communication skills.
** JOB COMPLEXITY:
*** Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
* Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways.
* May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
* Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
* Networks with key contacts outside own area of expertise.
*
* Working Conditions:

*** 20% travel to vendor sites, team meetings, and/or other offices.#LI-MB1
* If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!*### ### Our compensation reflects the cost of labor across several

U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $121,500 -…