Kelly Scientific Resources is a specialty service of Kelly Services®. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines. Our scientists contribute to the research and development of therapeutics that change the lives of those affected with disease. We have an exciting contract opportunity in the San Francisco Area for a Clinical Supply Manager.
Clinical Supply Manager
The Manager, Clinical Supply Management is responsible for forecasting Investigational Product IP supply requirements for multiple clinical trials and for managing the IP distribution process to one or more clinical trials.
Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities regulations / guidelines and SOPs. Contributes to ongoing process improvement initiatives.
This role applies to internally sourced studies and/or CRO/Partnered studies.
Collaborates and interacts with clinical trial managers, therapeutic area project managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, CMC, external manufacturing, and stability.
Effectively meets the customer expectations in the delivery of CSM to support the key Clinical milestones for study starts and patient resupply.
Supply Planning: Serves as lead logistics manager for the functional area in supply planning, including demand forecasting.
Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan; Works with CSM management to determine resourcing needs; Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals; Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines; Oversees setup and management of IVRS IWRS Manages and tracks investigational product IP inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends by performing routine forecasting / demand planning.
Oversees IP shipment orders according to supply plans to ensure timely and compliant shipment and delivery to investigator sites from order request thru acknowledgement of receipt by the clinical site.
IVRS: Working knowledge and experience with Interactive Response Technologies IRT; Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors.
Lead effort for clinical supply management functionality; Monitor and manage clinical supply activities through IRT from study start-up through study closure; Ensure appropriate system documentation is transferred for TMF and inspection readiness.
Reviews and evaluates temperature excursion data by following relevant SOP; provides assessments to supply management team regarding excursion trends in each study. Reviews drug return and destruction records; communicates with investigator sites, CROs and external vendors to resolve issues.
Performs 100 drug accountability from bulk drug, production, distribution, and returns / destruction. Monitors IP expiry data and informs CSM and CMC teams of pending IP expiry needs.
Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors.
Ensures appropriate documentation of IP supply activities is provided for the Trial Master File
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
About Kelly Services®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.