Kelly Services CR22 - Clinical Research Coordinator I (CRC I) in San Francisco, California
Clinical Supply Manager (Pharmaceutical Product Development) San Francisco CA
Kelly Services is currently seeking a Clinical Supply Manager (Pharmaceutical Product Development) for one of our top clients San Francisco CA
Period 10/03/2017 to 03/31/2018
Hours per week: 40
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 Nektar’s 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 Nektar 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 to Nektar 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. Reviews IVRS specs and reviews IVRS user manuals; Designs, reviews and approves IP-related labels and study tools (for clinical study teams and investigative site use), as needed. Supports inspection team in preparation for and during regulatory agency inspection. Represents CSM on cross-functional study team (s) and/or sub-team(s); Effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful execution; Acts as point of escalation for IP-related issues. Leads management of IP service vendors (performance, quality, timelines, deliverables, costs); Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS); Provides input, reviews, and approves vendor study specifications; Serves as point of escalation for vendor-related IP issues as they arise; Reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated; Recommends vendors to CSM and Clinical Study Teams.
Bachelor’s degree and at least 8 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management. Experience developing trial drug supply plans; Investigational Product forecasting skills; Working knowledge of the clinical drug development process and clinical trial methodology; Knowledge of ICH/GCP and regulatory guidelines/directives; Leadership and negotiation skills; Ability to effectively multi-task and prioritize; Effective problem solving skills; Written and verbal communication and presentation skills; Project management and organizational skills; Computer skills, with competency in MS Word, Excel; Study Tools including electronic system skills IRT; Interpersonal skills; Cross functional and cross-cultural awareness; Ability to work in a matrix environment.
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group- rate insurance options available immediately upon hire*
*Available for purchase and administered by a designated third-party vendor
If you are interested in the position, please apply to this posting with an updated resume. Then follow up with a phone call to me, Dan Stubblefield, Kelly Services Scientific Recruiter, at firstname.lastname@example.org . Thank you for your time and I look forward to working with you.
Why Kelly ® ?
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 11,000 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.
AboutKelly 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 2016 was $5.3 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm