SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

Manager, Clinical Supplies

Company: Cidara Therapeutics
Location: San Diego
Posted on: October 13, 2019

Job Description:

Position Summary Responsible for ensuring the clinical supplies required for assigned clinical studies are provided per the project timeline and in accordance with applicable regulatory requirements. This includes management and oversight of the planning, forecasting, sourcing, packaging, labeling, distribution and return of clinical supplies.  The successful applicant will collaborate closely as a member of cross-functional study teams that include Project Management, Clinical Operations, Regulatory and Quality. Reports to Director, Clinical Supplies. Responsibilities Develop study specific Global Product Supply Plans, contribute to Pharmacy Manuals and supply related training/instructional materials Manage supply planning/forecasting to ensure alignment with study activity and timelines Monitor inventory levels at sites through the life of a trial proactively avoiding potential issues Coordinate procurement, temperature excursions, product complaints and ensure expiry extensions are provided to depot/sites as needed to support continued use Collaborate with study team and vendors to assure proper distribution of supplies to study sites Manage return and destruction of clinical supplies, with proper documentation of all steps Serve as primary point of contact for third party packaging, distribution, and storage vendors Manage approval of the packaging and logistics service agreements and study specific plans Design/review/coordinate approval of investigational supply label text and proofs to meet specific country language(s), translations and regulatory requirements Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations (Qualified Person Release, Certificates of Analysis/Compliance, etc.) Work with cross-functional team to develop study-specific IXRS specifications and requirements documents providing IP management perspective Perform unblinded monitoring of IXRS inventory and functionality monitoring to assure resupply generation, etc. occur within defined specifications Minimum Qualifications Bachelor’s degree, preferably in a scientific discipline; a combination of relevant education and applicable job experience may be considered. 5+ years global clinical supplies experience Thorough knowledge of GMPs, GCPs, ICH Guidelines Experience with IRT System design, implementation, user testing and monitoring Vendor management experience Ability to establish and meet multiple concurrent priorities and deadlines Willingness and ability to travel domestically and internationally as needed (~10%) Effective organizational skills, verbal and written communication, ability to present in group settings, commitment to quality, and the ability to think critically and creatively The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs. Cidara Therapeutics is an E-Verify Company

Keywords: Cidara Therapeutics, San Diego , Manager, Clinical Supplies, Other , San Diego, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Medical Transcriptionist - Multi-specialty
Description: Recent MT graduates are welcome to apply. This is an immediate fill for the right person to work remotely. We are located in Edmond, OK and we are seeking an additional 9 remote transcribers to join our (more...)
Company: Mommy Jobs Online
Location: El Centro
Posted on: 10/16/2019

Truck Driver Class A CDL Recent Grads – Better Pay!
Description: Recent CDL-A Grads: Don't have enough experience to get the truck driving job you want No worries, come join us You will spend 165 hours behind the wheel with
Company: C.R. England
Location: Placentia
Posted on: 10/16/2019

Truck Driver Class A CDL Recent Grads – Better Pay!
Description: Recent CDL-A Grads: Don't have enough experience to get the truck driving job you want No worries, come join us You will spend 165 hours behind the wheel with
Company: C.R. England
Location: Palm Desert
Posted on: 10/16/2019


Part Time Brand Ambassador_TY
Description: Part Time Brand Ambassador TY At our Company, we grow People, Brands, and Businesses We are hiring enthusiastic, self-driven Part Time Brand Ambassadors to promote leading products through in-store sales (more...)
Company: Advantage Solutions
Location: Lake Elsinore
Posted on: 10/16/2019

Truck Driver Class A CDL Recent Grads – Better Pay!
Description: Recent CDL-A Grads: Don't have enough experience to get the truck driving job you want No worries, come join us You will spend 165 hours behind the wheel with
Company: C.R. England
Location: Lake Elsinore
Posted on: 10/16/2019

Truck Driver Class A CDL Recent Grads – Better Pay!
Description: Recent CDL-A Grads: Don't have enough experience to get the truck driving job you want No worries, come join us You will spend 165 hours behind the wheel with
Company: C.R. England
Location: La Quinta
Posted on: 10/16/2019

Recent Grad CDL-A Truck Driver – Earn More!
Description: Recent CDL-A Grads: Don't have enough experience to get the truck driving job you want No worries, come join us You will spend 165 hours behind the wheel with
Company: C.R. England
Location: Yucaipa
Posted on: 10/16/2019

Recent Grad CDL-A Truck Driver – Earn More!
Description: Recent CDL-A Grads: Don't have enough experience to get the truck driving job you want No worries, come join us You will spend 165 hours behind the wheel with
Company: C.R. England
Location: La Quinta
Posted on: 10/16/2019

Email Marketing Processor- (Flexible Schedule)
Description: Mommy Jobs Online is now recruiting Email Marketing Processors to work remotely. Great opportunity for the perfect person that has a home office setup to work remotely. At Mommy Jobs Online our qualified (more...)
Company: Mommy Jobs Online
Location: El Centro
Posted on: 10/16/2019

Recent Grad CDL-A Truck Driver – Earn More!
Description: Recent CDL-A Grads: Don't have enough experience to get the truck driving job you want No worries, come join us You will spend 165 hours behind the wheel with
Company: C.R. England
Location: Palm Desert
Posted on: 10/16/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Diego RSS job feeds