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Clinical Trial Supply Study Manager at Advanced Clinical

Posted in Other 30+ days ago.

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Type: Full Time
Location: King of Prussia, Pennsylvania





Job Description:

OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as Clinical Trial Supply Study Manager in King of Prussia, Pennsylvania. The Clinical Trial Supply Study Manager role will develop and implement the logistics network for global clinical studies with a complex study design and in close cooperation with other internal specialty departments and external service providers. Their work will have a direct impact on not just the organization but also on the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

* Plan and implement the packaging design in compliance with country regulations and study specific requirements

* Develop and maintain clinical supply material demand plans and adapt to study specific needs

* Identify quality standards and product specifications for all clinical supply materials in cooperation with global specialty departments

* Determine product demands and coordinate the supply with the production departments at manufacturing sites

* Source all non-clinical supply materials within the required specification via international wholesalers, manufacturers, or other service providers

* Maintain the logistics and product budget for clinical studies

* Coordinate all medicinal products and ancillary supplies

* Lead clinical supply meetings with internal and external specialty groups

* Review study documents relevant for regulatory submission

* Prepare and conduct trainings and presentations at international investigator meetings

* Generate documents for study sites

* Train external study monitors and internal global study teams in regards on study specific supply chain processes

* Produce final drug reconciliation reports for the entire clinical study

* Visit study sites to discuss options for the optimization of the study specific IMP supply and IMP documentation

* Contribute to the selection of external service providers

* Create study specific request for proposals and review of the quotes

* Manage CMO involved in the contracted study and lead meetings with them

* Process deviations reported from external service providers in compliance with company standards and existing quality agreements

* Review study specific software specifications (IRT) with IT experts

* Maintain data in IRT systems, create status reports, and ensure internal systems contain the correct data

* Monitor costs from external service providers according to the agreed upon budget targets

* Prepare inspections and audits regarding IMP supply related topics

* Participate in inspections and audits as IMP supply representative from the sponsor site

* Complete audit and inspection findings timely

* Assist in generating SOPs and other quality related documents

EXPERIENCE

* Minimum of 5 years of professional experience required, with at least 3 years in clinical supply management or R&D project management

* Good understanding of clinical trial supply processes

* Strong knowledge of ICH-GCP regulations and the conduct of clinical studies

* Excellent knowledge of GMP and GDP regulations

* Strong written, oral, and presentation skills

* Experience in global project management

* Demonstrated experience in clinical trial supply leading multiple clinical studies and projects (from phase I to phase IV), from a sponsor perspective

* Fluent in German desired

EDUCATION

* Minimum of Bachelor's Degree in life science, logistics, or project management required

To be a best-fit your strengths must include

* Strong Communicator

* Organized

* Ability to work indepenently and with a team

* Problem-Solver

* Personable

* Credible

About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.