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CSL Behring CTS Study Manager (f/m/d) in Marburg, Germany

CTS Study Manager (f/m/d)GermanyR-0906911010 CSL Behring GmbH (DE)

Job Description

For our Functional Unit Clinical Trial Supply (CTS) Marburg or King of Prussia (U.S.A.) we are looking for a

CTS Study Manager (f/m/d) - R-090691

(fulltime/ permanent/ non-tariff) Expiration Date: 23.05.2019

Position Purpose:

The CTS Study Manager develops and implements 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.

The position holder has to ensure that the clinical study supply management follows global and local standard operating procedures, policies and national and international regulations.

Main Responsibilities and Accountabilities:

  • Planning, implementation and management of the logistics network for international clinical studies requiring a complex supply concept and in close collaboration with internal global specialty departments and external service providers.

  • Planning and implementation of the packaging design in compliance with country regulations and study specific requirements.

  • Development and maintenance of clinical supply material demand plans and adaptation to study specific needs.

  • Identification of quality standards and product specifications for all clinical supply materials in cooperation with global specialty departments.

  • Determination of product demands and coordination of the supply with the production departments at all CSLB manufacturing sites.

  • Sourcing of all non CSL Behring clinical supply materials within the required specification via international wholesalers, manufacturers or other service providers.

  • Development and maintenance of the logistics and product budget for clinical studies.

  • Coordination of a timely, high quality and on demand packaging and supply of all medicinal products and ancillary supplies.

  • Leading clinical supply meetings with internal and external specialty groups

  • Professional management of internal and external team members supporting supply management activities.

  • Generation or review of study documents relevant for regulatory submission (e.g. IMP handling instructions for investigators and study subjects, drug accountability forms, study protocol)

  • Preparation and conduct of trainings and presentations on international investigator meetings

  • Generation of documents for study sites enabling a GCP and GMP compliant documentation of handling and usage of the study medication as well as the regular review of the completed documentation

  • Training of external study monitors and internal global study teams in regards to study specific supply chain processes

  • Generation of final drug reconciliation reports for the entire clinical study

  • Visiting study sites to discuss options for the optimization of the study specific IMP supply and IMP documentation

  • Contribution to the selection of external service providers

  • Generation of study specific request for proposals and review of the quotes

  • Management of clinical manufacturing organizations (CMO) in regards to the contracted study and leading meetings with them

  • Processing of deviations reported from external service providers in compliance with company standards and existing quality agreements

  • Participation in business review meetings with external service providers

  • Review of study specific software specifications (IRT) to close cooperation with IT experts

  • Contribution to the development of test plans for software applications and participation in user acceptance tests

  • Maintenance of data in IRT systems and provision of status reports

  • Ensures that the internal systems (e.g. SAP, APO) contain the correct data

  • Generation and monitoring of the study specific logistics and product budget

  • Generation of study specific cost reports.

  • Monitoring of costs from external service providers according to the agreed upon budget targets

  • Preparation of inspections and audits regarding IMP supply related topics.

  • Participation in inspections and audits as IMP supply representative from the sponsor site

  • Timely processing and completion of audit and inspection findings

  • Generation of SOPs and other quality related documents

  • Participation as CTS representative in international study execution team Meetings

Position Qualifications and Experience Requirements:

  • A degree (BSc) or equivalent in life science, logistics or project management

  • Other degrees and certifications considered If commensurate with related clinical research or clinical supply management experience

  • Professional experience 5+ years with at least 3-4 years In clinical supply management or R&D project management

  • English Level 2

Competencies:

  • Very good understanding of clinical trial supply processes.

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

  • Very good knowledge of GMP and GDP regulations

  • Strong written and oral communication skills

  • Very good presentation skills

  • Strong organizational and time management skills

  • Ability to work in a matrix structure

  • Experiences in global project management

Marburg, 09.05.2019

CSL Behring GmbH, Human Resources

Expiration Date: 23.05.2019

Position Number: R-090691

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State/Province : Hesse

City : Marburg

Street Address : Emil-von-Behring-Stra├če 76

Primary Location : CSL Behring Marburg

Additional Location(s) : CSL Behring King of Prussia

Full Time/Part Time : Full Time

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click below.

CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement

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