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CTSU Project Manager

Location
Connecticut
Job Type
Permanent
Posted
21 Jul 2022

Description:

Description\:

 

 

Oversees the global clinical supply activities and manages proactively bulk availability and flow of information within assigned BI development projects.

 

 

Responsible for the evaluation and forecasting of bulk drug product and comparator needs of global phase I - IV projects. Provides IMP supply chain strategies and ensures as primary point of contact global cross-functional collaboration and communication to Medical and R&D Subteams as well as to bulk manufacturing units and other interfaces such as Global Sourcing and Logistics.

 

 

Responsible for managing global Supply Chain activities in support of national and international phase I - IV clinical trials, including Investigator Initiated Studies (IIS).  Ensures the timely provision of clinical supplies for assigned trials. Responsible leader of the CTSU trial team within the matrix structure, ensuring international cross-functional collaboration, and developing interfaces for all Supply Chain activities on the basis of business, regulatory and industry need.  Ensures that all work is performed in a safe manner, and in conformance with US, EU, and German regulations.

 

 

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

 

 

Duties & Responsibilities\:

 

  • Represents CTSU as primary point of contact and Subteam Member for assigned projects at Medical and R&D Subteam meetings, as well as at other relevant meetings and committees, to facilitate the Supply Chain process and to report clinical supplies situation.

  • Provides advice, challenges and negotiates supply chain strategies (i.e. use of IRT systems, packaging and distribution strategies, randomization and blinding strategies, fill count standardization) to optimize IMP supply and usage within a project.

  • Collaborates with Team Member Medicine, reviews and provides input into core clinical study protocols to determine supply requirements.

  • Establishes project timelines and tracks key milestone dates (i.e. drug product availability, final release), and provides risk analysis to Clinical Development when milestone dates are not met, or late stage changes are proposed.

  • Initiates prioritization requests within a project

  • Provides project information for updates of the Global CTSU

  • Provides information to CTSU forecasting/planning tool (GTL).

  • Interfaces with TM R&D and TMM on bulk manufacturing schemes, options and scenarios, based on API availability and Bulk Requests.

  • Interacts with CTSU Trial Managers to track trial specific bulk needs

  • Provides rolling forecasts for bulk drug products to manufacturing units.

  • Supports the identification and drives evaluation of suitability of comparator products on project level (as communicated at SoD or by MST), including the establishment of timelines, researching product availability, communicating regulatory/legal issues, etc.

  • Establishes and maintains IMP preparation (project) plans continuously, comprising all relevant work packages.

  • Continued management of trial supplies through to study completion, including overseeing the feasibility of expiry date extensions and resupply needs.

  • Drives the Key Data Sheet process, generates English Master Label Text, establishes trial timelines and tracks key milestone dates (i.e. Drug Supply Meetings, completion of appropriate orders), and provides risk analysis to Clinical Operations when milestone dates are not met, or late stage changes are proposed.

  • Leads the CTSU trial team for planning, coordination, and execution of Supply Chain activities to ensure all relevant trial activities (i.e. bulk drug orders, batch documentation, label text approvals, packaging & labeling, final release, cost estimates, distribution summary, monitoring of shipments, IRT etc.) are completed by their defined due dates, and provides support with these activities, as needed.

  • Updates regularly the cost estimate file and provides drug product and comparator cost information in support of the Medical budget for assigned projects and trials.

  • Time-close update in case of significant changes. Regular check of actual costs versus planned costs and adjustment of deviations including tracking of the source for the deviation.

  • Provides problem solving solutions using creative /innovative thought and technology, to support the successful completion of supply chain activities.

  • Promotes and implements new systems, methods, techniques and work modes to augment the supply chain process.

  • Supports generation of regulatory documents for submission, such as P210.

 

Requirements

 

  • Master's Degree from an accredited institution and six-plus (6+) years experiences in a related scientific discipline or Bachelor's Degree from an accredited institution with ten-plus (10+) years in a related field of equivalent experience in a related field

  • Demonstrates knowledge of all areas of clinical supply chain activities and a thorough knowledge and understanding of applicable US and EU regulations.

  • Ability to learn new technologies and concepts to enhance operations.

  • Strong computer skills (e.g. Microsoft Office).

  • Solid project management skills.

  • Communicates effectively orally and in writing. Proven ability to present projects / status reports to different audiences.

  • Ability to interpret standard and complex project requirements.

  • Strong problem solving, risk assessment and troubleshooting skills.

  • Proven ability to drive results in a changing environment.

  • Good knowledge and understanding of applicable regulations.

  • Excellent presentation skills.

  • Willingness to travel.

  • Ability to effectively lead, direct and motivate teams.

  • Ability to prepare and justify new concepts and initiatives to enhance operations within Global CTSU.

  • Excellent individual time management.

  • Ability to prioritize daily tasks and to handle challenging and stressful daily business.

  • Fluency in both English and German

 

 

Eligibility Requirements\:

 

Must be legally authorized to work in the United States without restriction.

Must be willing to take a drug test and post-offer physical (if required)

Must be 18 years of age or older

 

 

Who We Are\:

 

At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more?  Visit and join us in our effort to make more health.

 

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

 

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Details

  • Job Reference: 663059429-2
  • Date Posted: 21 July 2022
  • Recruiter: Boehringer Ingelheim
  • Location: Connecticut
  • Salary: On Application
  • Sector: Administration
  • Job Type: Permanent