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Evidence Generation Manager

Zurich, Switzerland

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

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    Procurement Lead, Northern Europe

    Anders Tellefsen
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  • Yves Leurquin

    Regional Head, Europe, Vaccines

    Susan Tillman
    “Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”

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Evidence Generation Manager

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Job ID R0007041 Date posted 02/05/2019 Location Zurich, Switzerland

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Job Description

The Evidence Generation Manager belongs to the Global Medical Office in the Vaccine Business Unit and will be the Operational Responsible for

  • the oversight of the execution of Medical Affairs Vaccine Research including Health Outcomes Vaccine Research studies of assigned Vaccine Evidence Generation plan in compliance with quality standards ( including ICH GCP, international standards, local regulations and Takeda SOPs), on schedule and budget
  • the oversight of strategic partners and / or the CROs and other third party vendors to meet Takeda`s obligations described in Policies and SOPs and VBU business objectives.

The assigned Medical Affairs Vaccine Research studies may be high complex e.g. interim analyses, end point review committees, requiring coordination of multiple vendors and other special assessments. More than one study and/or more than one vaccine program can be assigned.

Medical Affairs Vaccine Research studies include post-and pre-licensure investigator initiated studies, collaborative clinical research studies, health outcomes studies, epidemiology studies and company sponsored non-registration studies.

The Evidence Generation Manager will work closely with the Evidence Generation Lead, Global Medical Strategy Team (GMST), Development Delivery, and the Epidemiology team. The Evidence Generation Manager reports into the Head of GMO Operations.

  • Accountable for planning and operational execution for assigned Medical Affairs Vaccine Research studies
    • Provides operational subject matter expertise into synopsis and final protocol document
    • Challenges to ensure operational feasibility, inclusive of subject and site burden
    • Validates budget and ensures impacts are adequately addressed
    • Participates in country and site selection process as needed and with a focus on corporate alignment and operational expertise to ensure alignment between study execution and Vaccine Evidence Generation plan
    • Ensure timelines meet the needs of the Vaccine Evidence Generation plan, that accurate assumptions are applied and robust risk management plans are in place
  • Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation
  • Responsible for study budget planning and management and accountable for external spend related to study execution 
  • Provide support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
  • Serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs
  • Works closely with Evidence Generation Lead, the Development Delivery Team, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate
  • Communicates study status, cost and issues to the Evidence Generation Lead, GMST (Global Medical Strategy Team), Head of GMO Operations and other relevant stakeholders
  • Supports specific areas of sponsor oversight include, but are not limited to:
    • Review and approval of risk management plans, periodic review of outputs, decisions and actions related to risk based monitoring of Medical Affairs Vaccine Research studies including escalation of issues to governance committees when warranted
    • Review and endorsement of Data Management Strategy and Operational Plan, a document which focuses on data concepts and data management principles at study level
    • Review of outcomes/actions related to deviations in order to support the identification of trends across sites and/or the study

In partnership with data management of the Strategic partners/CRO, review and pressure test all database timelines and plans to ensure strong linkage between the Evidence Generation plan with the tactical plan for database lock and study report / publication.

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0007041

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