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    Senior Manager, Clinical Trial Tools & Technologies

    Takeda Pharmaceutical
    6+ years
    133,000.00 - 209,000.00
    Remote
    10 Dec. 31, 2024
    Job Description
    Job Type: Full Time Education: BS/BA Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    The Senior Manager, Clinical Trial Tools & Technologies position at Takeda is a remote role within the company's Global Development Organization (GDO). The GDO is dedicated to advancing clinical trial innovation, clinical supply chains, and patient safety, leveraging technology to enhance the predictability, speed, and quality of clinical development. Below is a detailed summary of the role:

    Key Responsibilities:

    1. Technology Deployment & Strategy:

      • Develop strategies for selecting and deploying technologies across clinical studies, ensuring alignment with Takeda’s Standard Operating Procedures (SOPs), policies, and governance models.
      • Manage the system delivery lifecycle, including deployment strategies, user training, and ongoing management.

    2. Business Change Management:

      • Serve as the primary business change agent to drive the adoption of new technologies and business processes.
      • Lead the deployment of clinical trial technologies such as eCOA (electronic Clinical Outcome Assessments), IRT (Interactive Response Technology), eConsent, telehealth, medical devices, and COA (Clinical Outcome Assessments) instrument licensing.

    3. Vendor Oversight & Collaboration:

      • Serve as the main point of contact for clinical technology vendors, ensuring that milestones and deliverables are met with the highest quality standards.
      • Lead study-level technology and vendor oversight activities, working with stakeholders to resolve issues impacting clinical trial delivery.

    4. Regulatory & Inspection Readiness:

      • Ensure the archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents.
      • Support preparation for submission readiness and represent the Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits.

    5. Operational Process Expertise:

      • Act as a process expert for operational and oversight models, guiding the implementation of clinical technologies within study teams.
      • Collaborate with internal teams (e.g., Clinical Operations, IT, Clinical Supplies, Quality) to ensure smooth technology adoption and integration into clinical trials.

    Education & Experience:

    • Education:
      • BS/BA in health-related, life sciences, or technology-related fields is required; MS is preferred.
    • Experience:
      • 6+ years in drug development or clinical trials.
      • Experience in managing the implementation of clinical technologies such as eCOA, IRT, EDC (electronic data capture), medical devices, or clinical data warehousing for large-scale drug development programs.
      • Familiarity with FDA and ICH regulations and industry standards.
      • Proficiency in System Development Life Cycle (SDLC) and knowledge of evolving GXP regulations impacting clinical trial technologies.
      • Ability to identify new technology trends to improve clinical trial processes.
      • Experience in all phases of drug development.
    • Additional Skills:
      • Strong project management skills and experience managing integrations or implementations of clinical technologies.
      • High complexity program management, potentially involving multiple projects or platforms.
      • Domestic/international travel (5-20%) may be required for site visits, partner engagements, and events.

    Compensation and Benefits:

    • Salary Range: $133,000 - $209,000 (based on experience and qualifications).
    • Benefits:
      • Medical, dental, and vision insurance.
      • 401(k) plan with company match.
      • Short-term and long-term disability coverage.
      • Paid sick time, vacation, and holidays.
      • Tuition reimbursement and wellness benefits.

    About Takeda:

    Takeda is a global leader in R&D-driven pharmaceuticals, focusing on delivering transformative therapies for patients. The company is committed to fostering an inclusive, diverse, and collaborative workplace, and its mission is to improve patient outcomes through innovation.

    This position offers an exciting opportunity to play a pivotal role in advancing clinical trial technologies, supporting Takeda’s clinical research efforts, and impacting patient care globally.

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    Warsaw |

    Remote :

    Thailand | Slovakia | Texas | Remote | Remote, USA | Lousiana | Zaragoza | Hammond | Medan | Melbourne | Tulsa | Springville | Nairobi | Xzagreb | Blue Bell | Leinster | Remote - South America (Latin Americal) | French | Ireland | Hungary | McFarland | Lenexa | Victoria | Castlebar | Bountiful | Switzerland | Belgium | Bishop | Remote - Europe | Manipal | Remote - Middle East | Green Way | Faridabad | Minnesota | Riga | Remote - Africa |

    Bucharest :

    Bucharest |

    Makkah :

    Rabigh | Khulais | King Abdullah Economic City | Riyadh | Jeddah | Najran |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Peru | Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |