
Manager, Site Start Up
Zurich, Canton of Zurich- Job Type: Full Time
- Job Level: Senior
- Travel: Minimal
At Takeda, we exist to create better health for people and a brighter future for the world. While we continually evolve science and technology, our ambition remains steadfast — we move science forward so we can transform more lives. The Global Development Organization (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline.
Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development. We’re building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety. GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes.
At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials. It is our passion for people that transforms our work into meaningful action. Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness.
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Job Description
The Clinical Study Startup, Manager oversees and manages the initiation phase of clinical studies. You will ensure that all startup activities are completed efficiently and in compliance with regulatory requirements, contributing to the successful execution of clinical trials.
Objective / Purpose:
The site start up manager defines, develops and delivers the global site start up plan.
Oversee the analysis of clinical trial data and its application to conduct accurate study start up forecasts.
Drive rapid, accurate, and data-driven study start up forecasts, benchmarking assumptions, scenarios and accurate planning.
Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Site Start Up Services.
Accountabilities:
Establish, develop and deliver the Global Site Start Up Plan.
Partner with Clinical Operations teams, and TAU partners to improve overall site start up metrics and implement processes.
Provide guidance, oversight, and training to the Site Start Up team, delivering activities to support Clinical Programs, including data and methodologies for protocol study start up, country and site selection, study start up planning, and modeling.
Ensure standards are applied to the study start up process across project portfolios and support continuous improvement activities while developing TA-aligned strategies.
Guide the collection and analysis of all data to influence site start up timelines.
Leverage leading industry tools and data sources to provide data on start up timelines and performance (data quality, start up cycle time) to assist project teams with site initiation timeline forecasting.
Agree to deliverables on a site-level basis with the SSU team and monitor adherence to these. Promptly recognize and improve potential delays and escalate non-performance.
Lead the site start up team, using the appropriate team members to help implement the Site Start Up Plan.
Drive delivery of all Takeda and CRO supported sites that are "Ready To Enroll"
Resolve escalated issues identified by the site start up team in partnership with the Study Manager
Education & Competencies (Technical and Behavioral):
BS degree or international equivalent in a life science.
4 or more years of experience in Clinical Operations, Project Management, site start up, and trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor.
At least 2 years of direct responsibility in site activation and managing the site start up processes of clinical research studies at a sponsor or CRO.
Proficiency with software models and database structures.
Global SSU experience preferred
Ability to explain data, facilitate decision making processes to be data driven.
Expertise in principles driving country/site start up and study start up strategies.
Please submit your CV, motivation letter, copies of your diplomas, and any reference letters.
Locations
Zurich, SwitzerlandWorker Type
EmployeeWorker Sub-Type
RegularTime Type
80-100%The heart of our work
Shining a light on new perspectives
Our pipeline
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.
Working at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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