Gdo Study Designer - Zurich, Schweiz - MSD

MSD
MSD
Geprüftes Unternehmen
Zurich, Schweiz

vor 1 Monat

Lena Schneider

Geschrieben von:

Lena Schneider

beBee Recruiter
Beschreibung

Position Description:


In connection with other General Data Management Service (GDMS) roles, the Study Designer (SD) role is accountable for:

  • Ensuring quality and consistent E2E data management deliverables within a trial and across trials within their assigned TA.
  • Ensuring the appropriate crossfunctional perspectives are incorporated into the trial design and change control processes.


The role is responsible to support Trial design, including new components and updates to existing Library components as per Protocol/Program design requirements and Industry Standards, as well as monitoring and supporting the ongoing change control of data management deliverables for the life of the trial as needed.


Primary activities include, but are not limited to:

  • Support Study Design activities to ensure complete, comprehensive and high quality E2E design.
  • Interact with study level resources (e.g. BARDS, Clinical, GDMS, External Vendors) to gather trial requirements (including new/updated components) and assure appropriate integration of all data sources.
  • Ensures quality and consistency of the E2E data management specifications within and across trials in a Program and/or Therapeutic Area (TA).

This may include, but is not limited to:

  • Authoring data collection specifications for new and updated components.
  • Including creation, submission and management of the Standards Request Package.
  • Excluding COA & IRT Vendor Specs.
  • Review and approval of Trial data collection specifications, including data Integration and data validation specifications.
  • Support change management, as applicable.
  • Author new data collection components or significant changes to data collection components.
  • Review/approve adding additional existing data collection components.
  • Ensures appropriate use of Global, TA and Industry Standards at the Trial level.
  • Identifies and develops areas for improvement in data management processes, standards and tools.
  • May lead continuous improvement special projects, or any other data management tasks deemed appropriate by management.
  • Mentor and train staff as needed.

Position Qualifications:


  • B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline AND 5 years' experience in Clinical Data Management in the Pharmaceutical industry.
OR

  • 10 Years' experience in End to End Clinical Data Management Trial Design, Build and Execution AND HS Diploma.

Required Experience and Skills:


  • Knowledge of the clinical development process, on the therapy area of interest and on how to translate Protocol requirements into data management specifications
  • Expert knowledge of end to end clinical data management and the impact to downstream consumers
  • Excellent analytical and creative problem solving, critical thinking, conflict resolution, communication, organizational, and multitasking skills
  • Innovative mindset
  • Strong understanding of CDISC/Study Data Tabulation Model (SDTM) and corresponding implementation guides, CDISC terminologies and the related regulations for submission deliverables
  • Process oriented with Quality Assurance/Quality Control prior experience
  • Ability to work under pressure in a changing environment
  • Understanding of data management systems and tools and their interactions
  • Demonstrated leadership and collaboration skills to establish good working relationship within internal teams and external stakeholders
  • Ability to be flexible and work independently.
  • Open to new learning opportunities to improve the way we work.
We are a research-driven biopharmaceutical company.

Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world.

We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.


Who we are


We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.

For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.

Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.


What we look for


Imagine getting up in the morning for a job as important as helping to save and improve lives around the world.

Here, you have that opportunity.

You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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