Vifor Pharma
Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist.
Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen.
Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.
Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Stellentyp: Vollzeit

Clinical Data Associate, Clinical Data Management - Zurich

Location: Switzerland - Glattbrugg/Zurich
Function: Research and Development
Company: Vifor Pharma
Darya Koblik
International Talent Acquisition Specialist
+41 58 851 89 22
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About you
We are currently looking for a Clinical Data Associate (CDA) to join our Clinical Data Management team in Glattbrugg. In this role you will report to Senior Director, Data Management and support data management team lead for Data Management activities. Your tasks will be the following:
  • Perform all data management tasks as appropriate including, but not to be limited to data review and query management to ensure that quality standards are achieved.
  • Perform reconciliation of the clinical database against safety data, laboratory data and other third-party data as appropriate.
  • Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete or implausible data.
  • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database as required.
  • May run ancillary programs (metrics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
  • Interact with other project team members to support the set-up, maintenance, and closure (e.g. Database Lock) of the Data Management aspects of the project and attend meetings as required.
  • May participate in eCRF Screen Review meetings.
  • May create, review, and/or execute Form and Edit Check Specification User Acceptance Testing by creating/reviewing dummy data to evaluate EDC database functionality.
  • Assist in creation of Study Test Plan and Study Test Report documentation.
  • Modify standard templates to create study specific Data Management Plans, or eCRF completion guidelines.
  • Filing of Data Management documentation and data management related administrative tasks as requested, including maintenance of TMF as required.
  • Demonstrate awareness of project schedules and the importance of hitting deadlines.

The ideal candidate will bring the following skills and experience:

  • Bachelor’s degree in Life Sciences, Computer Sciences, Mathematics, or health-related field preferred
  • Minimum 3 years of relevant pharmaceutical, biotech or CRO experience
  • Experience in Clinical Data Management
  • Knowledge of drug development process preferred, knowledge of science or a scientific background considered
  • Very good time management skills and ability to adhere to project productivity metrics and timelines
  • Excellent communication skills in English (oral and written)
You are a team player, you demonstrate high levels of flexibility and work effectively in a cross-functional, cross-regional environment. You have good organizational ability and interpersonal skills. You have a constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events. You work in line with the Vifor Pharma values.
 
About us

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.

Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.

The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.

Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.

For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are

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