Senior Clinical Data Programmer a Eysin

pubblicato
contatti
Emrick Ardisson, Ginevra Professionals Health Care & Life Sciences
tipologia
Determinato
candidati ora >

specifiche della posizione

pubblicato
luogo di lavoro
Eysin
settore
Settore sanitario
tipologia
Determinato
riferimento
15779
contatti
Emrick Ardisson, Ginevra Professionals Health Care & Life Sciences
telefono
058 201 54 00

descrizione

Are you looking for a new challenge inside a multinational Pharmaceutical Company?

 

We are looking for a Senior Clinical Data Programmer (temporary contract - from July 2021 to December 2022) to assure quality supervision of outsourced activities related to statistical programming deliverables from clinical studies.

Location: Nyon, Switzerland

Contract: 1 year and a half (ending December 2022) with possibility of extension

Start Date: July 2021 

Job Description :

The Senior Clinical Data Programmer will be in charge of performing SAS programming to improve data management activities in the context of clinical studies.

The Senior Clinical Data Programmer may also act as Clinical Data Manager as needed and works closely with the Clinical Study Team to supervise the CROs operational execution of the data management activities by monitoring the quality and timeliness of data management deliverables and ensuring that the data collection tools, data cleaning process and resulting data (including documentation of the process) are delivered according to the highest level of industry standards.

 

Responsabilities:

  • You will be responsible for CDISC compliant submissions of clinical data packages to different regulatory authorities

  • You will be responsible for ad hoc programming of Questions and Answers during Regulatory Review processes to ensure Agency requests are addressed within the requested period of time

  • Contribute to review data deliverables from the CRO to ensure the compliance of the study database with Clinical Data Interchange Standards Consortium (CDISC) and SDTM submission package requirements

  • Develop/improve internal processes and standards for data acquisition, data management and SDTM mapping

  • Oversee and monitor the CROs data management activities in accordance with the study level plan, track the progress of the study and evaluate the quality of the database from study set-up to database lock

 

Skills and Competencies:

  • Bachelor or Master Degree in Life Science

  • 5 years of SAS programming experience

  • 2+ years of Data Management / CRO oversight experience

  • Understanding and experience applying SDTM standards

  • Excellent understanding of CDISC requirements

  • Judgment skills to work accurately and efficiently toward quality result

  • Fluent in both written and oral English

  • Good knowledge of GxP environment, ICH and other relevant guidance documents (from FDA, EMA,…)