Clinical Data Manager - 100%
TEOXANE SA — GENEVE
11.09.2019 | Employee | 100%

Teoxane Laboratories were founded in 2003 in Geneva, Switzerland. Teoxane is among the top 3 Hyaluronic acid dermal filler manufacturers worldwide.  Our dedication to innovation and excellence allows us to deliver a strong growth platform in the rapidly changing Aesthetics environment.  We have a significant global presence in over 90 countries worldwide.

Clinical Data Manager

Job Summary:

 

Part of the clinical operation department, this role will be responsible of successful implementation of clinical data management activities related to the clinical studies sponsored by Teoxane. The Clinical Data Manager will provide clinical data management support to the clinical operation team and clinical study project in accordance with time, budget and quality standards within a young and dynamic environment.

 

Responsibilities:

  • Develop and maintain electronic (EDC) or paper case record form of clinical studies sponsored by Teoxane in compliance with international regulatory authorities, preferably in CDISC format.
  • Lead EDC development outsourced to CRO and manage related activities including setting up of data transfer agreements and appropriate clinical database reconciliation with Teoxane internal database (ie safety database)
  • Setup and lead clinical trial data and EDC specifications, EDC design, edit checks programming
  • Develop and update throughout clinical study lifecycle data management documentation (Data Management Plan, Data Validation Plan…) in accordance with local regulations, GCP, and internal SOPs. Ensure appropriate archiving/filing in TMF of DM related documentation. 
  • Manage user access to the clinical database. Ensure appropriate training is received.
  • Closely collaborate with clinical project manager to ensure quality of clinical data throughout the clinical study lifecycle to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review or final database lock.
  • Participate in the development and maintenance of Data management SOPs.

 

Qualifications and Job Specifications:

  • Minimum B.Sc. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
  • Minimum of 4 years of experience in clinical data management. Knowledge of CDISC standards is required
  • Experience in biostatistics and/or SAS programming is a plus
  • Strong critical thinking and problem solving skills
  • Able to rapidly adapt to changing environment and circumstances
  • Fluent in English and French

 

11.09.2019
Employee, 100%

Required minimum profile

  • Minimum B.Sc. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
  • Minimum of 4 years of experience in clinical data management. Knowledge of CDISC standards is required
  • Experience in biostatistics and/or SAS programming is a plus
  • Strong critical thinking and problem solving skills
  • Fluent in English and French

Contact

TEOXANE SA
Rue de Lyon, 105
1203 GENEVE
TEOXANE SA
Rue de Lyon, 105
GENEVE

Industry

Biotechnology / Chemistry / Pharmaceutical

Year of foundation

2003
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