Start of mission
October 21, 2019
Job city
Marseille (13008)
Type of contract
Permanent

Description

Overall Objectives and Purpose of the role
In the Clinical Development Department, reporting to the Manager of Biostatistics and Data Management, you will be a core team member within a matrix organization. You will be actively involved in the data management activities for the clinical trials and studies sponsored by Innate Pharma.
 
Within the expanding Biostatistics and Data Management team, you will bring expertise on data management activities, requirements, constraints, and good practices. You will be the main contact for data management subcontractors; you will be in charge of defining and implementing the processes needed to ensure that the clinical data are consistent and reliable; you will coordinate all the stakeholders involved in the data flow from different sources.
 
Within the Clinical Development Department, you will work closely with Clinical Research Directors, Clinical Trial Managers, Safety Manager, in addition to Biostatisticians and other Data Manager(s). You will also have tight interactions with other functions including program management, bioinformatics, clinical pharmacology, and translational research.
 
 
 

Profile

Main responsibilities and key tasks
Oversight of data management CRO













 
Key Tasks:
  • Contributing to the evaluation and selection of the CROs (Contract Research Organizations) for data management questions
  • Overseeing the data management subcontractors concerning the eCRF/EDC design, setup, testing
  • Supervising, reviewing, and validating the data management documents (e.g. data management plan and data validation plan, ...)
  • Planning and implementing data quality review, including programming of checks, conducting review meetings, following up on resolution of findings, ...
  • Ensuring that CROs comply with procedures and regulatory requirements
Management of internal/external data flow









 
Key Tasks:
  • Defining and implementing the data flow process from different vendors and internal research labs toward the clinical database
  • Reviewing and validating the data transfer specifications (DTS)
  • Checking the compliance of external data with respect to the DTS; Managing the resolution of data inconsistencies and reconciliation with clinical database
  • Defining and implementing the process of access and protection of the clinical data, in compliance with good clinical practices and regulatory requirements (GDPR)
Development of internal operating procedures 






 
Key Tasks:
  • Developing standard operating procedures for the internal data management activities
  • Contributing to the development of standard as well as study specific eCRF forms
  • Developing and validating robust internal tools for capturing internal research data
 
 
Experience and Qualifications
Essential:
  • Bachelors or master's degree in Data Management, Life Sciences, Informatics, Biostatistics or similar
  • At least 5-year experience in Data Management in a CRO or pharmaceutical R&D including oncology trials
  • Experience in CROs oversight
 
Desirable:
  • Experience of interactions with FDA for BLA (Biologics Licence Application)
  • Experience in rare disease
  • Experience in a biotech company and/or small biometrics unit



 
 
Competencies, Skills and Behaviours
Technical Competencies Additional Skills/ Behaviours
Essential:
  • Experience with eCRF/EDC systems
  • Good knowledge of SAS
  • Knowledge of ICH, FDA, and GCP regulations and guidelines
  • Operational knowledge of CDISC/SDTM standard




 
Essential:
  • Good communication skills
  • Excellent organization and team spirit
  • Interested in multidisciplinary work and focused on team goals
  • Ability to work in an ever-evolving context, with partial information; ability to adapt and be flexible to ongoing and moving tasks
  • Knowledge of written and oral English
 
Desirable:
  • Knowledge of GDPR
  • Knowledge of R
  •  
Desirable:
  • Knowledge of written and oral French