Offre d'emploi : Senior Clinical Data Manager (M/F)

Recruteur
PaHRtners
Région
Gosselies, Charleroi (BE)
Publication
lundi 2 août 2021
Date limite
jeudi 16 septembre 2021
Type de contrat
CDI
Temps de travail
Temps plein

iTeos Therapeutics is a publicly-held (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies. 

Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UCLouvain) in 2011.

In March 2020, the Company completed a $125 million Series B2 financing, and in July 2020, we completed our IPO raising over $230million of gross proceeds. In June 2021, iTeos entered into a transformative $2.145 billion co-development and co-commercialization agreement with GSK for EOS-448, iTeos’s anti-TIGITmonoclonal antibody. As a well-capitalized biotech company iTeos is positioned to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage our fantastic science to improve the lives of cancer patients.

For more information, please visit www.iteostherapeutics.com.

iTeos Therapeutics is now a world-class biotech in cancer immunotherapy. To carry on its growth, expand its pipeline and reinforce its team, iTeos Therapeutics is looking for a Senior Clinical Data Manager.

 

Responsibilities:

Within the Clinical Operations Team, iTeos is looking for an experienced Clinical Data Professional to oversee all aspects of Clinical Information (Clinical Data Science Manager, CDSM). The CDSM is responsible for the design, storage and dissemination of data collected in clinical trials. This includes creation of data standards, working with cross-functional teams and third-party vendors. The CDSM leads the decision making for data collection options, and the development of data collection tools at Project and study level, and thus is highly responsible for the success of clinical trials. 

Key responsibilities:

  • Creation and maintenance of iTeos data standards including standard Case Report Forms (CRFs)
  • Management of third party vendor data outside of the database such as biomarker, PK and PD data and ensuring consistency of data collection across projects and studies
  • Responsible for the selection and management of third-party providers of data services, including defining vendor responsibilities.
  • Serve as DM representative at project and study team meetings
  • Responsible for defining and managing project level timelines for collection of clinical data and associated study timings 
  • Develop and maintain a roadmap of upcoming data deliverables, and coordinate the delivery of clinical data to meet all reporting requirements
  • Contribute to the optimization of processes, and development of project/study specific tools within the Clinical Operations department, including identification and evaluation of data visualization tools and tools to facilitate data review
  • Oversight of CRO deliverables

Provide data management support (directly and/or through CRO oversight) for ongoing EDC trials:

  • Creation of iTeos corporate level and project level standard CRFs
  • Review of electronic case report forms (eCRFs) for completeness, content and database considerations
  • Perform data review for quality issues and general data trends
  • Manage external data, including the format this is received in, and where it is stored within iTeos
  • Understand/follow and create Data Management Plans (DMP)
  • Oversee data management activities internally and externally and generate metric reports to track and report data status
  • Work with the clinical lead for the study to identify data that requires medical review and facilitate completion of such review
  • Work with the Project/Study level statistician on the requirements for data for abstracts, posters, publications and Interim Analyses

Participate in data management activities in support of new clinical trials:

  • Provide input into study protocols from a data management perspective
  • Participate in eCRF and database design; review DTS (or DTA) with 3rd vendors (eg with analytical labs for PK, PD BMKs)
  • Define edit check specifications
  • Develop UAT test plans and participate in user acceptance testing (UAT)
  • Develop trial specific guidelines as specified (DMP, eCCGs)

Profile:

  • 10+ years of relevant work experience in clinical data management in the pharmaceutical/biotechnology industry.
  • Experience in Oncology trials is preferred.
  • Knowledge of Electronic Data Capture (EDC-related tools and processes), preferably Medidata Rave and ECOA experience
  • Proficient Computer Skills including MS office products
  • Knowledge of database design and database concepts
  • Knowledge of global standards related to data management activities (CRF design, database design and standards)
  • Knowledge of related regulations, GCP and Good Clinical Data Management Practices
  • Knowledge of medical terminology with expertise in oncology preferred
  • Knowledge of coding dictionaries (MedDRA, WHO drug)
  • Experience in oversight of CRO activities
  • Excellent written, verbal and organizational skills
  • Must be detail oriented and have strong prioritization skills
  • Ability to handle multiple projects and be a team player

Offer:

  • A stimulating position within a high-potential innovative biotech company.
  • The opportunity to work in a science-driven, dynamic, respectful and professional environment.
  • A challenging scientific and business growth in which you get to bring your knowledge and skills.
  • A permanent contract with an attractive salary package in line with the position responsibilities and your experience.

Interested? 

Send your CV together with an adapted cover letter via https://www.pahrtners.be/fr/offres-demploi/clinical-data-science-lead-mf/ or to the following address: recruitment@pahrtners.be

Your application and related information will remain strictly confidential.

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