Process & Clinical Data Manager - Pharma

Job title : Process & Clinical Data Manager - Pharma
Location : France
Job type : Permanent
Salary : Negotiable
Contact name : Yanick Millet
Contact number : +44 (0) 207 255 6632
Contact email : yanick.millet@seclifesciences.com
Position : Senior Clinical Data Manager, Clinical and Process Development
Department : Biometrics
Company : Biotech company, Oncology
Location : France, remote + office
Working condition : Remote based position in France with business travel onsite

My partner is an exciting Biotech at clinical stage, with a auspicious pipeline in Oncology.

To support the Biometrics department, we are recruiting a Senior Clinical Data Manager with a strong background in CRO oversight from the sponsor's side, CDISC - SDTM experience and able to enhance the existing process.

The Senior CDM will be :
- the main contact for data management subcontractors;
- in charge of defining and implementing the processes needed to ensure that the clinical data are consistent and reliable;
- coordinate all the stakeholders involved in the data flow from different sources.

The Senior CDM will work closely with Clinical Research Directors, Clinical Trial Managers, Safety Manager, in addition to Biostatisticians and other Data Manager as well as a tight interactions with other functions including program management, bioinformatics, clinical pharmacology, and translational research.

Responsibilities :
- 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
- 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
- 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


Requirements:
- 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
- knowledge of CDISC/SDTM standard

Nice to Have:
- Experience of interactions with FDA for BLA (Biologics Licence Application)
- Experience in rare disease
- Experience in a biotech company and/or small biometrics unit
- Experience with eCRF/EDC systems
- understanding of SAS, mainly for reporting
- Knowledge of ICH, FDA, and GCP regulations and guidelines

Competitive package + benefits

Please contact me at yanick.millet@seclifesciences.com.