Clinical Data Manager
Il y a 3 mois
**Summary / purpose of the position**
The Clinical Data Manager set-up and oversees the outsourced clinical data management activities for one or several assigned studies under the supervision of the Principal Clinical Data Scientist in charge of the development program.
He/she is accountable (quality, budget and timelines) for the Data Management deliverables as per assignment. He/She ensures that the clinical data collected, processed and reported are of high quality, rigorous, objective and informative (i.e. as per statistical analysis requirements).
In addition, he/she manages the creation and validation of clinical study data packages into the Ipsen central data repository as per program’s needs (transversal activities).
He/she participates in the continuous improvements of internal clinical data management processes.
He/she intervenes across all therapeutic areas.
**Main responsibilities / job expectations**
Main responsibilities:
- Review Scope of Work of the CRO for a given study and support purchasing activities
- Validate proposed budget and limit change orders
- Review Study Synopsis/Protocol, TFLs, CSR
- Review and validate data management deliverables from the CRO for a given study (e.g. Data Management Plan/Report, eCRF Specifications, Edit Check Specifications, Data Transfer Specifications, eCRF Completion Guidelines, Clinical study data package )
- Create the study in the Ipsen central data repository and ensure the corresponding clinical study data package are uploaded accordingly.
- Ensure the clinical study database meets Ipsen Data Standards requirements (it includes the review of the annotated CRF in Ipsen SDTM format, the database specifications, the Pinnacle 21 checks, the Reviewer Guide and the Define.xml)
- Ensure data quality is according to Industry standard and perform quality control on the clinical database (e.g. run of SAS Edit Checks, QC of raw data vs. SDTM datasets)
- Participate in meetings with the CRO and/or study team meetings
- Ensure ongoing and timely data review, data reconciliation and data coding until database lock
- Ensure study timelines are met
- Report and escalate issues if any to the Principal Clinical Data Scientist in charge
- Ensure adherence to GCP, regulatory guidelines, and Ipsen SOPs
- Participate in the continuous improvements of the data management processes (e.g. participate in the development of validation tool)
EHS responsibilities:
- Comply with applicable EHS regulations and procedures.
- Participate in the site's EHS performance by reporting risks, malfunctions or improvements
- Participate in mandatory EHS training
**Experience / Qualifications**
- Minimum 2 years' experience as a Clinical Data Manager in the pharmaceutical industry or in a CRO
- Life Science and/or Information Technology graduate
- Languages: English (oral and written)
**Key Technical Competencies Required**
- Knowledge of ICH and GCPs
- Knowledge of EDC and Data Management processes
- SAS Programming skills
- Knowledge of CDISC SDTM
- Quality-focused and attention to detail
- Good organizational and communication skills
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