Clinical Data Manager
il y a 1 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
-
Clinical Data Manager
Il y a 5 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** The Clinical Data Scientist 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...
-
Clinical Scientist
Il y a 2 mois
Les Ulis, France Ipsen Bioscience, Inc. Temps plein**Responsibilities**: - Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards) - Partner with the study lead on oversight of clinical trial activities, including safety reviews...
-
Clinical Scientist
Il y a 5 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** Providing leadership and management within Neuroscience Therapeutic Area Clinical Development to provide scientific and clinical development support for products (assets) within assigned therapy area. Support development and execution of medical & clinical strategy for assigned Ipsen assets(s). Conduct scientific...
-
Clinical Monitoring Lead
Il y a 6 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Purpose of the position** - Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Ph2/3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of...
-
Clinical Monitoring Lead
Il y a 6 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinPlease send your CV in English ! **Purpose of the position** - Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Ph2/3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the...
-
Global Clinical Monitoring Lead F/m
il y a 4 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Main responsabilities** Ensure clinical activities coordination & oversight: - Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc ): to verify timely collection of essential study documents, such as regulatory and...
-
Clinical Biomarker Principal Scientist F/m
Il y a 3 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinThe clinical Biomarkers principal scientist will be responsible for defining the biomarker strategy, from biomarker identification, through clinical implementation, and up to companion diagnostics development, for multiple programs covering all three therapeutic areas, where needed. He/She will also be responsible for monitoring biomarkers in clinical...
-
Clinical Trial Associate
Il y a 5 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinPlease send your CV in English ! **Purpose of the position** - Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies - Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting...
-
Clinical Trial Associate
Il y a 5 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Purpose of the position** - Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies - Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking - Responsible for...
-
Scientist Clinical Biomarkers
Il y a 6 mois
Les Ulis, France IPSEN Temps plein**Title**: Scientist Clinical Biomarkers H/F **Company**: Ipsen Innovation (SAS) The clinical Biomarkers scientist will be responsible for successfully driving biomarkers activities, for multiple programs covering all three therapeutic areas (Oncology, Neuroscience, Rare Diseases), where needed. He/She will contribute to define biomarker plans for each...
-
Senior Scientist Clinical Biomarkers
Il y a 3 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Primary responsibilities**: - Contributes to the development of clinical biomarker strategies and establishes biomarker plans for target engagement, pharmacodynamics, mechanism of action, and patient selection that are suitable for informed decision-making - Monitors clinical implementation and validation of biomarkers - Selects the most relevant...
-
Director, Clinical Development Programs
il y a 1 mois
Les Ulis, France Ipsen Biopharm Ltd Temps plein**Position** Job Title**:Director Clinical Development Programs (CPD)** Division / Function: CDO Manager (Job Title): VP, Clinical Development Operations Neurosciences Location: UK (London) or France (Paris) or USA (Cambridge) **Summary / purpose of the position** - The Clinical Program Director holds full accountability for the global aesthetics...
-
Senior Clinical Monitoring Lead
Il y a 2 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinThe Senior Clinical Monitoring lead is fully accountable for all clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Phase I to III clinical studies in accordance with GCP guidelines and regulations. - He/she builds strong relationships with investigators and proactively acts as...
-
Principal Statistical Programmer
il y a 2 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Principal Statistical Programmer** **Summary / purpose of the position** Position will participate in production/QC programming, project coordination, CRO management and oversight of vendor programming across Ipsen rare disease studies. **Main responsibilities / job expectations** **Responsibilities will include, but are not limited to the...
-
Non-clinical Drug Safety Senior Project Manager
Il y a 3 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Missions**: - Optimize nonclinical development plans for products. - Collaborate with project/asset teams to deliver optimized development plans. - Handle non-clinical drug safety aspects in various documents (lB, CIA, IMPD, IND, Briefing documents, Expert reports). - Contribute to non-clinical modules for submissions. - Represent the nonclinical function...
-
Principal Statistical Programmer
Il y a 5 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**#LI-Remote** LI-MC1 **Summary / purpose of the position** Position will participate in exploratory programming, project coordination, CRO management and QC of vendor programming across therapeutic areas of Oncology and Rare Disease, to ensure the efficiency and quality of Biostatistical/Programming deliverables in support of Health Technology...
-
Principal Statistical Programmer
il y a 3 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Principal Statistical Programmer** **Summary / purpose of the position** Position will participate in production/QC programming, project coordination, CRO management and oversight of vendor programming across Ipsen rare disease studies. **Main responsibilities / job expectations** **Responsibilities will include, but are not limited to the...
-
Etmf Specialist
Il y a 5 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein#IpsenTraineeSquad_ **Purpose of the mission** **eTMFs Quality control**: - Perform quality control of Sponsor documents submitted to the eTMF using the established acceptable criteria. - Complete the QC workflow in either approving document or raising a quality issue to the document owner. - Ensure documents which fail TMF quality control and/or TMF...
-
Senior Manager Biostatistics
Il y a 3 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** - The Senior Biostatistician for Health Technology Assessments (HTA) is an Ipsen Global Biometry biostatistician supporting the development of HTA, in collaboration with Ipsen Health Economics and Outcomes Research (HEOR) and Global Value and Access teams. - He/She is responsible for the discussion and implementation of...
-
HR Manager
il y a 3 semaines
Les Ulis, France Colt Data Centre Services Temps pleinWe are seeking an experienced HR Manager to join our high-growth company to support employees based in Europe with queries across their whole employment life cycle and will particularly provide technical expertise on European employment law matters to managers at all levels. The HR Manager will be part of the DCS People Team and will also work...