Clinical Lead
il y a 4 jours
Clinical Data Management Expert Wanted
We are seeking an experienced Clinical Data Management professional to join our team at Ipsen Pharma.
About the Role
The successful candidate will be responsible for defining, implementing, and monitoring the Data Management strategy for clinical studies in our portfolio. This includes ensuring high-quality data collection, processing, and reporting, as well as overseeing external vendors and managing project timelines.
Key responsibilities include:
- Developing a comprehensive data management strategy for each study, including data capture tools, management of external data, and data flow for submissions
- Ensuring compliance with international standards (ICH, GCP, CDISC) and regulations related to clinical studies
- Overseeing the activities of external vendors and reporting on project status to the Study Team/Submission Team
- Maintaining high-quality databases within Ipsen's data warehouse and ensuring that requirements from the clinical study protocol and statistical analysis are fulfilled
- Monitoring data quality, completeness, and trends between subgroups, and coordinating necessary activities to reach database lock milestones
- Participating in the implementation of data quality systems and procedures, identifying areas for improvement, and contributing to the continuous improvement of Ipsen's Data Management system
Requirements
To succeed in this role, you will need:
- More than 5 years of experience in Clinical Data Management, with proven project management capabilities in a pharmaceutical company or CRO
- Excellent organizational and project management skills, with ability to manage multiple projects simultaneously
- Advanced knowledge of clinical studies' Data Management, including electronic data capture and data management software (e.g., Medidata RAVE)
- High-level expertise in international standards (ICH, GCP, CDISC) and regulations related to clinical studies
- Good budget management understanding and ability to communicate efficiently with external vendors and internal partners
- Familiarity with therapeutic area-specific standards and best practices on data collection and usage
What We Offer
In addition to a competitive salary ($115,000 - $140,000 per annum), we offer a range of benefits, including:
- A dynamic and supportive work environment
- Ongoing training and development opportunities
- A comprehensive compensation package, including health insurance, retirement plan, and paid time off
Join Our Team
Ipsen Pharma is an equal opportunities employer and welcomes applications from candidates of all backgrounds. If you are a motivated and experienced Clinical Data Management professional looking for a new challenge, please apply today.
-
Clinical Data Management Project Lead
il y a 1 semaine
Les Ulis, Île-de-France Ipsen Pharma Temps pleinThe Clinical Data Management Project Lead position at Ipsen Pharma offers a unique opportunity to join a dynamic team and take on a challenging role in the pharmaceutical industry. As a key member of our clinical data management team, you will be responsible for defining, implementing, and monitoring the data management strategy for one or more clinical...
-
Lead Biostatistician for Clinical Data Analysis
il y a 4 jours
Les Ulis, Île-de-France Ipsen Pharma Temps pleinAbout Ipsen PharmaIpsen Pharma is a leading pharmaceutical company that specializes in developing innovative treatments for rare diseases.Job DescriptionWe are seeking a highly skilled Lead Biostatistician for Clinical Data Analysis to join our team. The successful candidate will be responsible for analyzing and interpreting clinical trial data, ensuring the...
-
Senior Clinical Data Manager
il y a 6 jours
Les Ulis, Île-de-France Ipsen Pharma Temps pleinJob OverviewWe are seeking a skilled Clinical Data Manager to join our Ipsen Pharma team. As a key member of our clinical data management team, you will play a critical role in ensuring the high-quality collection, processing, and reporting of clinical data.About the RoleThe successful candidate will have a minimum of 2 years' experience as a Clinical Data...
-
Data Management Specialist Lead
il y a 4 jours
Les Ulis, Île-de-France Ipsen Pharma Temps pleinAbout the RoleWe are seeking a skilled Data Management Specialist Lead to join our team at Ipsen Pharma. The ideal candidate will have a strong background in clinical data management and experience leading cross-functional teams.Job DescriptionThe Data Management Specialist Lead will be responsible for defining, implementing, and monitoring the Data...
-
Data Management Project Lead
il y a 7 jours
Les Ulis, Île-de-France Ipsen Pharma Temps pleinAbout Ipsen PharmaIpsen Pharma is a global pharmaceutical company dedicated to improving patient outcomes through innovative treatments and therapies.Job DescriptionWe are seeking an experienced Data Management Project Lead to join our team in Les Ulis, France. The successful candidate will be responsible for delivering high-quality databases to support...
-
Spécialiste en Biologie Clinique
il y a 6 jours
Les Mureaux, Île-de-France Eurofins GSC Poland Sp. z o. o. Temps pleinLe Groupe Eurofins est l'un des leaders mondiaux sur le marché des services bio-analytiques. La division Clinical Diagnostics d'EUROFINS contribue au bien-être et à la santé de tous en fournissant à ses clients des services d'analyse et de conseil de haute qualité.Pour ce poste, nous privilégions le statut de Travailleur non Salarié...
-
Clinical Monitoring Lead
il y a 4 jours
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 Phase I to III clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards...
-
Clinical Monitoring Lead
Il y a 7 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 Scientist
Il y a 3 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...
-
Senior Clinical Monitoring Lead
Il y a 3 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...
-
Clinical Lead H/F
il y a 1 semaine
Les Ulis, Essonne, France Ipsen Pharma Temps pleinClinical Data Management Study Lead F/M Ipsen Innovation (SAS) The Clinical Data Management (CDM) Study Lead defines, implements and monitors the Data Management strategy for one or more clinical studies in Ipsen portfolio. This includes monitoring the quality, anticipating and mitigating the risks as part of the risk management plan and measuring the...
-
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...
-
Clinical Scientist
Il y a 6 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 Data Management Study Lead F/m
il y a 3 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** The Clinical Data Management (CDM) Study Lead defines, implements and monitors the Data Management strategy for one or more clinical studies in Ipsen portfolio. He/She is responsible for delivering of high-quality databases by external vendors in adherence to Ipsen standards, meeting project timelines and budget. This...
-
Global Clinical Monitoring Lead F/m
Il y a 2 mois
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...
-
Director, Clinical Development Programs
Il y a 2 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...
-
Clinical Data Management Study Lead F/M
il y a 1 semaine
Les Ulis, Essonne, France Ipsen Pharma Temps pleinTitle: Clinical Data Management Study Lead F/M Company: Ipsen Innovation (SAS) Job Description: Summary / purpose of the position The Clinical Data Management (CDM) Study Lead defines, implements and monitors the Data Management strategy for one or more clinical studies in Ipsen portfolio. He/She is responsible for delivering of high-quality databases...
-
Clinical Team Leader
Il y a 6 mois
Issy-les-Moulineaux, France Johnson & Johnson Temps plein**Nous recherchons actuellement un.e Clinical Team Leader - Biosense Webster H/F en CDI** **Le poste est à pourvoir dès que possible et est basé soit à Reims, soit à Nancy.** **Les départements concernés sont 51, 10, 54, 57, **des déplacements Region Nord Est et France entière sont à prévoir.** Vous voulez contribuer à un projet de grande...
-
Principal Statistical Programmer
Il y a 6 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...
-
Senior Manager, Cmc Technical Writing
Il y a 3 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinJob Title**:Senior Manager, CMC Technical writing Division / Function: Global Regulatory Affairs (GRA) Manager (Name, Job Title): Director/ Sr Director, CMC Regulatory Location: Balard/ Dublin/ Paddington **Summary / purpose of the position** The Senior manager, CMC-technical writing will have responsibility for the CMC (Chemistry Manufacturing and...
-
Biometric Systems Manager F/m
il y a 23 heures
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** The Biometric Systems Manager drives successful implementation and use of clinical data management systems (CDMS) and Statistical Computer environment (SCE) in relation to planning, Implementation, Adoption & Maintenance. The Biometric Systems Manager delivers projects working multidisciplinary teams such as data...
-
Agent Polyvalent Manutentionnaire
Il y a 3 mois
Les Mureaux, France Eurofins France Clinical Diagnostics - Biologie Médicale Temps plein**Description de l'entreprise**: - Le Groupe EUROFINS (6,515 milliards d’euros de chiffre d’affaires en 2023 et figurant parmi les valeurs les plus performantes d’Europe depuis 20 ans, avec plus de 900 laboratoires répartis dans 62 pays et 62 000 collaborateurs) est l’un des leaders mondiaux sur le marché des services bio-analytiques. La division...
-
Senior Manager, Global Labelling
Il y a 3 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** **To develop and maintain Core labelling documents and support USPI/other local product information throughout the product life cycle in accordance with Ipsen Processes for assigned product(s)** **To provide labelling guidance to support product teams and senior management in defining labelling strategy** **To provide...
-
Senior Director Cmc Regulatory Strategy
il y a 1 semaine
Les Ulis, France Ipsen Innovation (SAS) Temps pleinJob Title**: Sr Director CMC Regulatory Strategy - Small molecules** Division / Function: Global Regulatory Affairs (GRA) Manager (Name, Job Title): Head of CMC Regulatory Strategy Location: Balard/ Paddington **Summary / purpose of the position** - Leads the team to deliver high quality CMC-Regulatory files, ensuring alignment of regulatory strategy...
-
Senior Director Regulatory Cmc Strategy
il y a 1 semaine
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** - Leads the team to deliver high quality CMC-Regulatory files, ensuring alignment of regulatory strategy with all stakeholders. - Takes accountability/decision making for all Global CMC-Regulatory files in the biologic cluster. - Accountable for early communication and validation from worldwide health authorities for any...
-
Medical Advisor
Il y a 6 mois
Issy-les-Moulineaux, France Johnson & Johnson Temps plein**For our Medtech sector, we are currently recruiting a **Medical Advisor (M/F) - Orthopaedics & Knee Surgery **on a permanent contract. This role is based in our Issy-les-Moulineaux office and includes 30% travels.** **Overall purpose**: DePuy Synthes (DPS) Field Medical Advisor (MedAdv) is DPS’ scientific expert in France and contributes to the...