Notifications

Are you open to new opportunities?

Upload your resume to increase your chances of getting noticed.

AB Science
2.3
Clinical Data Analyst M/F
Paris
Archive documents in the clinical data management TMF. At least 5 years of experience in Clinical trials, preferably in Clinical Data Management.…
30d+
data analyst jobs in Paris Paris jobs AB Science jobs in Paris
AB Science salaries
Employee reviews at AB Science AB Science interview experience Working at AB Science
dsm-firmenich
3.7
Senior Data Scientist / Industrial Data Analyst
Paris
Min. 5 years of experience in a similar role (industry or consultancy). The department ensures sustainable high performance, efficiency, and operational……
30d+
data scientist jobs in Paris Paris jobs dsm-firmenich jobs in Paris
dsm-firmenich salaries
Employee reviews at dsm-firmenich dsm-firmenich interview experience Working at dsm-firmenich
Voodoo
4.3
Lead Data Scientist - BI Prediction
Paris
Engage with colleagues across the company to leverage new ideas and perspectives and demonstrate excellent communication to efficiently cooperate with product……
30d+
data scientist jobs in Paris Paris jobs Voodoo jobs in Paris
Voodoo salaries
Employee reviews at Voodoo Voodoo interview experience Working at Voodoo
Catalina
3.4
Data Analyst Retail F/H
Boulogne-Billancourt
Catalina est un leader reconnu dans la connaissance shopper et les médias numériques et en magasin ciblés avec précision qui personnalisent le parcours des……
30d+
data analyst (h/f) jobs in Boulogne-Billancourt Boulogne-Billancourt jobs Catalina jobs in Boulogne-Billancourt
Catalina salaries
Employee reviews at Catalina Catalina interview experience Working at Catalina

AB Science

2.3

Clinical Data Analyst M/F

Paris

Is your resume a good match?

Use AI to find out how well the skills on your resume fit this job description.

Responsabilities

Ensure the clinical consistency of data used for statistical analyses and clinical study reports
Clinical data to be check includes (but not limited to): laboratory results, adverse events, medical history, vital signs, efficacy measurements and treatments.
Follow-up the resolution of detected issues/inconsistencies via queries process
Participate to the development and maintenance of core study documents pertaining to the section, e.g. the CRF, CRF Completion Guidelines, Data Validation Specifications, Data Management Plan, Data Review Plan etc.
Ensure Clinical Data Management input to other relevant strategic study documents (i.e. Data Management Operation Plan) and vendor contracts (i.e. central lab data transfer agreement)
Detect important medical events.
Perform reconciliation of SAE and AE of Special Interest between the Pharmacovigilance database and the Clinical Study Database.
Detect the forbidden concomitant treatments as per study protocol.
Develop and track timelines to ensure data management milestones are met in coordination with the Clinical and Pharmacovigilance Team.
Archive documents in the clinical data management TMF
Participate to the training and process management within the Clinical Data Review team.
Support the Quality Management System (QMS) by participating in the life cycle of procedure and other applicable documents, declaring non-compliances encountered in the daily operations and following the associated corrective and preventive plans, alerting if necessary and suggesting any possible optimization of the processes.
Function as section representative in audits and regulatory inspections.
Ensure the completion of MedDRA and WHODD Coding of medical terms and concomitant medications in a timely manner, and, by following the company guidelines.
Increase functional effectiveness by supporting departmental efforts to simplify and standardize procedures, sharing best practices and participating in or leading continuous improvement efforts.
Facilitate and/or participate in management and functional area meetings, contributing expertise when necessary through formal or informal presentations.
Support the database programming aspect of the data review plan, including programming of data review reports and regulatory documents.

Requirements

Male or female with University degree (MSc or PhD) in Pharmacy, Pharmacology, Life Sciences or related discipline.
At least 5 years of experience in Clinical trials, preferably in Clinical Data Management.
Knowledge of clinical development process.
Understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training.
Sound familiarity with Office automation tool (i.e. Excel, Word, Power point)
Knowledge of database programming tool is a plus (i.e. SQL, MS Access, SAS, etc.)
MedDRA coding certification is a plus
WHODD coding certification is a plus

Additionnal informations

Permanent position, available immediately
Based in Paris
Salary & package to define according skills and experience

See company reviews

Working here doesn’t have to be a secret

2.3

Recommend to a friend
Approve of CEO
CEO: Alain Moussy
18 Ratings

AB Science

2.3

Clinical Data Analyst M/F

Paris

AB Science

2.3

Clinical Data Analyst M/F

Paris

Is your resume a good match?

Use AI to find out how well the skills on your resume fit this job description.

Responsabilities

Ensure the clinical consistency of data used for statistical analyses and clinical study reports
Clinical data to be check includes (but not limited to): laboratory results, adverse events, medical history, vital signs, efficacy measurements and treatments.
Follow-up the resolution of detected issues/inconsistencies via queries process
Participate to the development and maintenance of core study documents pertaining to the section, e.g. the CRF, CRF Completion Guidelines, Data Validation Specifications, Data Management Plan, Data Review Plan etc.
Ensure Clinical Data Management input to other relevant strategic study documents (i.e. Data Management Operation Plan) and vendor contracts (i.e. central lab data transfer agreement)
Detect important medical events.
Perform reconciliation of SAE and AE of Special Interest between the Pharmacovigilance database and the Clinical Study Database.
Detect the forbidden concomitant treatments as per study protocol.
Develop and track timelines to ensure data management milestones are met in coordination with the Clinical and Pharmacovigilance Team.
Archive documents in the clinical data management TMF
Participate to the training and process management within the Clinical Data Review team.
Support the Quality Management System (QMS) by participating in the life cycle of procedure and other applicable documents, declaring non-compliances encountered in the daily operations and following the associated corrective and preventive plans, alerting if necessary and suggesting any possible optimization of the processes.
Function as section representative in audits and regulatory inspections.
Ensure the completion of MedDRA and WHODD Coding of medical terms and concomitant medications in a timely manner, and, by following the company guidelines.
Increase functional effectiveness by supporting departmental efforts to simplify and standardize procedures, sharing best practices and participating in or leading continuous improvement efforts.
Facilitate and/or participate in management and functional area meetings, contributing expertise when necessary through formal or informal presentations.
Support the database programming aspect of the data review plan, including programming of data review reports and regulatory documents.

Requirements

Male or female with University degree (MSc or PhD) in Pharmacy, Pharmacology, Life Sciences or related discipline.
At least 5 years of experience in Clinical trials, preferably in Clinical Data Management.
Knowledge of clinical development process.
Understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training.
Sound familiarity with Office automation tool (i.e. Excel, Word, Power point)
Knowledge of database programming tool is a plus (i.e. SQL, MS Access, SAS, etc.)
MedDRA coding certification is a plus
WHODD coding certification is a plus

Additionnal informations

Permanent position, available immediately
Based in Paris
Salary & package to define according skills and experience

See company reviews

Working here doesn’t have to be a secret

2.3

Recommend to a friend
Approve of CEO
CEO: Alain Moussy
18 Ratings

Are you open to new opportunities?

4 Operations Research Analyst (Data Scientist) jobs in France

Working here doesn’t have to be a secret

Working here doesn’t have to be a secret