Data Manager (fmd)
Offer summary
Qualifications:
University degree in natural sciences or a related field., Working knowledge of ICH GCP guidelines., Experience with data management in clinical trials is preferred., Proficiency in English, both written and spoken..Key responsibilities:
- Develop and maintain study databases and (e)CRF modules.
- Coordinate data entry, cleaning, and query management activities.
- Participate in meetings and training sessions related to clinical research.
- Create and implement strategies for clinical research database introduction in compliance with international standards.
Job description
Company Description
Eurofins bioskin is a leading niche CRO with unique understanding and capabilities for both early and late phase development of dermatological and related products. Since its inception in 1992, bioskin has been recognized as a valuable partner for dermatological product development. Starting as a small Contract Research Organization (CRO) specialized in conducting early phase safety and efficacy trials, bioskin has grown into a fullservice CRO offering global dermatologic consulting and regulatory services and all services for management of Phase IIV drug trials and claim supportsafety studies. bioskin is headquartered in Hamburg, Germany.
Job Description
We are looking for an Data Manager in clinical trials to join our team at Eurofins bioskin. The Data Manager is responsible for creating Case Report Forms (eCRFpCRF), developing and maintaining study databases, and coordinating data entry, data cleaning, and query management.
Your main responsibilities:
- Familiarization with current scientific developments within the scope of the task area
- Participation inorganization of meetings and telephone conferences inhouse with clients training sessions, seminars
- Development and implementation of strategies for the introduction of clinical research databases in accordance with the applicable international standards (ICH, GCP, CDISC) and
- Development of (e)CRF standard modules and
- Creation and revision of data management SOPs and the workflows described therein
- Project management within the scope of DM activities
- Preparation of a studyspecific scheduleschedule (timelines) of tasks related to the function in coordination with the relevant departments
- Creation and adherence to the auditspecific Data Management Plan and related documents
- Definition, programming and validation of completeness and plausibility checks (edit checks) and data transfer.
- Data review, data cleaning and query Management
- Third Party data Device data handling
- Coding of diseases, adverse events and drugs according to studyspecific coding systems, e.g. WHO Drug Global or MedDRA.
- Organization and execution of third party and SAE reconciliation.
Qualifications- University degree in natural sciences or other comparable degree
- Working knowledge of ICH GCP guidelines
- Experience in development of data structures according to CDISC standards would be a nice to have
- Dependable, wellstructured and organized, targetoriented personality, team player
- Well versed in English (written and spoken)
Additional Information
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your application including anticipated salary.
Eurofins bioskin is a leading niche CRO with unique understanding and capabilities for both early and late phase development of dermatological and related products. Since its inception in 1992, bioskin has been recognized as a valuable partner for dermatological product development. Starting as a small Contract Research Organization (CRO) specialized in conducting early phase safety and efficacy trials, bioskin has grown into a fullservice CRO offering global dermatologic consulting and regulatory services and all services for management of Phase IIV drug trials and claim supportsafety studies. bioskin is headquartered in Hamburg, Germany.
Job Description
We are looking for an Data Manager in clinical trials to join our team at Eurofins bioskin. The Data Manager is responsible for creating Case Report Forms (eCRFpCRF), developing and maintaining study databases, and coordinating data entry, data cleaning, and query management.
Your main responsibilities:
- Familiarization with current scientific developments within the scope of the task area
- Participation inorganization of meetings and telephone conferences inhouse with clients training sessions, seminars
- Development and implementation of strategies for the introduction of clinical research databases in accordance with the applicable international standards (ICH, GCP, CDISC) and
- Development of (e)CRF standard modules and
- Creation and revision of data management SOPs and the workflows described therein
- Project management within the scope of DM activities
- Preparation of a studyspecific scheduleschedule (timelines) of tasks related to the function in coordination with the relevant departments
- Creation and adherence to the auditspecific Data Management Plan and related documents
- Definition, programming and validation of completeness and plausibility checks (edit checks) and data transfer.
- Data review, data cleaning and query Management
- Third Party data Device data handling
- Coding of diseases, adverse events and drugs according to studyspecific coding systems, e.g. WHO Drug Global or MedDRA.
- Organization and execution of third party and SAE reconciliation.
Qualifications- University degree in natural sciences or other comparable degree
- Working knowledge of ICH GCP guidelines
- Experience in development of data structures according to CDISC standards would be a nice to have
- Dependable, wellstructured and organized, targetoriented personality, team player
- Well versed in English (written and spoken)
Additional Information
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your application including anticipated salary.
We are looking for an Data Manager in clinical trials to join our team at Eurofins bioskin. The Data Manager is responsible for creating Case Report Forms (eCRFpCRF), developing and maintaining study databases, and coordinating data entry, data cleaning, and query management.
Your main responsibilities:
- Familiarization with current scientific developments within the scope of the task area
- Participation inorganization of meetings and telephone conferences inhouse with clients training sessions, seminars
- Development and implementation of strategies for the introduction of clinical research databases in accordance with the applicable international standards (ICH, GCP, CDISC) and
- Development of (e)CRF standard modules and
- Creation and revision of data management SOPs and the workflows described therein
- Project management within the scope of DM activities
- Preparation of a studyspecific scheduleschedule (timelines) of tasks related to the function in coordination with the relevant departments
- Creation and adherence to the auditspecific Data Management Plan and related documents
- Definition, programming and validation of completeness and plausibility checks (edit checks) and data transfer.
- Data review, data cleaning and query Management
- Third Party data Device data handling
- Coding of diseases, adverse events and drugs according to studyspecific coding systems, e.g. WHO Drug Global or MedDRA.
- Organization and execution of third party and SAE reconciliation.
- University degree in natural sciences or other comparable degree
- Working knowledge of ICH GCP guidelines
- Experience in development of data structures according to CDISC standards would be a nice to have
- Dependable, wellstructured and organized, targetoriented personality, team player
- Well versed in English (written and spoken)
Additional Information
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your application including anticipated salary.
Qualifications
Required profile
Experience
Other Skills
- Teamwork
- Reliability
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