Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Clinical Data Manager
Job Description
1. As Clinical Data Manager (CDM) provide data management input on Clinical Trial teams. May have the role of TDM on small low complexity trials
2. Performs DM activities for start up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP) Data Review Plan (DRP) and performimg user acceptance testing (UAT) as applicable
3. Manage local lab set up for the Clinical Database as applicable
4. Under supervision ensures consistency of assigned trials with program level standards
5. Understands third party data requirements and begins to gather an understanding of new technologies that may be used in the course of clinical trials
6. Performs ongoing review of all data generated from the clinical study including Third party and local lab data as well as SAE reconciliation where applicable
7. Ensures activities that are performed are done with quality and understanding of the process
8. Verifies and tracks eCRF completion including Query resolution and provides data status updates as needed
9. With support from the Trial Data Manager develops proposals to resolve issues that may occur during the running of assigned trials
10. With support from the Trial Data Manager gives input into Study Specification worksheets should assigned trials need to be outsourced
11. Has a working knowledge of FDA and ICH guidelines
12. Has proven ability to use the tools available to generate listings for data review and where necessary provides these to the study teams. Generates the study status reports for use at Clinical trial team meetings.
1. As Clinical Data Manager (CDM) provide data management input on Clinical Trial teams. May have the role of TDM on small low complexity trials
2. Performs DM activities for start up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP) Data Review Plan (DRP) and performimg user acceptance testing (UAT) as applicable
3. Manage local lab set up for the Clinical Database as applicable
4. Under supervision ensures consistency of assigned trials with program level standards
5. Understands third party data requirements and begins to gather an understanding of new technologies that may be used in the course of clinical trials
6. Performs ongoing review of all data generated from the clinical study including Third party and local lab data as well as SAE reconciliation where applicable
7. Ensures activities that are performed are done with quality and understanding of the process
8. Verifies and tracks eCRF completion including Query resolution and provides data status updates as needed
9. With support from the Trial Data Manager develops proposals to resolve issues that may occur during the running of assigned trials
10. With support from the Trial Data Manager gives input into Study Specification worksheets should assigned trials need to be outsourced
11. Has a working knowledge of FDA and ICH guidelines
12. Has proven ability to use the tools available to generate listings for data review and where necessary provides these to the study teams. Generates the study status reports for use at Clinical trial team meetings.
Candidtae Profile
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. Fluent English (oral and written).
1. Strong technical skills,
2. Fluent English verbal and written
3. Ideally 3 years experience in Drug Development with at least 2 years in Clinical Data Management.
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. Fluent English (oral and written).
1. Strong technical skills,
2. Fluent English verbal and written
3. Ideally 3 years experience in Drug Development with at least 2 years in Clinical Data Management.
Additional Information
Experience : 2 years
Qualification : B.Sc, B.Pharm
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th January, 2018
Experience : 2 years
Qualification : B.Sc, B.Pharm
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th January, 2018
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