Novartis looking for Clinical Data Manager | Pharmacy, Life Science apply

Novartis looking for Clinical Data Manager | Pharmacy, Life Science apply

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

  • As Clinical Data Manager (CDM) provide data management input on Clinical Trial teams. May have the role of TDM on small low complexity trials.
  • 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 performing user acceptance testing (UAT) as applicable.
  • Under supervision ensures consistency of assigned trials with program level standards. With support from the Trial Data Manager gives input into Study Specification worksheets should assigned trials need to be outsourced.
  • Understands third party data requirement and begin to gather an understanding of new technologies that may be used in the course of clinical trials.
  • 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.
  • Verifies and tracks eCRF completion including Query resolution and provides data status updates as needed. Manage local lab set up for the Clinical Database as applicable.
  • 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. Has a working knowledge of FDA and ICH guidelines.

Candidate Profile

Minimum Education : University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree.

Desirable : 3 years’ experience in Drug Development with at least 2 years in Clinical Data Management.

Additional Information

Qualification :  degree in life science, computer science, pharmacy

Location : Hyderabad, AP

Industry Type : Pharma / Healthcare  / Clinical research

Functional Area : Research and Development

Last Date : 30th December, 2021

 

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

  • As Clinical Data Manager (CDM) provide data management input on Clinical Trial teams. May have the role of TDM on small low complexity trials.
  • 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 performing user acceptance testing (UAT) as applicable.
  • Under supervision ensures consistency of assigned trials with program level standards. With support from the Trial Data Manager gives input into Study Specification worksheets should assigned trials need to be outsourced.
  • Understands third party data requirement and begin to gather an understanding of new technologies that may be used in the course of clinical trials.
  • 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.
  • Verifies and tracks eCRF completion including Query resolution and provides data status updates as needed. Manage local lab set up for the Clinical Database as applicable.
  • 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. Has a working knowledge of FDA and ICH guidelines.

Candidate Profile

Minimum Education : University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree.

Desirable : 3 years’ experience in Drug Development with at least 2 years in Clinical Data Management.

Additional Information

Qualification :  degree in life science, computer science, pharmacy

Location : Hyderabad, AP

Industry Type : Pharma / Healthcare  / Clinical research

Functional Area : Research and Development

Last Date : 30th December, 2021

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