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Clinical Data Associate - Vibgyor Scientific Research Pvt Ltd

By: Pharma Jobs | Views: 3448 | Date: 16-Jun-2011

VIBGYOR is an ISO 9001:2008 certified, therapeutically focused, scientific CRO offering broad spectrum of clinical research services, such as; Regulatory Affairs, Project Management, Clinical Trial Management, Clinical Monitoring, Data Management, Clinical Study Report Writing and Imaging Core Lab Analysis.VIBGYOR was founded in the year 2000. Cardiovascular Diseases have been one of our key areas of specialization and therapeutic strength, as we have successfully completed and are currently conducting mult

Summary
 

Experience:

2 - 4 Years

Location:

Ahmedabad

Compensation:

As per Industry Standards

Education:

UG - Any Graduate - Any Specialization PG - Any PG Course - Any Specialization

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Documentation/Medical Writing

Functional Area:

Healthcare, Medical, R&D

Posted Date:

16 Jun

Desired Candidate Profile

1. Basic understanding of GCP and ICH guidelines.

2. Bachelor degree in related discipline.

3. A minimum of 2 years or equivalent experience in clinical data management.

4. In addition candidate should be computer literate and possess good verbal and written English language skills.

5. Hands on experience on EDC/RDC.
Job Description

1. Performs responsibilities according to CDM Project Plan, SOPs and Sponsor specific requirements.

2. Performs internal CDM QC audits of the clinical database against the CRFs including query results for paper studies under the Supervision of CDM.

3. Maintains organized, complete and up-to-date study documentation for the project team

4. Coordinates receipt, handling, and reconciliation of data received from external sources (e.g central laboratory, ECG, sponsor coding dictionaries, format libraries, transfer database specifications etc) where applicable.

5. Participates in the training of CDAs by assisting in the development of training plans, conducting training sessions, executing training or mentoring new associates.

6. Demonstrates a general understanding of each assigned protocol, critical tasks and milestones.

7. Ensure completeness, correctness and consistency of routine clinical data and data structure.

8. Assisting in the implementation of routine clinical data management process with CRO including data entry, data quality checking, data transfer, reporting, backup, and recovery.

9. Assists in the preparation of CRF/eCRF for data collection through the regulatory approval process.

10. Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner.

11. Identifies, tracks, and resolves routine queries. Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met

 
Keywords: clinical research, ahmedabad, Vibgyor scientific research, clinical data management.

Company Profile
VIBGYOR is an ISO 9001:2008 certified, therapeutically focused, scientific CRO offering broad spectrum of clinical research services, such as; Regulatory Affairs, Project Management, Clinical Trial Management, Clinical Monitoring, Data Management, Clinical Study Report Writing and Imaging Core Lab Analysis.

VIBGYOR was founded in the year 2000. Cardiovascular Diseases have been one of our key areas of specialization and therapeutic strength, as we have successfully completed and are currently conducting multiple clinical trials in medical devices as well as drugs for various international and domestic sponsors. 

Contact Details
Company Name:

Vibgyor Scientific Research Pvt Ltd

Executive Name:

Bhumika Vyas

Address:

Vibgyor Scientific Research Pvt Ltd
45, World Business House,
Near. Parimal Garden, Ellisbridge,
AHMEDABAD,Gujarat,India 380005

Email Address:

info@vibgyorcare.com

Telephone:

91-79-26565076

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Comments
MAULIK.S.PATEL  |  19-Mar-2013 15:28:19 IST
respected sir/ ma'm myself maulik.s.patel wants to join your industry.i have being completed M.pharm in pharmacology. i accept somehow positive response from your side.please send me your e-mail id ,so i can send my full resume.
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