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Clinical Data Coordinator A client of dEEVOiR Consulting Services Pvt. Ltd.

By: Mitul Shah | Views: 961 | Date: 06-Jan-2011

Job detail for the post of Clinical Data Coordinator in A client of dEEVOiR Consulting Services Pvt. Ltd. Mumbai, 2 to 4 years of experience. Apply for the job Now ! Search Jobs in India by Functional Area, Industry and Location. Search Jobs in India - Delhi, Mumbai, Bangalore, Kolkata. Find career openings in top companies. Post your resume and find your dream job Now !.

Summary

Experience:

2 - 4 Years

Location:

Mumbai

Education:

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

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Clinical Research Associate/Scientist

Functional Area:

Healthcare, Medical, R&D

Posted Date:

06 Jan

Desired Candidate Profile

- Post-graduate degree in Statistics or Mathematics or Bachelor’s degree in Engineering in Computer Science.

- 2 years experience in related field. (Pharma preferred)

- Experience working on Oracle Clinical.

- Coordination and management of data management activities.

 

Kindly mail your updated Profile / CV in a word format along with the following details:



1. Current CTC

2. Expected CTC

3. Notice Period

4. Current Location

5. Relocation to Mumbai (Yes/No)

6. Total years of experience

7. Skills / Expertise

8. Passport details

9. Do you hold any visa?

10. Professional references -Two (Name, Designation, and Company & Contact)

 

Job Description

- Review/design CRF, Reviewing CRF Completion Guidelines/Mock CRFs and coordinating review and approval process.

- Reviewing and approving Data Management Plan components (Study Summary/Data Flow Diagrams, Timelines, Critical Variables list, etc) in coordination with Biometrics and Project manager.

- Reviewing Data Validation Specifications and coordinating input from Biometrics department to ensure that Statistical Analysis Plan (SAP) requirements will be met.

- Handling AE/SAE reconciliation.

- Monitoring external batch data loading and any CRF to electronic data inventory reconciliation

- Coordinating with Biometrics to ensure timelines for data deliverables by requesting and reviewing relevant metric reports.

- Keeping the Clinical Trial team and Biometrics department personnel informed about project status on a regular basis and about issues as they arise.

- Working cooperatively and constructively with the Biometrics to develop effective solutions to operational data management problems.

- Tracking problems to their resolution.

- Evaluating ongoing quality of Biometrics services by; Sampling OC discrepancies and reviewing - Data Clarification Form (DCF) generation, tracking and processing.

- Reviewing OC/ SAS data monitoring tools.

- Participating in OC database closeout planning and tracking.

- Perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation before submitting to biometrics.

- Review clinical trial data in accordance with Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.

- Managing medical coding process.

- Actively contributing to the review of working practices and the development of SOPs

- Support the training of project staff on project-specific, global, standardized data management processes.

- Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), CRF (eCRF) completion guidelines, DMP etc.

- Team player that works and communicates well with an interdisciplinary Clinical Trial Team and other Biometrics personnel.

- Train clinical team and site on CRF filling.

- Spearhead eCRF implementation programme.

Keywords: clinical data, clinical data management, clinical data associate, data management, data entry, CRF, Oracle clinical

Company Profile

Our client will be the domestic small and mid cap growth fund. Our client will diversify the fund and will invest across varied sectors. Fund will focus on early stage investing, where our client can hand hold promoters financially as well as operationally.
Contact Details
Company Name:

A client of dEEVOiR Consulting Services Pvt. Ltd.

Executive Name:

Kiran Ahuja

Address:

dEEVOiR Consulting Services Pvt Ltd
505,'B Wing', KEMP Plaza, Off. Chincholi Bunder
Rd. Extn, Malad (West)
MUMBAI,Maharashtra,India 400064

Email Address:

kirana@deevoir.com

Telephone:

91-22-40032050

Reference ID:

Clinical Data Coordinator

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