Neeyamo Enterprise Solutions | Current Openings in Bangalore

Contents

1. 1 Neeyamo Enterprise Solutions
2. 2 Job Title:
3. 3 Job Location:
4. 4 Experience:
5. 5 Salary: 
6. 6 Job Description:
7. 7 Roles and Responsibilities: 
8. 8 Minimum Required Education And Experience:
9. 9 Shift Timings:
10. 10 Note :
11. 11 Contact Person:

Neeyamo Enterprise Solutions

Looking for: Centralized Medical Data Reviewers Role

Job Title:

• Sr. Clinical Data Coordinator/Assistant Clinical Data Manager 

Job Location:

• Bangalore 

Experience:

• 2.5- 8 years

Salary: 

• Up to 5.5L per annum.

Industry:

• Pharma, Biotechnology, Clinical Research 

Functional Area:

• Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology 

Role Category:

• Medical Professional

Role:

• Clinical Researcher

Job Description:

• Qualifications :Should have done their MBBS /BAMS/BDS 
• Experience: Minimum 2.5 to 8 years experience in clinical practice or clinical research related field, including 1 year of biopharmaceutical clinical research experience (obtained through working on investigator-sponsored, industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company)
• Comprehensive clinical monitoring experience (CRA experience) will be an added advantage
• Working experience in multi therapeutic area for the clinical trial supported in the process
• Knowledge of ICH Guidelines, Good Clinical Practices (GCP) and / or other international regulations or guidelines where applicable
• Good analytical and problem solving skills.
• Good communicational and interpersonal skills.

Roles and Responsibilities: 

• Ability to review structured clinical patient data output without direct access to medical charts to determine adherence to protocol and overall completeness and readiness of the supplied patient information for next level of review and reporting including but not limited to the following:
• Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy
• Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages
• Review all reported Adverse Events (AEs) to ensure all supporting information is expected and/or implausible data is verified. Review all reported Concomitant Medications to ensure no medication is disallowed per protocol, supports an existing reported medical condition or is prescribed for a reported AE
• Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial
• Ensures proper end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending participation in the clinical trial
• Review all laboratory results to ensure completeness of information supplied, adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient
• Review all patient reported medical history information to verify completeness of reported information, adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
• Review any other information as necessary to determine overall readiness of the patient information for next level review
• Review all supplied Line Listings to determine data accuracy across patients within a specified group of data points
• Review status information and data flow reports and take appropriate actions. Interaction with other Medical review staff to verify information and/or triage new data issues or prior identified action items

Minimum Required Education And Experience:

• MBBS /BAMS/BDS (Minimum 2.5 to 8 years experience in clinical practice or clinical research related field, including 1 year of biopharmaceutical clinical research experience (obtained through working on investigator-sponsored, industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company)

Shift Timings:

• Working in Shifts - 1st Shift starts Morning 6.00 a.m. to 2.00 p.m. and 2nd shift starts 2:30 p.m. to 10:30 p.m.
• Doctors have the flexibility to opt either of shifts, in order to keep a touch with their Private Practice.

Note :

• May vary depending upon the current salary of the prospects.Interested candidates, please drop an email at the following mail id: khushboo.kundra@neeyamo.com

Contact Person:

Khushboo Kundra - Delivery Partner - Staffing

Neeyamo Enterprise Solutions 

Contact No: +91 0120.4186.700 (ext.) 811 

Email Id: khushboo.kundra@neeyamo.com