Indegene's scientific and competitive intelligence services lend actionable insights to clients to support their strategic decision making. We provide scientific, clinical, and competitive insights to help align the business development, licensing, clinical development, and marketing activities of our clients to current and future market needs.
Post: Clinical Data Manager
Job Description:
- Review clinical trial protocol and provide professional input on clinical trial team(s)
- Develop database build specifications
- Develop data validation specifications
- Input and review clinical trial database design including user acceptance testing (UAT)
- Be responsible for the validation and analysis plan (VAP) meeting for the clinical trial, which includes chairing the meeting and writing the study-specific validation checks and necessary reports to ensure high-quality and consistent data
- Create CRF, completion guidelines (CCG), SAE reconciliation guidelines and so on
- Validate and clean data, conduct medical coding if assigned and conduct SAE and third-party data reconciliations
- Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock
- Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site to ensure high-quality and timely database locks
- Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design
- Support and provide leadership to data management staff for allocated trials
- Perform training on data management software and practices or trial-specific topics as required
- Prepare training materials for data management activities and processes as required
- Be willing to travel as needed
Candidate Profile:
* Education: Graduate or post graduate in M. Pharm/B. Pharm/B.Sc. (biotechnology)/M.Sc. (biotechnology)/PG Diploma in Clinical Research
* Technical skills: Knowledge of Medidata Rave and Oracle Inform
* Experience: 4+ years of relevant data management experience in lifescience industry
* Working knowledge of good clinical practices, clinical research and clinical trial process
* Working knowledge of clinical data base management applications
* Strong problem-solving skills and willingness to roll up the sleeves to get the job done
* A solid grasp of project management basics
* Ability to work both independently and in a team environment
* Excellent verbal, written and communication skills
* Good organisational and project management skills
Additional Information:
Experience: 4+ Year
Location: Bangalore
Education: B.Pharm,B.Sc,M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CDM
End Date: 10th April, 2017
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