Career for Clinical Data Manager at Indegene

Indegene is a recognized global leader in providing noticeable healthcare solutions and services and partner to some of the largest and most respected healthcare organizations. Being associated with Indegene, an equal opportunity employer, is about making tangible contributions with a focus to deliver outcomes that are measurable, impactful, and sustainable. We are a team of more than 1,200 employees across 14 global locations.

Post : Clinical Data Manager

Job Summary 
The Senior Clinical Data Manager is responsible for developing the overall strategy of clinical data acquisition and processing data from drug, biologic product or medical device clinical research trials at all stages of clinical development. He or she should provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies in eCRF data in order to ensure consistently high-standard database(s) with respect to cost, quality and timelines.

· 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: 4-5 Years
Location:
Bangalore
Education: B.Pharm,B.Sc,M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 8th August, 2017

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