A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Clinical Data Manager
Job Description:
Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines.
Key Areas
1.Provide professional DM input on Clinical Trial Team(s)
2.Input to and review of clinical trial database design including User Acceptance Test-ing (UAT).
3.Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study specific validation checks and necessary reports to ensure high quality and consistent data.
4.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.
5.Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design.
6.Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), elec-tronic or paper.
7.Support and provide leadership for data management staff for allocated trials.
8.Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.
9.Perform training on data management software and practices or trial specific topics as required.
10.Prepare training materials for data management activities and processes as re-quired.
11. Serve as Project Data Manager for large projects or multiple smaller projects providing professional Data Management input on ICT(s).
12.Travel is required as needed.
Candidate Profile:
1. 2 or more years experience in drug development with at least 1-5 years experience in Data Management.OC-RDC and PL/SQL experience preferred.
2.University Science Degree in life sciences, pharmacy, nursing or equivalent relevant experience.
3.Excellent written and oral English skills
4.Understanding of clinical trial methodology, GCP and medical terminology
5.Good computer skills
6.Good organizational and project management skills.
7.Good communication and interpersonal skills
8.Intermediate presentation and problem solving skills
9.Ability to work well in a team
10.May coordinate and provide direction on task to other data management team members
Additional Information:
Experience: 3-8 years
Location: Hyderabad / Secunderabad
Education: B.Pharm, M.Pharm, B.Sc, M.Sc, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job ID: 71985BR
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