Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post: Change Manager
Job Description:
- Convert clinical information (inputs provided by study group) into technical information and forward to the EDC vendors in order to implement changes.
- Analyse the validity of change request and alternate options for mitigation (OC discrepancy, listing, derivation outside of EDC).
- Perform user acceptance testing for all related systems and interfaces Ensure functioning of CDMS mapping as per the specifications. Support CRF update - including eCRF mock up.
- Define and update electronic data transfer from external data sources (TSIR, lab specification).
- Coordinate the setup of data entry screens and preparation of data entry guidelines. Ensure data base setup, annotations and blinding initiatives. Ensure build of interfaces from CDMS to other systems.
- Update and approval of validation and derivation procedures.
- Ensure adherence to data review process (data flow agreements)
- Proactively follow up on CROs/vendors for fulfilling the contract; and take action in case of divergence from the contract
- Ensure active involvement of team members, stakeholders and cross project colleagues during planning phase of the projects
- Remain knowledgeable and updated on the goals and the purpose of projects, and ensure appropriate communication to relevant stakeholders.
- Review documents from a data management perspective with reference to Novo Nordisk procedures and instructions.
Candidate Profile:
1). M.Sc / B.Sc in Life Science or comparable degree in computer science, Information Technology, Clinical Research or equivalent qualifications.
2). Minimum 2-4 years of experience working with pharmaceutical industry and preferably 2 years’ experience in site activities, data management, system support or related areas.
3) General knowledge of computer systems and IT.
4) Knowledge of analysis and design of business processes and functional design within the area of drug development.
5) Knowledge of validation of computer systems.
6) Experience with project management.
Additional Information:
Experience: Min 2-4 Yrs
Location: Bangalore
Education: M.Sc, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Biostatistics and Data Management
End Date: 30th August, 2016
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