Merck KGaA

Specialist, Data Integration

Posted On

June 14, 2024

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

full-time

Apply By

July 2, 2024

Job Description

You will be responsible for consulting on the system development, administration and validation of Pinnacle 21 Enterprise, eClinical Solutions Elluminate, and potentially other Clinical Data RepositoriesDefine, review, and approve risk mitigation plans for GxP computerized systems to ensure compliance with regulatory standards.Lead and manage the validation efforts for all computerized systems used in GxP processes (Mainly : Pinnacle 21E and eClinical Solutions Elluminate , including authoring validation documents and test scripts.Ensure that the technical requirements for system validation are documented and implemented effectively.Collaborate with cross-functional teams to align system validation activities with business processes and user requirements.Champion the system during user acceptance testing (UAT) and ensure that the system is fit for its intended use.Implement and maintain procedural controls to uphold the validated state and protect data integrity.Conduct evaluations for go/no-go decisions on change requests affecting security, maintainability, and data integrity.Coordinate with vendors and internal stakeholders to ensure the successful validation of all GxP systems.Provide subject matter expertise on validation processes and regulatory requirements to support the overall system validation strategy.Independently performing system administration tasks for Pinnacle 21 EnterpriseCleanup and enhancement of existing Pinnacle 21 Enterprise Processes including Business Operations ManualUser / Admin ManualsOperative action in respect to the setup of users and the user management processPerform the further development of and performing system administration tasks for a Clinical Data Repository (eClinical Solutions: Elluminate)Users and system Administration for DMMI systems : Set-up of studies, and instances, creation/deletion of users account, users supportContributions to processes and technical frameworks to improve the operations of the listed systemsCollection and consolidation of documentation in agreement with all applicable regulationsCapabilities/KnowledgeExcellent self-organizational and time management skills are required. Attention to detail is essential.ICH-GCP, Computerized Systems Validation, and Operational Aspects of System Management (user management, etc…) related background knowledge is an assetKnowledge of Clinical Data Management related topics, proficiency with data management systems such as Clinical Data Repositories, Pinnacle 21 Enterprise is a mustExcellent command of English language (verbally and in writing); other language(s) is a plus.Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences) or equivalent work experience.Extensive experience in validation processes within a GxP-regulated environment, preferably in the pharmaceutical, biotech, or medical device industry.Strong understanding of regulatory standards such as GxP, GAMP 5, and FDA guidelines.Proven ability to lead and manage validation projects, including authoring validation documents and test scripts.Excellent communication and interpersonal skills with the ability to collaborate effectively with cross-functional teams.Who you are: Degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals), and 6-8 years industry experience We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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