Pharma jobs

R

Training&Quality Specialist @
Novartis - Hyderabad, Andhra Pradesh

Lead the development, coordination and implementation of training programs for Oncology Data Management personnel Ensure regulatory compliance and inspection/audit readiness within Oncology Data Management. Contribute as a member of the global DM Operations team. 1.Lead local training related efforts for Oncology Data Management function in alignment with global DM strategies, including development and delivery of courses and materials when appropriate, identification and coordination of SMEs and/or external trainers, and providing support and oversight to supervisory personnel to ensure role-based training requirements are met by their associates. 2.Work in collaboration with Global Oncology Education Office and global DM function leaders to identify appropriate training methods and recommend and develop training policies and procedures applicable to local associates, including induction/onboarding. 3.Collaborate/coordinate with global function training leaders in the development and/or periodic review/refinement of DM SOPs, Business Guidances, and other governance or instructional materials and delivery of training within Oncology DM, and when appropriate, to related line functions. 4.Perform ongoing analyses of the effectiveness of training delivered. 5.Ensure local training records are correctly logged, maintained and stored 6.Update and maintain course materials as required, ensuring global harmonization of content and sensitivity to local/cultural differences effecting local audiences. 7.Provide coaching and training to staff. 8.Assist in the collection and presentation of information related to periodic internal quality assessments and key performance indicators for Oncology Data Management. 9. Assist in periodic internal quality assessments to support all levels of personnel and assure continuous departmental audit readiness 10.Monitor adherence to standard practices and standards and achievement of quality ex-pectations, assisting in remediation if gaps occur. 11.Coordinate with global counterparts to drive audit readiness preparation and participate in audit related activities 12.Contribute to the continuous improvement of Oncology Data Management organization. Minimum requirements Undergraduate degree required in life science/healthcare related field. Advanced degree preferred Fluent English (oral and written) 1.At least 2-4 years previous experience in a training role 2.At least 4 years clinical/industry/health authority experience, preferably in Clinical Data Management 3.Knowledge in computer technology and ability to support company use of electronic data systems including Electronic Data Capture 4.Knowledgeable in computer validation and Part 11 requirements 5.Expertise in GCP Regulations. 6.Ability to work effectively in a team environment, in multiple roles 7.Strong written and verbal communication skills, effective negotiation and leadership skills 8.Effective training and facilitation skills 9.Good issue identification and problem solving skills including the ability to overcome obstacles and change resistance 10.Excellent organizational skills, with the ability to prioritize and work effectively in a constantly changing environment 11.Demonstrated ability to exercise good judgment and discretion when handling complex quality/compliance related issues