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Manager Trial Mgmt

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

The Manager-Trial Management (TM) coordinates global Drug Supply Management (DSM) trial activities including planning and study set-up. As business partner in the CTT (Clinical Trial Team) DSM TM defines and advises the Clinical Team on the optimal study supply strategy in terms of packaging design, technical and timely feasibility, cost efficiency and risk limitation. The DSM TM is also responsible to provide over time complete and accurate demand figures (volume, timeframe, final product description) to the DSM Supply Chain Manager (DSM SCM)1. Establishes, manages and communicates clinical supply plans, timelines and packaging solution with internal and external customers and partners 2. Represent DSM as an active member of the CTT, ensuring clear communication and alignment between clinical needs and supply plan 3. Reviews clinical trial protocol and provides input to drug sections. Develops packaging design matching the study design, which ensures optimized supply plan in terms of cost, feasibility and overage 4. Leads packaging design optimization 5. Creates reviews and updates the demand plans based on changes in strategic elements / study forecasts. 6. Liaises with Clinical Supply Documentation Specialist (CSDS) to define optimal label strategy ac-cording to study design HA regulatory requirements 7. Coordinates the randomization of clinical supplies 8. Performs medication management and coordinate the distribution of clinical supplies for non-IRT trials 9. Plans budget for associated external costs for booklet labels, IRT & medication management and distribution until assignment of other DSM roles to study. 10. Is accountable for creating CPRs (Clinical Packaging Request) with good quality (FTR) 11. Timely communicates and updates the clinical demand plan on study level to DSM Supply Chain Managers and ensure seamless coordination of demand and supply 12. Identify, assess and flag risks on a study level to stakeholders, define and communicate accordingly mitigation plan/strategy to appropriate boards (CTT, CDPM, Portfolio Review Meeting, ) 13. Supports internal/external inspections and audits 14. Actively contribute to SOP creation, revision and update 15. Ensure that own deliverables are met. 16. Coaching and technical training as recognized technical expert or leader. 17. Act as mentor for junior and senior associates. 18. Support cultural evolution within own function by showing positive work ethics and influencing others. 19. As process owner being accountable for process improvement.Minimum requirementsDegree in science, engineering or equivalent Fluent in English 1. >5 years of practical experience in chemical / pharmaceutical/ clinical operations/drug development industry or > 5 years of experience in field of expertise 2. Good expertise in related field. Good (IT) application know how. 3. Good knowledge about the Drug Developmengt process 4. Basic project management , good organization and planning skills 5. Knowledge of relevant regulations (e.g. GMP, HSE etc.) and Novartis specific standards. 6. Demonstrates problem-solving and idea generation skills 7. Good presentation skills 8. Fundamental Leadership skills. 9. Good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams
Additional Degree: B.Sc. (Science)

Experience: 5-10


Clinical Research | Data Management/ Statistics | Drug Regulation
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