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 : Manager Trial Management
Job Description :
The DSM Trial Manager (TM) plans, drives and coordinates global Drug Supply Management (DSM) activities on a trial level during study set-up, as well as for non-IRT studies during trial conduct, to ensure the right drug always gets to the right patient on time. As business partner in the CTT (Clinical Trial Team) the TM defines and advises the CTT on the optimal study supply strategy in terms of packaging design, technical and timeline feasibility, cost efficiency and risk management. The DSM TM is also responsible to provide complete and accurate clinical trial demand information using defined DSM processes and systems.
1. Coordinates trial deliverables within DSM and all other relevant associated functions. Ensures that a trial-level project plan is developed together with all relevant roles and progress of deliverables adequately tracked. Maintains proactive communication with internal customers such as CDM, SCM, OM, CLM and MDM on trial changes and progress of deliverables.
2. Represents DSM as an active member of the CTT, ensuring clear communication and alignment between clinical needs and clinical supply planning.
3. Identifies, assesses and communicates risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity for all patients.
4. Reviews clinical trial protocol and protocol amendments and provides input to drug supply sections. Develops optimal packaging design to match the study design and a supply plan optimized for cost, feasibility and overage.
5. Creates clinical demand plan for a trial based on trial requirements and maintains an accurate clinical demand forecast with appropriate overage based on changes in trial parameters.
6. Liaises with Clinical Supply Documentation Specialist to define an optimal label strategy according to study design, study timelines, participating countries and regulatory requirements.
7. Creates and drives finalization of Clinical Packaging Request.
8. Coordinates the randomization of clinical supplies. For non-IRT studies (applies to items 9 to 12):
9. Generates optimal distribution plans for investigational medicinal products considering aspects such as optimal lot size, costs and overages.. Triggers and tracks shipments of clinical trial supplies from central depot to regional hubs and local depots. Follows-up with distribution vendors and local hub/depot contacts, as needed.
10. Defines optimal shipping lot size per hub/depot considering distribution costs vs. material cost, overage, shipping lead times and overall CPO clinical supply needs.
11. Creates and executes an optimal resupply strategy.
12. Manages shelf life planning on clinical finished good level and extensions of expiry dates and executes against plan to ensure supply continuity.
13. Actively participates in TM Forums activities and meetings, and supports TM Forum Lead as required
14. Supports internal/external inspections and audits
15. Actively contributes to SOP creation and revision
1. Adherence to quality, quantity and timelines for all assigned tasks/projects.
2. GMP Compliance (number of deviations, technical issues, audit / inspection findings).
3. Adherence to Novartis standards and Values & Behaviors, in particular, quality, ethical, health, safety, and environment standards (HSE), and information security standards (ISEC).
4. Assigned individual and team objectives
5. Unit KPIs (e.g. FPFV (first patient first visit), LTA (lost time accident), FTR (first time right), Rework Rates, Recalls). Cross-functional KPIs.
6. Measurable contributions to efficiency and productivity increase.
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Candidate Profile :
Advanced degree in pharmacy, science or relevant discipline (M. Pharmacy / M.Sc. / MBA or Equivalent) Fluent in English (Read, Write and Speak)
1. >5 years of practical experience in clinical operations/ pharmaceutical industry
2. Sound knowledge and understanding of Global Drug Development.
3. Sound project management experience (PMP certified preferred).
4. Experience in SAP/IT application savvy.
5. Strong knowledge of relevant regulations (e.g. GMP, GCP, HSE etc.) and Novartis specific standards.
6. Strong communication and presentation skills..
7. Excellent organization and planning skills.
8. Must have ability to work in interdisciplinary and cross-cultural teams.
9. Proven results in operational excellence are
Additional Information:
Experience: >5 years
Qualification: Degree in pharmacy, science
Industry Type: Pharma/ Healthcare/ Clinical research
Location: Hyderabad
Functional Area: R&D
Job ID: 203110BR
Last Date: 25th January, 2017
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