Opening for Manager Trial Management @ Novartis
Job Description :
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
Candidate Profile :
Degree 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.
Experience: >5 years
Qualification: Degree in science
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
Job ID: 190547BR
Last Date: 25th November, 2016
To apply, Click here.