343432BR
Apr 08, 2022
India

Job Description

GCS Clinical Trial Supply Manager (CTSM) defines and executes an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients. The CTSM is the GCS single point of contact at trial level for the integrated Clinical Trial Team (iCTT). Is responsible for clinical trial supply deliverables within GCS and all other relevant associated sub-func-tions, maintaining Quality and Compliance through all activities. Execute and monitor timely activities related to assigned area of responsibility under the guidance and accountability of more senior associates.

Your responsibilities include, but are not limited to:

• Represents GCS as a core member in the integrated Clinical Trial Team (iCTT); defines and advises the iCTT on the optimal clinical trial supply strategy in terms of, but not limited to, pack-aging design, technical and timeline feasibility, efficiency and risk management. Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule.
• Creates and maintains complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate overage and by using defined processes and systems.
• Creates and drives finalization of the packaging design (Clinical Packaging Request) and a com-prehensive label strategy for all participating countries in the clinical trial. Defines clinical supply parameters for NIRT set up and initiates subsequent updates throughout the duration of the clinical trial. Develops and executes a trial-level project plan together with all other relevant roles.
• Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity.
• Collaborate with all relevant line function partners for country submission and approval time-lines (including IND-IMPD amendment) to develop optimal supply strategy.
• Generates optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions. Triggers and tracks shipments of IMPs from central depot to regional hubs and local depots.
• Develops, maintains and executes an optimal resupply strategy with proactive planning, appro-priate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.
• Is responsible to consolidate, maintain and track the clinical trial budget with key stakeholders for overall GCS external cost (e.g. labels, packaging, distribution and comparators). Actively contributes to the GCS subteam as a full member. Ensures adequate, proactive ex-change of relevant knowledge & information between the GCS sub team and the CTT. Fully supports, prepares the GCS PL to adequately address GCS-considerations at various cross-functional teams e.g. TRD sub team, ICT, etc.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• >2 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise
• Apprenticeship or formal education in a logistical, technical or related business area
• Basic project management , good organization and planning skills
• Good knowledge of HSE/GMP standards and processes
• Problem-solving and idea generation skills
• Good presentation skills, Fundamental Leadership skills.
• Good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams

WHY NOVARTIS

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
TECHNICAL R & D GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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343432BR

Associate Clinical Trial Supply Manager

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