Work as Global Trial Leader in Novartis

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: Global Trial Leader

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Job Description:
Global Trial Leader (GTL) is accountable for planning, executing and to support reporting on global phase II-IV clinical trials from operational planning through trial close-out, in compliance with Novartis processes, GCP/ICH and regulatory requirements.

Major Accountabilities
1. Operationalize protocol
• Plan, facilitate and lead the global multidisciplinary Clinical Trial Team (CTT)
• Provide direct operational input into protocol development to ensure efficient and effec-tive delivery of trial objectives
• Communicate protocol information including changes or amendments to countries
• Create and implement an operational trial plan with line function support and stake-holder management with tracking to plan and updating as required
• Execute an operational risk management plan highlighting potential risks and actions.
• Foresee resource gaps and escalate in a timely fashion
• Create and drive trial level timelines
• Ensure all trial deliverables are met (i.e., budget) on time with quality
• Provide updates at relevant internal/external (as applicable) boards
• Prepare all relevant study related documents required for trial initiation with Clinical Scientist (CS)/Medical Lead and line functions to ensure availability of high quality de-liverables within specified timelines
• Develop trial level operational training materials for Clinical Study Manager (CSM), Field Monitor (FM) and sites

2. Manage Trial Allocation and coordination/management of activities leading to initiation of sites
• Accountable for assigned trial allocation to ensure optimal patient accessibility, re-source allocation, and country development.
• Create site screening tool for country feasibility, obtain approvals at relevant internal boards, and build allocation scenarios based on country feedback
• Accountable to write monitoring plan (including any tools and forms) and ensure CSM and medical input
• Collaborate with Medical Lead/CS and Integrated Information Sciences (IIS) to ensure relevant data capture tools are created and implemented as documented in data han-dling plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, di-aries, translations, edit checks)
• Plan, drive and facilitate multi-national investigator meetings or equivalent investigator training. 3. Prepare, Implement and Manage Vendors
• Accountable for vendor selection with appropriate CTT and outsourcing consultation
• Responsible for development of trial specifications (including user acceptance testing) with vendors and appropriate line function input to ensure the capture of quality data as per protocol requirements.
• Management of vendor start up, development of data specifications, and oversight of vendor activities and interactions during the trial, including.
- Efficient, quality-driven, timely execution of global clinical trials (i.e., best sites selected for a given trial, optimization of study start up, 100% of target enrolment at last patient first treatment, ) in compliance with international and local regulations and Novartis internal standards
- Data cleaning process is successfully accomplished within the required timelines across the trial with 100% clean data and no database unlocks
- Timely submission and delivery of high quality clinical trial documents to achieve critical milestones
- Proactive operational planning with effective contingency and risk mitigation plans
- Cost effective management of budget and resources with limited unforeseen cost.

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Candidate Profile
Bachelor’s Degree required; Fluent English (oral and written)
• Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical development process.
• Demonstrated ability to influence without authority
• Project Management experience preferred
• >3 years technical and operational experience in planning/executing/reporting clinical trials
• Excellent negotiation and conflict resolution skills
• Ability to collaborate across partner functions in a matrix environment
• Reproducible results in clinical operations
• Ability to work in a global cross-functional team
• Strong interpersonal skills
• Ability to work under pressure
• Resolve issues with supervision and understand when to escalate
• Demonstrated ability to effectively manage trial budget Document prepared

Additional Information:
Experience: >3 Years
Location: Hyderabad
Education: B.Sc, B.Pharm, any
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
Division: Pharma
Job Type: Full Time
Employment Type: Regular
Job ID: 173566BR
End Date: 15^th October, 2015