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: Trial Account Manager
Job Description:
Works with primary account manager for Clinical Trials Portal (CTP) Interactive Response Technology (IRT) and ClinAdmin supporting the Clinical Franchises, Translational Medicines (TM), Oncology and other businesses as needed.
Second tier liaison between Development Informatics and members of the business organization (Country Organization (CPOs), Drug Supply Management (DSM), Development Strategic Sourcing (DSS), Statistics and Data Management and Clinical Quality Assurance (CQA) to ensure the business needs of the end users (Clinical Trial Teams/Investigator sites, etc.) are met.
Major Accountabilities
• Partners with and supports Sr Trial Account Manager on portfolio of new and maintenance trials.
• Ensure compliance with all required SOPs and business guidances.
• Supports continuous improvement and other management objectives.
• Works with primary account manager to evaluate planned trials as potential candidates for IRT; assess risks, costs and benefits of utilizing IRT
• Supports the development, initiation, maintenance and close-out of IRT
• Contributes to completing SSW/Decision Grid as required
• Participates in the review and preparation of overview of costing proposal from vendors
• Supports the CTT/DSM in the selection of the preferred provider, User Requirement Specifications (URS) and other relevant activities for IRT initiation
• Plans, performs and documents user acceptance testing (UAT) of all systems including report facilities with support of CTT prior to system going live
• Leads management of study-specific IRT issues, including identification, escalation, resolution and closeout.
• Tracks approval of related documents and provides updates as needed
• Tracks usage of systems and provide reports as required
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Candidate Profile:
Minimum of a Bachelor’s degree in a relevant field, such as a scientific or health care discipline.
6+ years working experience and good knowledge of the drug development process, specifically clinical trials.
Good knowledge of GCP, GMP and FDA part 11
Knowledge of clinical trial design and basic statistics
Familiarity with clinical trial systems
Understanding of technology and tools
Good understanding of clinical development and clinical operation processes.
Ability to work in a global team and matrix structure organization, meet timelines and work with minimal supervision.
Ability to influence without authority
Great attention to accuracy and detail.
Strong team player
Good communication and presentation skills
Additional Information:
Experience: 6+ years
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 195677BR
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