Job Title: Training Consultant (Clinical Research)
Location: Japan (Hybrid)
Job Description:
Primary Role & Responsibilities
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Responsible for customizing and delivering trainings to our global pharmaceutical customers over various domains in the healthcare vertical.
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Deliver full day class room based training sessions or connect online via Virtual trainings.
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Work with customer, acting as the SME for course material design with responsibility of customizing and delivering corporate trainings/training modules as per the requirements.
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Serve as performance coach through consulting, monitoring and evaluating training results in the work environment and classroom delivery responsibilities.
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Responsible for understanding profile of attendees, classroom preparation, classroom setup and evaluating the success of the learning programs and solutions.
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Should have excellent presentation skills and zeal to explain the minute technical details in easy way to the participants.
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Works with the delivery manager to provide feedback on class delivery and associated resources.
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Ensuring constant learning process to stay abreast in relevant technologies.
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Independently establishes work priorities and direction with minimal input from other team members and management.
Technical Competence:
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A Bachelors graduate in Pharmaceutical Science with familiarity working on clinical trial master file documentation, data management, clinical operations and pharmacovigilance.
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Excellent communication and organization skills coupled with through knowledge of ICH-GCP and essential documents involved in clinical trials and regulatory.
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Familiarity with systems like Oracle Clinical, OC-RDC, RAVE, Inform
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Knowledge of different software to file documents electronically like right track, GDMS, ELARA, ELVIS etc. would be preferred.
Non-Technical Competence:
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Innate ability to share information
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Excellent written and verbal communication skills including good facilitation skills, excellent presentation skills and engaging presentation style is necessary.
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He /She should be a good motivator, with lot of energy and enthusiasm with a proven ability to learn quickly, multi-task and work independently as well as part of a team.
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Must be able to stand and lecture long sessions at a stretch.
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Willing to travel exclusively on domestic as well as international sectors
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Should be open to learning new technologies and cross-domain competence flexibility
Professional Experience & Competence:
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8 - 10 Years of Sr CRA experience
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2-3 years of Line Management or Project Management
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Excellent Communication (Japanese & English)
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Soft skills awareness
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Clarity on ICH-GCP Guidelines, specifically Essential Documents.
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Practical Exposure to maintenance of Investigator and central file.
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Perform source data verification, and reconciliation of adverse events for market research programs.
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Familiarity and/or experience with electronic Trial Master File systems (eTMF).
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Familiarity and/or experience in defect tracking and reporting using Clinical Data Review System & manual tracking.
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Ability to convey SOP requirements theoretically and practically.
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Industry certifications pertaining to technical areas and/or training will be highly appreciated.
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Someone with regulatory background would be an added advantage.
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8 - 10 Years of Sr CRA experience.
Rewards:
Opportunity to explore, specialize and research on various phases of clinical research like clinical data management, Pharmaco-vigilance, Biostatistics and Medical Sciences, while executing various program-based cohorts and project specific workshops.
NIIT Ltd facilitates an open platform for career growth wherein you can research in your areas of interest and excel in your career. Sponsorships for Industry certifications to further enhance your domain expertise are also provided by the company.
NIIT Ltd offers pay package that are best as per industry standards and recognition to your achievements. NIIT is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.