Medical Research Associate

3 months ago

Thāne, Maharashtra, India Bayer Full time

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Medical Research Associate

YOUR TASKS AND RESPONSIBILITIES:

  • To be a key resource personnel in Medical Affairs concerning Phase IV and Noninterventional study (NIS) activities across all business areas.
  • To coordinate all study activities like CRO selection, preparation of study documents for review, site selection and site feasibility, update relevant tracking systems on an ongoing basis, implement quality checks especially for outsourced studies and manage clinical trial oversight, manage study budget and required resources, site monitoring and quality review and archival. The major responsibility includes ontime and onbudget study completions in India.
  • To manage all operational and quality aspects of allocated studies in compliance with ICH GCP.
  • Responsible for the implementation and training of standardized processes within the study and according to organizational SOPs.
  • Development of essential studies as per the local requirements and creating the essential documents like protocol, ICF etc with coordination of global/local team.
  • Ensures that essential documents quality meets the expectations of Regulatory requirements in India and Bayer guidelines and SOPs.
  • To attend regular meetings and conference calls with project management, operation team and other team members, regional and global teams as required.
  • To communicate regularly with all other related departments to ensure timelines, resources, interactions and quality are maintained.
  • To prepare and monitor clinical activity timelines and metrics.
  • To ensure regular project review, using tracking and management tools, implementing appropriate recovery actions to ensure project timelines are met.
  • Responsible for the resolving the quality issues of outsourced studies.
  • To provide regular status updates to the project team and related business crossfunctional teams.

WHO YOU ARE:

  • Qualification: graduate
  • Relevant clinical research experience in a pharmaceutical company/CRO with a good understanding and experience in handling clinical studies in line with ICH-GCP guidelines.
  • Ability to work independently as well as in a team environment and to build productive work relationships both internally and externally
  • Fluent in English with good presentation and written and verbal communication skills

YOUR APPLICATION

Location:

  • India : Maharashtra : Thane
    Division:
  • Pharmaceuticals
    Reference Code:

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