Bayer MEDICAL RESEARCH ASSOCIATE (MRA) B.Pharma ,
B.Sc MS/M.Sc(Science) , M.Pharma
Job Description
WHAT YOU DO:
To be a key resource personnel in Medical Affairs concerning
Non-interventional 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 on-time and on-budget 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 the regular conference calls with the project
management, clinical operation team and other clinical team members
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 cross-functional teams
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