Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation, growth and high earning power.
Post : Medical Research Associate (MRA)
Job Description
• 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
Candidate Profile
• BSc / MSc / B.Pharm/ M.Pharm/ Life Science 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
Additional Information
Experience : 0 - 1 Years
Qualification : B.Sc./M.Sc./B.Pharm/M.Pharm
Location : Thane
Industry Type : Pharma
Last date : 10th June, 2020
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