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Sr Medical Research Associate 

 

POSITION PURPOSE:

Senior Medical Research Associate is key resource personnel in Medical Affairs for managing and executing Phase IV studies (including Post marketing surveillance studies, Non-interventional studies (NIS), mandated Phase IV studies including interventional post-approval trials) activities across all business areas. He/She is responsible for all operational and quality aspects of the allocated studies in compliance with ICH-GCP, local regulations and within the agreed timelines and cost.

YOUR TASKS AND RESPONSIBILITIES:

As Individual contributor:

To Coordinate all study activities like CRO selection, preparation of study documents for review, site selection and feasibility, update relevant tracking systems on an on-ging basis, implement quality checks especially for outsourced studies and manage clinical trial oversight, manage study budget and required resources, site monitoring, quality review and archival. The major responsibility includes on-time and on-budget completions in India.To have an oversight on CRO partners for outsourced studies by conducting oversight quality visits at sites if applicable, conduct regular meetings and seek regular updates on study progress.Organize Investigators meetings if applicable, conduct site feasibility visits and site initiation visits if applicable to ensure that the study staff are well trained and familiar with the protocol and study procedures.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 requirement and creating the essential documents like protocol, ICF etc with coordination with global/local team members.Ensures that essential documents meet the quality expectations of regulatory requirements in India and Bayer guidelines/SOPs.Reports and/or communication with Health Authority/IRB/Investigators and global/country study team, marketing/sales departments to update and share study progress, protocol, safety and other issues where necessary and submit annual-bi-annual report to regulatory teams in order to meet local requirements.To provide efficient and timely study updates to Manager Medical Operations.

WHO YOU ARE:

A Qualified pharmacy or science/life-science graduate/ postgraduate.Desirable previous experience of around 5 years in clinical research.Strong skills in managing stakeholders and good understanding of handling clinical trials in line with ICH-GCP and local regulations.Business Acumen displaying ability to operate cross-functionallyPersistent in approach, drives objectives despite setbacksAdEopts an optimistic outlookCollaborates effectively, team player, team leaderInquisitive mindset, challenges status quo, proactive in approach.

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  YOUR APPLICATION   

Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.

 

   Location:India : Maharashtra : Thane    Division:Pharmaceuticals   Reference Code:851646     Contact Us + 022-25311234