Work as Assoc Clinical Research Specialist at Medtronic

At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

Post : Assoc Clinical Research Spec

Job Description
• Provides all aspects of executional support for Clinical Research Projects/studies in India and Subcontinent countries as assigned
• Performs activities for either a specific therapeutic area or across several therapeutic areas.
• Management of global and local clinical studies in Clinical Research Specialist role and execution of clinical projects as required
• Provide operational support to clinical studies which includes but not limited to
- Ethics Committee (EC) submissions and communications
- Contract negotiation and execution support
- Site management
- Manage site and study team communications
- Study document management and filing
- Data queries resolution and follow-up with sites

• Provide technical support:
- to the monitor as needed with site training, query resolution, escalation, documentation review etc
- to hospitals for clinical studies execution and data collection
- to vendors
• Support Clinical Study Manager in management of Core Lab activities
• Support safety team in set up and management of Clinical Events Committee and adverse event adjudication and reporting processes
• May be present in the hospital during medical procedures as well as physician office to facilitate patient testing and data collection
• Coordinates with investigators for the External Research Programs (ERP) submission, tracking, and local administration all in alignment with existing SOP’s.
• Support the monitor/Clinical Trial Assistant (CTA), as needed, for the Ethics Committee (EC) submission, site start up and the Competent Authority (CA) and Regulatory Authority (RA) submission
• Attends and/or conducts the “study team” meetings as needed
• Develop therapy knowledge in assigned OU’s and build relationship with Key Opinion Leaders
• Represents Medtronic as “the Clinical face” within the country / region and acts at the same time as the “voice” of the local customers and authorities towards relevant stakeholders at Medtronic for the assigned therapeutic areas
• Drives local evidence dissemination & awareness.
- Actively disseminate clinical research evidence as assigned
- May help develop key messages and materials to be used across the organization for a particular clinical research program

Candidate Profile
• Bachelor’s degree with 1-2 years’ relevant experience in clinical research, hospital, engineering, or medical devices
• Open to candidates with experience in sales/marketing/training with relevant science-based degree (BSc, BTech, BE, BPharm, etc) and an inclination towards clinical research
• Experience in the management of medical devices
• Experience in a cath lab, biomedical engineering, hospital/clinic or medical sales
• Ability to work with many different stakeholders from varying backgrounds
• Affinity towards clinical research, good clinical practices, processes and regulations
• Strong judgment & interpersonal skills

• Proven to be decisive
• Strong problem solving & influencing skills
• Strong oral and written communication skills in local language and in English
• Quality and compliance focus; attention to detail and accuracy following quality and compliance polices and good documentation practices
• Models the highest standards of honesty, ethics, and integrity
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Professional presentation and "Presence"
• Ability to cultivate relationships with co-workers in a cross-functional environment, collaborate within team and with other teams for executing clinical studies
• Strong time management skills; ability to identify and adapt to shifting priorities, work with a sense of urgency to deliver results in a time bound manner

Additional Information
Experience : 1-2 years
Qualification : BSc, BTech, BE, BPharm
Location : Bangalore, Karnataka
Industry Type : Clinical
End Date : 30th May, 2021