Job title: Clinical Research Specialist- Hyderabad
Job description: Careers that Change Lives
Be a part of a community of experts committed to ensuring quality, affordable care around the globe. This opportunity will help you become a part of the team which partners with the industry to make healthcare more affordable and accessible. 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.
Impact patient outcomes. Come for a job, stay for a career !
A Day in the Life
- 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
Must Have: Minimum Requirements
- Bachelor’s degree with minimum 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) but preference given towards clinical research background
Nice to Have
- 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
Together, we can change healthcare worldwide. 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. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
- While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.
- Ability to travel ≤30% of the time
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
- Posting Date: Mar 14, 2022
- Travel: No
Location: Hyderabad, Telangana
Job date: Wed, 16 Mar 2022 01:56:03 GMT
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