Clinical Research Spec Jobs Vacancy in Medtronic Hyderabad
Medtronic Hyderabad urgently required following position for Clinical Research Spec. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Clinical Research Spec Jobs Vacancy in Medtronic Hyderabad Jobs Details:
Careers that Change Lives
Represents Medtronic Clinical Affairs internally and externally for Indian Subcontinent.
Manage local evidence plans in light of market needs, changing local environment and competitive evidence landscape.
Acts as an extension of the business units (SBU or BU) and Medtronic Engineering and Innovation Center (MEIC) in the country to successfully facilitate clinical trials execution. Performs activities for either a specific therapeutic area or across several therapeutic areas.
Combines Clinical solution expertise and local market knowledge to drive local clinical execution and best healthcare solutions.
A Day in the Life
Country Clinical Affairs:
Actively builds and maintains optimal relationships with local customers and local Key Opinion Leaders as well as with local authorities, medical & scientific communities and the medical device industry focusing on the assigned therapeutic areas
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
Establish effective and systematic collaboration with relevant internal stakeholders, physicians and hospitals and trigger the conversation locally around value-based healthcare, outcome measurement and improving quality of care
Set up a database of potential target accounts to be engaged in clinical activities in the country.
o Conduct field visits and initial assessments for identified leads. Build and present proposals in collaboration with the relevant internal teams
Supports and provides input to the local clinical strategy and ensures full alignment with the global clinical strategy for each SBU.
Identifies potential local clinical studies in line with local and SBU strategy and submits potential study proposals to the clinical SBU for approval
Define and map internal, external and environmental barriers and develop plans to address them in a methodical way
Build the right level of knowledge in reimbursement, health management in the country/region to address those with relevant clinical solutions.
Be the first point of contact for:
• Local customers, authorities and KOLs about local Clinical Affairs
• MEIC R&D: to develop and execute research feasibility and pre-market studies to full fill the product development and regulatory requirements
• Clinical BU: for in-depth knowledge about the local clinical environment and for mandatory consultation on site nomination
Is the point of contact for:
• Clinical BU: to approach local market for globally initiated studies
• All departments in Medtronic that need access to the local clinical field
• Other clinical execution groups at Medtronic as Post Approval Network, (PACS) or MC2 (Medtronic Clinical Operation and Regional Clinical Center) in case of local knowledge needs (language, culture, travel)
Facilitating quality audits, safety, legal (contracts), potential studies (MEC) and medical writing
Support in Study Management, Study Execution and ERP:
Ensure seamless project execution and high quality deliverables that meet stakeholders’ expectations
Medtronic global studies facilitation, study management for local studies
• In case needed, takes care of study management for local studies at the request of the BU clinical team and Performs Country Clinical Project and Research activities as required
• Coordinates with investigators the External Research Program (ERP) submission, tracking, and local administration all in alignment with existing SOP’s.
• Forwards approved local studies to the clinical BU, PAN, MCO and / or RCC for execution and facilitates the access to other departments (such as Regulatory, Quality, Reimbursement), Authorities and Ethics Committees
• Manages local study activities, for instance
o Contract Set-Up
o Non-device related Complaint handling
o Coordination of communications and activities as needed between local and central groups for Safety Reporting
o Cross functional alignment in the contractual activities
• Provides local expertise to support studies on:
o Review budget / timing and effort estimates to ensure they adequately reflect the local environmental practices and constraints
o Data protection, local laws, reimbursement etc
o SOP compliance
• Support the monitor as needed for the EC submission and the CA and RA submission
• Develops expert knowledge by training study teams and MDT colleagues and external individuals as needed
• Liaises between Global study teams, scientists, Clinical Executives and KOLs. Also liaises between MC2 / Clinical BU and Country (collect competitor intelligence, relay of study ideas to BU…)
• Ensure technical support for specific Pre-approval studies if needed
• Attends the “study team” meetings as needed
Local evidence dissemination & awareness:
• Ensures awareness of local clinical activity and new clinical evidence and provides input to sales & marketing leaders
• Advises local marketing organization on outcome of publications and advises on a communication strategy
• Ensures strict adherence to regulations and communicates discrepancies to the different stakeholders
• Provides expert review of marketing / sales presentations, literature and publications
• Provide clinical evidence dissemination to internal stakeholders
• If needed, provide clinical evidence for supporting tenders
Must Have – Minimum Requirements
- University Masters or Bachelor’s degree in relevant technical, engineering, clinical or biomedical field.
- 5 years of experience in clinical or R&D background
- Deep knowledge on the local culture and language
- General knowledge of ‘Good Clinical Practice’ and applicable regulations
Nice to Have · Ability to influence without authority and collaborate and communicate at ease across the organization and hierarchies to achieve desired objectives
· Professional presentation and "Presence"
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. 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.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.