14 Feb

Clinical Research Spec Jobs Vacancy in Medtronic Hyderabad

Position
Clinical Research Spec
Company
Medtronic
Location
Hyderabad TS
Opening
14 Feb, 2018 30+ days ago

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:

Sr. Clinical
Research Specialist

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"

PHYSICAL REQUIREMENTS:
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.

ABOUT MEDTRONIC

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.


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