Job Description
Position Description:
Responsibilities may include the following and other duties may be assigned.
Oversees, designs, plans and develops clinical evaluation research studies.
Prepares and authors protocols and patient record forms.
Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/
or offer a commercial potential.
Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with
standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare
clinical trial budgets.
May be responsible for clinical supply operations, site and vendor selection.
People working within region/country may also have the responsibilities that include:
Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local
customers and authorities.
Builds and maitains optimal relationships and effective collaborations with various internal and external parties.
Drives local evidence dissemination & awareness. - Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and
reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other
applicable regulatory requirements. - Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and
research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical
devices approval. - Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules,
preparing study documents, and issuing status reports.
May assist with design, development, and monitoring of clinical evaluation projects.
Trains investigators and site personnel.
Includes headquarter and field clinical research associates (CRA).
Implements and prepares the clinical development strategy as outlined by the clinical teams.
May contact and recommend qualified investigators to perform studies and initiate clinical trials.
Ensures recruitment and retention of patients.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty.
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to
colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the
projects from design to implementation - while and adhering to policies, using specialized knowledge and skills normally
acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach
to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work
group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas
or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis
provided is in-depth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information ofcomplex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain
input, and support decision-making.
Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in
Support Career Stream.
Must Have: Minimum Requirements Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a Bachelors degree and minimum of 5 years of relevant experience, or advanced degree with 0 years of experience. Minimum of 5 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
About Medtronic 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
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) Additional Information
- Posting Date: May 10, 2023
- Travel: Yes,
Employement Category:
Employement Type: Full time
Industry: Medical / Healthcare
Role Category: Bio Tech / R&D / Scientist
Functional Area: Not Applicable
Role/Responsibilies: Applied vacancy for Senior Clinical Research
Contact Details:
Company: Medtronic
Location(s): Bengaluru
Keyskills:
good clinical practice
clinical research associates
standard operating procedures
entry level
music making
project teams
problem solving
clinical trials
clinical research
corporate liaison
supply operations