Job title: Clinical Research Manager
Company: Medtronic
Job description: MAIN PURPOSE OF JOB
Manages team of clinical professionals in India and Subcontinent (Bangladesh, Nepal, Bhutan, Maldives and Sri Lanka) across Medtronic’s divisions. May include team members from other regions.
Provides leadership for the conduct of clinical studies; Leads execution for both local and global studies, and clinical research projects over all of the Medtronic therapies across multiple businesses.
Reports to regional Clinical Research and Medical Science Leader
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
People Management
Leads and manages a team of individual clinical professionals and related staffs in his/her region.
Manages cross functional clinical study teams in accordance with the tasks linked to Clinical Research Manager and Study Manager roles.
Manages and coaches Clinical professionals and staff, including hiring, objective setting and appraisals mainly focusing on aligning projects (objectives, strategy, scope and schedule) according to and to meet business plans.
Clinical Projects Development and Execution
Develop clinical project/study and documents in collaboration with relevant stakeholders within Medtronic and oversee the execution in region.
Ensures appropriate resources and priorities are maintained for the projects assigned to the geography/country.
Has the ability to manage clinical research projects over all of the Medtronic therapies cross BU.
For global studies: Take up the role of local Clinical study Manager and Clinical Research Manager as assigned.
Authors/co-authors (or supports physician authorship) results of studies in the medical literature and/or presents at scientific meetings.
Internal Relations
Represents Medtronic as “the Clinical face” within the country / geography and acts at the same time as the “voice” of the local customers and authorities towards relevant stakeholders at Medtronic.
Assures successful & timely execution of assigned clinical programs consistent with clinical plans and applicable regulations and policies interfacing with representatives from key functional groups within Medtronic
Provides input to the local clinical strategy and ensures full alignment with the global clinical strategy
Identifies potential local clinical studies in line with local and Operating Unit (OU) strategy.
Develops and manages the study- and cost centre budgets.
External Relations
Builds and maintains a strong network with key-opinion leaders and relevant external stakeholders specific to the country/geography.
Ensures intake for investigator initiated research ideas and ensure appropriate follow-up within the organization through the relevant policy and SOP.
Be the first point of contact for:
Local customers, authorities and KOLs about local Clinical Affairs
Quality, Regulatory and Therapy Expertise
Assures that clinical studies meet highest scientific, statistical, quality and ethical standards.
Has working knowledge of India and regional Medical Device regulations, clarifies the interpretation with Regulatory Affairs Department and other regulatory bodies in countries when necessary.
Maintains a high level of professional scientific, technical and clinical expertise through familiarity with relevant literature, by attending scientific meetings and appropriate trainings, and by interacting with various inside/outside experts or departments/institutes.
Must Have: Minimum Requirements
- Master’s Degree in relevant Science or biomedical field (Medicine, Biomedical Engineering, Medical Physics, Medical Biology, Health Sciences, etc.)
- More than 8 years’ experience directly leading clinical research or similar experience in a medical/scientific area
- Ph.D. or MD (will substitute for 2 years of experience)
- 2 – 3 years’ experience managing people, budgets and clinical studies
SKILLS:
- People management skills
- Advanced written and oral communication skills
- Strong project management skills
- Ability to effectively lead remote teams
- Expertise with GCPs and regulatory compliance guidelines for clinical trials
- Good problem-solving skills
- Ability to think in the bigger picture of an organization
- Knowledge of clinical and outcomes research study design
- Finance and budgeting knowledge
- Demonstrated ability to work effectively on cross-functional teams
- Demonstrated ability to work in a matrix organization
- Strong business savviness and customer Focus
- Ability to collaborate with multiple internal and external stakeholders
- Experience managing KOL’s
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 31, 2022
- Travel: Yes,
Expected salary:
Location: Mumbai, Maharashtra
Job date: Thu, 02 Jun 2022 05:15:07 GMT
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