19 days old

Sr Clinical Research Specialist

Medtronic
New Haven, CT 06532
Sr Clinical Research Specialist

Location:

New Haven, Connecticut, United States

Requisition #:

19000MSK

Post Date:

Nov 15, 2019


**Careers That Change Lives**


This role is part of the clinical research team supports new product development, life-cycle support, and product adoption by developing clinical evidence strategies. This position is responsible for maintaining compliance across all sites in the clinical strategy organization. This person will be responsible for maintaining the required training curricula, tracking compliance to the required training, supporting clinical/ regulatory audits and deficiency responses, serving as a group representative for CAPA responses.


**Impact patient outcomes. Come for a job, stay for a career.**


The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.


**SURGICAL INNOVATIONS** sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.


**A Day in the Life**


Responsibilities may include the following and other duties may be assigned.


+ Managing and assigning training curriculum appropriate to the site and the role.

+ Track data and metrics related to training and compliance

+ Serves as a representative for audits and Corrective and Preventative Actions (CAPA) including collaboration with cross-functional partners to ensure preparedness for audits, timely responses to deficiencies and CAPAs

+ Maintains understanding of regulatory requirements across multiple regions; serves as resource for clinical strategy personnel

+ Serve occasionally as lead on responses to deficiencies for products

+ Liaise with site leads to ensure appropriate level of support for ongoing compliance and training related activities

+ Maintain and generate tools to facilitate

+ Potential for ownership of process improvement efforts and workstreams


**Must Have: Minimum Qualifications**


+ Bachelors degree required.

+ Minimum of 4 years of clinical research experience, or advanced degree with a minimum of 2 years of clinical research experience.


**Nice to Have**


+ Experience in medical device and/or pharmaceutical industry, preferably in regulatory, clinical research, or product development

+ Tactical experience regulatory deficiencies, audit preparedness, regulatory response

+ Proven success building out tools, processes and instructions to maintain compliance

+ Experience in understanding and maintaining compliance to regulations, building compliance into effective processes

+ Applies analytical and problem-solving skills with support; ability to identify problems with guidance and make suggestions for resolution

+ Ability to coordinate multiple projects simultaneously

+ Ability to establish priorities independently and work under tight deadlines

+ Demonstrates desire to learn and shows initiative

+ Ability to mentor and cross-train colleagues, support others, generate ideas and take on increased responsibility with minimal support

+ Able to identify areas for self-training and development needs


**Physical Job Requirements**


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.


The physical demands described within the Day in the Life 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.


**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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


**EEO**


It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:http://www.uscis.gov/e-verify/employees
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2019-11-19 Expires: 2019-12-26

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Sr Clinical Research Specialist

Medtronic
New Haven, CT 06532

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