Job Description:

Location: Northridge, CA

Careers that Change Lives

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market.

The Associate Clinical Research Specialist (ACRS) supports the planning and conduct of clinical studies and ensures compliance to the study protocol, ICH-GCP guidelines, applicable regulatory standards, and Medtronic Standard Operating Procedures. This position will be supporting the in-house clinic and handling various clinical study assignments, and collaborating with cross-functional colleagues in resolution of strategic and operational issues.

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 maintains optimal relationships and effective collaborations with various internal and external parties.


• Drives local evidence dissemination & awareness.

The ACRS will assist with:

• clinical activities related to one or more clinical studies and performing/managing the daily field operations associated with support of the assigned studies.


• study management duties for assigned clinical programs to evaluate performance, safety, and efficacy of products and to satisfy applicable regulatory standards and Medtronic internal requirements for regulated clinical studies (domestic and international).


• responsibility for site management activities such as collecting, reviewing, and tracking essential documents, reviewing the data, and ensuring site compliance.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Come for a job, stay for a career.

DIABETES GROUP

Medtronic Diabetes is focused on transforming diabetes care for better freedom and great health, serving patients across the continuum of diabetes. Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.

Transforming diabetes care together, for greater freedom and better health.

Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.

Must Have: Minimum Requirements

To be considered for this role, the minimum requirements must be evident on your resume.

• Bachelor's degree required


• 0 years of experience required

Nice to Have (Preferred Qualifications):

• Degree in engineering, life sciences, or related medical/scientific field.


• 
  Clinical Research experience at Medtronic Diabetes or within a medical device industry.


• Experience with Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.


• Ability to incorporate and adhere to good clinical practices and regulatory standards.


• Experience in:




• managing multiple clinical research sites with proven results in study execution, clinical trial data review, clinical monitoring functions and clinical research methodologies, including study design, implementation and reporting.


• international clinical trial management/data review, trial design and biostatistics.




• Experience with Clinical Operations and interfacing with CRO teams. Demonstrated ability to work effectively on cross-functional teams. (Including R&D, Marketing, Operations).


• Project Management experience. Proficiency with writing reports, business correspondence and procedure manuals.


• Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.


• CCRA certification (Certified Clinical Research Association), CDE (certified diabetes educator) or equivalent preferred.


• Basic understanding of biostatistics and trial design.

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 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 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).

Candidates must be able to work flexible hours that may include working occasional weekends or evenings.

Ability to travel up to 25% (including extended air travel) domestic and international.

Check out benefits.medtronic.com

Additional Information

• Posting Date: Nov 24, 2020
• Travel: Yes, < 25 % of the Time

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