Senior Clinical Research Specialist

Careers that Change Lives

Medtronic has a great opportunity available for a Senior Clinical Research Specialist for the Irvine-based Neurovascular business. Will provide functional expertise, leadership, support, and assistance to management and cross functional teams to achieve business goals and objectives.

This Senior Clinical Research Specialist role includes, but is not limited to, ensuring proactive planning and effective execution of clinical safety strategy. Development of effective Clinical Study documents including Clinical Safety Management plans. Meeting Global Safety Reporting requirements of Clinical Trials, Sponsor assessment of AE’s from Clinical studies, CEC and DSMB interactions, Safety data interpretation and analysis.

This position also partners with cross functional teams to ensure effective compliance to quality standards with regards to clinical safety and compliance to procedures of neurovascular product portfolio

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

A Day in the Life
Partner with cross functional teams to achieve clinical trial safety deliverables on assigned projects including:

– Contribute to CIP (Clinical Investigational Plan) ICF (Informed Consent Form), eCRF (Case Report Form), and CSR (Clinical Study Report) development
– Development of Safety Management Plans and be responsible for its training and execution
– CEC charter development and effective execution including training of CEC members
– Perform sponsor assessments of safety events and timely Potential Complaint triage.
– Meet Global Safety Reporting Requirements including Periodic Safety Reports.
– Lead Safety data cleaning of study database
– Contribute to Clinical Study Reports, Annual Progress Report’s.
– Write Safety Narratives
– Contribute to safety data trending and analysis
– Contribute to DSMB activities and other cross functional clinical safety deliverables

Must Have: Minimum Requirements
Basic Qualifications:
Bachelor’s Degree (In Scientific Discipline) with experience in Clinical Safety Accepted.
MD/RN/BSN Preferred, other medical/clinical background accepted.
2+ years of Clinical safety background
Required knowledge:
Successful track record as a safety specialist knowledgeable in medical devices
Experience in IDE/Class III product clinical trials preferred
Successful cross functional team interaction and influencing skills
Ability to be a self-starter and work independently to achieve on time deliverables.
Excellent oral and written communications;
Effective interpersonal skills with the ability to influence and lead others who may or may not be part of direct team.
Results-oriented and a strong sense of urgency
Ability to prioritize rapidly
Strong problem solving skills
Excellent decision making/analysis skills;
Ability to manage multiple projects simultaneously.
Excellent organizational skills
Knowledge of GCP, HIPPA, ISO 14155, ISO 14971, CFR 803 and Other Global Safety Reporting Requirements
Working knowledge of Clinical and Safety Database
Medical/Narrative Writing skills.
Preferred experience in minimally invasive/ endovascular product line
Experience in a global, matrix management structure.

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 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.

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.uscis.gov/e-verify/employees