Senior Clinical Research Specialist - Santa Rosa , CA | Biospace
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Senior Clinical Research Specialist

Medtronic

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Location:
Santa Rosa , CA
Posted Date:
8/25/2017
Position Type:
Full time
Job Code:
140830
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

MAIN PURPOSE OF JOB
The Senior Clinical Research Specialist will collaborate with Clinical leadership to define the global clinical evidence development strategy for a newly launched medical device and support other clinical activities related to clinical study design planning and execution, literature reviews, External Research Program management, and other key sustaining activities. This position will be responsible for managing and meeting the objectives of a clinical study or clinical program and will play a key role in the fast-growing endoVenous business at Medtronic.

Requisition 17000F4A
https://medtronic.taleo.net/enterprise/enterprise/flex.jsf?lang=en#bhmPID=requisitionFile;bhmDID=1066520;requisitionKey=596142;hireTypeKey=1;isNewReq=false

Requirements

MAIN JOB DUTIES/RESPONSIBILITIES  
Performs the following tasks with general direction:
•   Designs, plans, and implements clinical studies consistent with global clinical evidence strategy
•   Determines study objective, strategy, scope and schedule in order to meet business needs
•   Develops and maintains a high level of medical, technical and clinical expertise through relevant literature, scientific meetings, and interaction with various inside/outside experts
•   Collaborates closely with key opinion leaders
•   Partners with cross-functional project teams, e.g. R&D, Regulatory Affairs, Marketing and Sales
•   Develops the Clinical Investigational Plan and supporting documents in consultation with the cross-functional project teams, investigators and the clinical team as appropriate for a clinical project
•   Reviews and approves required documents for study start, assures continued validity of such documents, takes actions for updates and/or replacements, and monitors site activation
•   Coordinates activities of associates (assigned clinical staff) and investigators to ensure compliance with CIP and overall clinical objectives
•   Participates in the selection of and manages CRO activities
•   Performs site visits to supervise and coordinate clinical studies
•   Evaluates clinical data/information, provides interim and final reports, convenes and directs investigator conferences to review findings and advise on direction
•   Serves as a medical / scientific consultant to marketing or research project teams and governmental regulatory agencies
•   Develops and manages budgets for assigned clinical studies and / or clinical research projects
•   Reports on progress and results of clinical investigations
•   Interprets, evaluates and analyzes clinical data, provides interim / final reports

IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
BASIC QUALIFICATIONS:
•   Bachelors degree. Masters degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience.
•   4+ years experience directly supporting clinical research or similar experience in a medical/scientific area.

COMPETENCIES
•   Global perspective
•   Customer focus
•   Demonstrated ability to work effectively on cross-functional and international teams
•   Effective communication (advanced written and oral communications skills)
•   Able to manage multiple tasks
•   Results and quality oriented
•   Technical writing
•   Proficient knowledge of medical terminology
•   Expertise with GCPs and regulatory compliance guidelines for clinical trials
•   Good understanding of biostatistics and trial design


MEDTRONIC OVERVIEW:
Together, we can change healthcare worldwide.  At Medtronic, we push the limits of what technology 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 can 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.

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
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.