Clinical Project Manager - Sunnyvale, CA | Biospace
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Clinical Project Manager

Intuitive Surgical

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Location:
Sunnyvale, CA
Posted Date:
7/31/2017
Position Type:
Full time
Job Code:
170989
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Clinical Project Manager, Clinical Research, Clinical Trial Manager,

Job Description

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

This position reports to Sr. Director of Clinical Affairs and requires a strong candidate with experience supporting evidence generation strategy and execution of clinical studies and registries. The purpose of this job function is to serve as a Clinical Project Manager to primarily develop strategies for clinical and outcomes research studies.  As a senior member of the team, this role will be responsible for developing clinical evidence strategies, designing and executing  clinical studies (both pre and post market approval phases) with minimal supervision. The candidate will be required to interpret results of clinical studies to develop a clinical study report or support the development of clinical publications.  The ideal candidate will have experience utilizing external research or registry databases to generate evidence for clinical publications or inform on clinical trial strategy.  

Requirements

Competency Requirements: (Competency is based on: education, training, skills and experience.)In order to adequately perform the responsibilities of this position the individual must:

•Previous experience supporting development of corporate publication strategy
•Significant knowledge of clinical and outcomes research study design is necessary.
•Strong  experience in conducting literature searches , reviews and appraisal of the scientific data
•Excellent ability to interact with physicians and other professionals inside and outside the company.
•Possess knowledge of Good Clinical Practice and 21 CFR Part 11 and international regulations.
•Comfortable in a hospital environment, with experience working with nurses and surgeons (5-8 years)
•Strong understanding and background of clinical trials , study design and some formal ICH/GCP knowledge and training
•Prior mentoring or supervisory experience preferred, MD, PhD or  M.S. degree in scientific field  is required
•Basic understanding of statistics, statistical methods, and design of experiment is a must
•.Must have high level of attention to detail and accuracy.
•Must be able to work effectively on cross-functional teams.
•Experience in providing work direction for others and have mentoring and interpersonal skills to manage direct reports is desired.
•Experience in clinical trials preferred (8-12 years)
•Must be able to travel up to 10-20%
•Must be able to manage multiple projects across numerous surgical disciplines
•Strong  communication, presentation  and interpersonal skills with high attention to detail and organization
•Strong experience in protocol development , writing clinical section for regulatory submission and clinical evaluation report writing
•Ability to learn quickly and self-educate on different surgical specialties  as applicable to clinical projects (Self-starter attitude)
•Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary

We are an AA/EEO/Veterans/Disabled employer.