Intuitive Surgical Careers
Associate Clinical Project (Clinical Study) Manager
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 181062
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Primary Function of Position:
This position reports to Manager, Clinical Affairs and requires a strong candidate looking to develop experience supporting evidence generation strategy and execution of clinical studies and registries. A candidate must have some previous experience around understanding clincal literature, clincal research and/or clinical affairs The purpose of this job function is to serve as an Associate Clinical Project Manager to support the development of strategies for clinical and outcomes research studies. This role is intended to provide a candidate with an opportunity to further develop knowledge and experience in developing clinical evidence strategies, designing and executing clinical studies (both pre and post market approval phases) with guidance and some instruction from current team members. The candidate will be required to review and summarize clinical literature for multiple purposes, including the development of clinical trial strategy, as well as working with internal stakeholders on setting up clinical trials or clinical data collection studies and potentially supporting the development of Clinical Evaluation Reports. The ideal candidate will have experience utilizing external research or registry databases to generate evidence for clinical publications or inform on clinical trial strategy.
Roles and Responsibilities:
This position has responsibility and authority for:
- Understanding publication landscape to stay abreast of scientific knowledge and market trends through regular review of scientific literature in order to help develop clinical evidence strategies
- Supporting the identification of evidence gaps or market opportunities to design and execute clinical trials and outcomes research evidence studies with minimal supervision
- Contribute to the development and implementation of clinical research strategies to meet business goals and objectives.
- Collaborate with clincal project managers and internal stakeholders to develop and review study concepts, protocol and study outlines
- Responsible for supporting the execution of the clinical studies including investigator selection, analysis of potential patient recruitment, supporting the creation of study related documents (protocols, case report forms, Informed consents, Clinical trial agreements), organizing IRB/EC submissions with follow thorough to ensure successful outcome
- Participate in data analysis, interpretation and synthesis, instruction in order to develop Clinical study report and /or support development of scientific publications.
- Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
- Conduct literature searches, critically appraise scientific literature and write clinical summaries for, products and surgical procedures to assist research and development efforts, to develop Clinical Evaluation Reports, and to develop clinical strategies and clinical investigational protocols.
- Review and revise Clinical Operations Standard Operating Procedures (SOPs).
- Collaborate with commercial groups (i.e. marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities
- Assist Clinical Affairs Manager/Director for building departmental process improvement initiatives.
Competency Requirements: (Competency is based on: education, training, skills and experience.)In order to adequately perform the responsibilities of this position the individual must have:
- Previous experience in industry (medical device, biotechnology, or diagnostics) and experience supporting development of corporate publication strategy
- Exposure to clinical and outcomes research study design is necessary.
- Experience in conducting literature searches, reviews and appraisal of the scientific data is preferred
- 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
- Posses some understanding and background of clinical trials, study design and some formal ICH/GCP knowledge and training
- Basic understanding of statistics, statistical methods, and design of experiment is a preferred
- 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. (2-5 years preferred)
- Must be able to travel up to 10-20%
- Must be able to manage or support multiple projects across numerous surgical disciplines
- Strong communication, presentation and interpersonal skills with high attention to detail and organization
- experience in protocol development , writing clinical section for regulatory submission and clinical evaluation report writing is preferred
- 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
- B.S. in a scientific field, with an advanced degree preferred & 5 years or equivalent relative experience
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.