Clinical Study Manager

Job Description

Job: Clinical Affairs
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 193758
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.
Primary Function of Position:
This position reports to Manager II, Clinical Affairs and requires a strong candidate with experience supporting evidence generation strategy and execution of clinical studies and registries. A candidate must have previous experience around understanding clinical literature, clinical research and/or clinical affairs The Sr. Clinical Study Manager will develop strategies for clinical and outcomes research studies. As a senior member of the team, this role will be responsible for working with key stakeholders to design and develop clinical protocols, and execute clinical studies (pre and/or post market) with minimal supervision. The candidate will be required to work closely with data management and biostatistics to review and interpret results of clinical studies and to develop a clinical study report or support the development of clinical publications. The ideal candidate will have experience previously managing clinical studies in the United States or Europe and can resources to research and scope a research topic and to provide recommendations on clinical trial strategy. The candidate is also expected to have experience in reviewing, interpreting and summarizing clinical literature.
Roles and Responsibilities:
This position has responsibility and authority for:
• Responsible for leading pre and post-market clinical research activities in medical devices, with a focus on post-market evidence generation studies• Collaborate with internal stakeholders and KOLs (key opinion leaders) to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives • Conduct literature searches to stay abreast of scientific knowledge and to determine the evidence gaps for current and future study needs as well as shape overall program• Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, creation of study related documents (including protocols, case report forms, Informed consents, Clinical trial agreements), organizing IRB/EC submissions with follow thorough to ensure successful outcome • Responsible for independently conducting clinical studies on schedule and within budget while ensuring high quality and compliance • Liaise with external vendors and sites to negotiate contracts and budgets • Participate in data analysis, interpretation and synthesis with biostatistician support, in order to develop Clinical study reports and /or support development of scientific publications including peer-reviewed manuscripts in partnership with external key opinion leaders• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines) • Critically appraise scientific literature and write clinical summaries to assist research efforts and development of clinical strategies and clinical investigational protocols. • Review and revise Clinical Operations Standard Operating Procedures (SOPs) to assist Clinical Affairs Leadership with continuous process improvement initiatives. • Collaborate with commercial groups (i.e. marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities • Develop strong relationships with key opinion leaders in both academic and community based settingsQualifications
Skill/Job 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 have: • Advanced degree in a scientific/bioengineering field (M.S., Ph. D or M.D.) or Bachelor’s degree in a scientific/bioengineering field with 7+years of experience in medical device clinical affairs/research study management is-required• Previous experience in implementing, supporting and managing pre and/or post-market industry sponsored device trials, including the detailed review of study data and/or monitoring• Knowledge of clinical and outcomes research study design is necessary. • Knowledge of the pulmonary space or anatomy, and/or lung cancer is preferred• Experience in conducting literature searches, reviews and appraisal of the scientific data is preferred• Experience in protocol development and/or writing clinical section for regulatory submission for studies or submissions intended for commercially available products • Ability to interact with physicians in academic and community settings and other professionals inside and outside the company, including commercial representatives within the organization • Possess knowledge of Good Clinical Practice ICH/GCP, 21 CFR Part 11 and international regulations. • Comfortable in a hospital environment, with experience working with nurses and surgeons • 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. • Must be able to travel up to 20% • Must be able to manage or support multiple projects or studies• Strong communication, presentation and interpersonal skills with high attention to detail and organization • 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 necessaryWe 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.