Intuitive Surgical Careers
Senior Clinical Project (Clinical Study) Manager
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 180844
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Primary Function of Position:
This position reports to the Manager, Clinical Affairs role 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 Senior 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 as well as experience reviewing and interpreting clinical literature.
Roles and Responsibilities:
This position has responsibility and authority for:
• Responsible for monitoring 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
• Identify 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 internal stakeholders and KOLs to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives
• Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, 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
• Responsible for conducting clinical studies on schedule and within budget while ensuring high quality and compliance.
• 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 and to develop clinical strategies and clinical investigational protocols.
• Author, 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
• Provide scientific expertise to the Health Economics and Outcomes Research department for development of outcomes research analysis (including identification of appropriate diagnosis or reimbursement codes, selection of clinical outcomes for procedures of interest) preparation of manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications.
• Mentor junior clinical project manager (s) on clinical research activities.
• Assist Clinical Affairs leadership 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:
• Advanced degree in a scientific/bioengineering field (M.S., Ph. D or M.D.) or Bachelor’s degree in a scientific/bioengineering field with 8-10+ years of experience in clinical affairs/research project management is preferred• Previous experience supporting development of scientific 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.• Strong experience in protocol development , writing clinical section(s) for regulatory submission• 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• Experience implementing an pre-market/IDE trials is preferred• Basic understanding of statistics, statistical methods, and design of experiment is a requirement• Must be able to work effectively on cross-functional teams.• Must be able to travel up to 10-20%• Must be able to manage multiple projects• 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 necessary