Job Description

Primary Function of the Position

This position requires a candidate with extensive experience with planning, study start-up, and execution of clinical studies. This Lead Clinical Study Manager-4 (CSM IV) / Senior Clinical Study Manager role will develop and execute strategies for US and global first-human-use and pivotal pre-market clinical trials to help regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, this role will be accountable for working with key stakeholders to design and develop clinical protocols and other key study documents, effectively interact with key opinion leaders (KOLs) and execute clinical studies (pre-market or post-market studies), independently and with minimal supervision. This position may also serve as a mentor for other clinical study managers in the department. The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, develop clinical study reports, or help the development of clinical publications. During trial execution, the CSM will drive the progress of the trial during site selection, site start-up and through enrollment and follow-up. The CSM will clearly provide guidance to the monitors about monitoring needs, and oversee compliance work on the study. The CSM will also take a leadership role in external communication with investigators and study teams. The ideal candidate will have experience previously managing premarket studies in the United States and/or experience with multi-national studies and scoping research topics to provide recommendations on clinical trial strategy. The candidate is also expected to have experience identifying, reviewing, interpreting and summarizing clinical literature.

Essential Job Duties

• Accountable for leading assigned clinical research activities
• Partner with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiatives
• Accountable for the planning and execution of the clinical studies including site selection, review of potential patient recruitment and projections, creation of study related documents (protocols, case report forms, Informed consents, Clinical trial agreements, study reports), organizing IRB/EC submissions with follow-thorough to ensure successful progress
• Accountable for autonomously conducting clinical studies on schedule and within budget while ensuring high quality and compliance
• Oversee 3rd parties and/or clinical research organizations (CROs), as applicable
• Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits.
• Conduct clinical study monitoring and/or oversee CRAs to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring plan
• Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites or in data listings to ensure regulatory and protocol compliance and overall accuracy
• Liaise with sites and help in internal audit/inspection and ensure sponsor audit readiness
• Liaise with external vendors and sites to negotiate contracts and budgets in partnership with the legal team and management
• Track study progress and provide regular status reports
• Work closely with Biostatisticians on data analysis, interpretation and synthesis, in order to develop clinical study reports and /or help development of scientific publications
• Track, process and manage site payments and help in study financial tracking by developing tracking tools as necessary
• Organize and drive study meetings and other study activities as assigned
• Mentor junior clinical study manager(s); provide guidance to CRAs and CTAs on monitoring and other study needs
• Follow corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines) and proactively manage studies, following such guidelines and requirements
• Conduct literature searches and familiarize with literature to stay informed and abreast of relevant scientific/clinical knowledge and/or to establish evidence gaps
• Critically appraise scientific literature and write clinical summaries to assist research and the 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
• For post-market research, partner with commercial groups (i.e., marketing) to know about market trends and utilize information to help of business goals through Clinical Affairs activities
• Drive cross-functional alignment with teams including but not limited to: Medical Officers, Medical Affairs, Clinical Research/Development Engineering, Regulatory and Market Acess
• For post-market research, provide scientific expertise to the Health Economics and Outcomes Research department for development of outcomes research review (including identification of appropriate diagnosis or reimbursement codes, selection of clinical outcomes for procedures of interest)
• Work with clinical investigators to prepare manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications in partnership with management
• Help regulatory submission and approval of pre-market clinical studies and 510k(s), accountable for addressing regulatory body questions on clinical study design and results (e.g., protocol, ICF, eCRF, clinical study reports).

Qualifications

Required Skills and Experience

• Previous experience managing and implementing pre-market medical device trials. Significant knowledge of clinical and/or outcomes research study design
• Proven experience in protocol and ICF development, writing clinical section(s) for regulatory submission
• Proven 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
• Knowledge of Good Clinical Practice ICH/GCP, FDA regulations, and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
• Experience negotiating clinical research contracts and budgets
• Must be able to work effectively on cross-functional teams
• Must be able to travel 25-40% or based on business requirements
• Must be able to manage multiple projects and/or manage different priorities
• Proven communication, presentation and relational skills with high attention to detail and organization
• Ability to learn quickly, tailor to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects ("Self-starter attitude")
• Ability to drive project team consisting of CRAs and CTAs and support management with relevant study updates
• Exhibits solid work ethic to help meet tight timelines or multiple projects when necessary with a problem-solving mindset

Required Education and Training

• Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in industry sponsored clinical research, or Bachelor's degree in a scientific/bioengineering field with a minimum of 8 years of experience in industry sponsored clinical research is preferred, or a minimum of 10 years of experience in industry sponsored clinical research with relevant training.

Preferred Skills and Experience

• Accustomed to working in a hospital environment, experience working with nurses and physicians preferred
• Knowledge of statistics, statistical methods, and design of experiment is highly preferred

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.