Senior Clinical Study Manager

Intuitive•Sunnyvale, CA

17d

About The Position

Primary Function of the Position This position requires a candidate with extensive experience supporting evidence generation strategy and execution of clinical studies. The Senior (Clinical Study Manager 4) role will develop and execute strategies for clinical and outcomes research studies to support regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, this role will be responsible for working with key stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision. 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 support 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 multi-center, premarket studies in the United States (IDE for 510k or PMA submissions) and utilizing resources to research and scope research topics and to provide recommendations on clinical trial strategy. The candidate is also expected to have experience reviewing, interpreting and summarizing clinical literature.

Requirements

Previous experience implementing, supporting and managing medical device trials
Significant knowledge of clinical and/or outcomes research study design
Strong experience in protocol and ICF development, writing clinical section(s) for regulatory submission
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
Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental understanding 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 depending on business requirements
Must be able to manage multiple projects and/or balance competing priorities
Strong communication, presentation and interpersonal skills with high attention to detail and organization
Ability to learn quickly, adapt to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects (“Self-starter attitude”)
Ability to lead project team consisting of CRAs and CTAs and support management with relevant study updates
Exhibits strong work ethic to help meet aggressive timelines or multiple projects when necessary with a problem-solving mindset
Minimum Advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in clinical research, or Bachelor’s degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research is preferred, or a minimum of 10 years of experience in clinical research with relevant training

Nice To Haves

Comfortable in a hospital environment, experience working with nurses and surgeons preferred
Understanding of statistics, statistical methods, and design of experiment is strongly preferred
Extensive experience with close and independent management of pre-market clinical studies (First Human Use or IDE) used for regulatory submissions
Strong track record of KOL management for multi-center studies
Experience working on global or multi-national studies

Responsibilities

Responsible for leading assigned clinical research activities
Collaborate with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiatives
Responsible for the planning and execution of the clinical studies including site selection, analysis 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
Responsible for independently conducting clinical studies on schedule and within budget while ensuring high quality and compliance
Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits.
Conduct clinical study monitoring 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 support in internal audit/inspection and ensure sponsor audit readiness
Liaise with external vendors and sites to negotiate contracts and budgets in collaboration 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 support development of scientific publications
Track, process and manage site payments and support in study financial tracking by developing tracking tools as necessary
Organize and lead 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 determine 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, collaborate with commercial groups (i.e., marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities
For post-market research, 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)
Work with clinical investigators to prepare manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications in collaboration with management
Support regulatory submission and approval of pre-market clinical studies and 510k(s), responsible for addressing regulatory body questions on clinical study design and results (e.g., protocol, ICF, eCRF, clinical study reports).