Senior Clinical Study Manager

Intuitive•Sunnyvale, CA

About The Position

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.

Requirements

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
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.

Nice To Haves

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

Responsibilities

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).