• support late-phase clinical development by contributing to protocol development, study start-up, data review and monitoring and analysis activities • Working collaboratively with the study team and clinical leadership • focus on study-level implementation and cross-functional coordination to help ensure high-quality, decision-ready clinical data • Support set up and execution of late phase clinical trials with a focus on data quality • Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity • Provide input into and implementation of data management plan, CRF design, and data review oversight • Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission • Assists Development Lead and Clinical Scientist Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects • Anticipate and actively manage problems across a broad spectrum of cross-functional teams • Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents • Support appropriate training, recruitment, and development requirements for matrix team resources.

• Serve as a primary science lead on clinical trials supported by Cogstate, with a focus on cognitive testing and associated services. • Liaise with sponsor contacts to address scientific questions, with a focus on empirical and objective data. • Review clinical trial protocols and advise on (and develop specifications for) the configuration of Cogstate software to match study designs and scientific objectives. • Understand and advise on cognitive outcome measures and cognitive tests. • Participate in study methodology and new clinical trial software design. • Interact with project management, statistics, data management, programming, and site services teams internally to support scientific processes and studies. • Develop solutions to unique customer requests relating to topics such as stratification, inclusion, reliable change monitoring, data monitoring, normative data, and other cognitive testing applications. • Review and monitor cognitive data for completion and performance. • Analyze and interpret cognitive data from clinical trials and research studies. • Write clinical study reports, statistical reports, central monitoring reports, white papers, and other analytic reports. • Critically evaluate internal processes and scientific methodologies. • Contribute to the development of processes, technology, and infrastructure which support the functions of scientific services and related operations. • Oversee and provide higher-level support for device qualification and configuration activities to ensure adequate timing properties for Cogstate computerized tests. • Oversight and implementation of data monitoring and rater training services. • Develop rater training materials.

We are so glad you are interested in joining Sutter Health! Organization: PAMF-Palo Alto Medical Foundation PAD Position Overview: **This position is eligible to work from home but must be available to go on-site as needed** Oversees and delivers pharmaceutical care through the provision of patient-centered clinical service, medication information, education, medication preparation and distribution that ensures safe, effective, and cost efficient medication therapy. Exercises sound judgment, and developed clinical skills to provide input to and implement the patient's plan of care based on the diagnosis in a timely manner. Gains confidence and cooperation from the patient, their family/support group, and other healthcare providers through competent patient assessment, attentive monitoring and care, and effective communication. Adheres to all local/state/federal regulations, codes, policies and procedures to ensure privacy and safety while delivering optimal patient care. May also be responsible for performing specific procedures and/or teaching duties. Uses professional judgment and clinical expertise in the daily solving of complex problems. Job Description: EDUCATION - PHARMD-Graduate of an accredited pharmacy school CERTIFICATION & LICENSURE - PHARMR-Current registration or Registered Pharmacist within 120 days TYPICAL EXPERIENCE: - 3 years recent relevant experience. SKILLS AND KNOWLEDGE: - Knowledge of medical terminology, generic and trade pharmaceutical names, pharmaceutical calculations and laws and regulations. - Knowledge and understanding of different Pharmacy practice settings, including narcotic delivery and procedures. - Knowledge and ability to identify and employ pharmaceutical and medical terms, abbreviations and symbols commonly used in prescribing, dispensing, and record keeping of medications. - Requires a basic working knowledge of legal requirements and accreditation standards including The Joint Commission, Title XXII, Department of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), and United States Pharmacopeia (USP). - Possess written and verbal communications skills to explain sensitive information clearly and professionally to diverse audiences, including non-medical people. - General knowledge of computer applications, such as Microsoft Office Suite (Word, Excel and Outlook), related pharmaceutical technology, Electronic Health Records (EHR), and EPIC. Job Shift: Days Schedule: Full Time Shift Hours: 8 Days of the Week: Monday - Friday Weekend Requirements: None Benefits: Yes Unions: No Position Status: Non-Exempt Weekly Hours: 40 Employee Status: Regular Sutter Health is an equal opportunity employer EOE/M/F/Disability/Veterans. Pay Range is $98.34 to $113.09 / hour The compensation range may vary based on the geographic location where the position is filled. Total compensation considers multiple factors, including, but not limited to a candidate’s experience, education, skills, licensure, certifications, departmental equity, training, and organizational needs. Base pay is only one component of Sutter Health’s comprehensive total rewards program. Eligible positions also include a comprehensive benefits package.

• Provide statistical leadership across one or more clinical programs • Lead the development and review of statistical deliverables, including protocols and regulatory submission materials • Serve as a key statistical representative in cross-functional team discussions • Ensure statistical approaches comply with regulatory standards and industry best practices • Review and interpret analysis outputs for accuracy and regulatory compliance • Collaborate with cross-functional teams • Communicate statistical concepts clearly to stakeholders