• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies • Primary clinical point of contact with the client • Collaborate with PM on monthly invoicing and variance management of clinical budget • Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) • Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings • Generate potential site list from key stakeholders and drive site feasibility process • Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment • Develop and finalize the country recruitment/retention strategy • Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures • Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs • Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate • Support in planning and conducting investigator meetings • Review and/or approve of IP release packages • Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable • Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables • Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate • Responsible for eTMF implementation and management • Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure • Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits • Work closely with PM for project-specific resourcing issues • Escalate pertinent CRA performance and site compliance issues when necessary • Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines • Manage processes for investigational product (IP) including drug accountability and reconciliation • When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed • Support business development and marketing activities as appropriate • May negotiate site budget and investigator contract with support from the legal department and/or site contracts group • May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan • May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM • May perform clinical data review of patient profiles, data listings and summary tables, including query generation • May have line management responsibilities • Performs other duties as assigned by management

Role Description Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements. - Primary clinical point of contact with the client - Collaborate with PM on monthly invoicing and variance management of clinical budget - Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) - Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings - Generate potential site list from key stakeholders and drive site feasibility process - Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment - Develop and finalize the country recruitment/retention strategy - Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures - Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs - Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate - Support in planning and conducting investigator meetings - Review and/or approve of IP release packages - Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable - Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables - Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate - Responsible for eTMF implementation and management - Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure - Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits - Work closely with PM for project-specific resourcing issues - Escalate pertinent CRA performance and site compliance issues when necessary - Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines - Manage processes for investigational product (IP) including drug accountability and reconciliation - When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed - Support business development and marketing activities as appropriate - May negotiate site budget and investigator contract with support from the legal department and/or site contracts group - May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan - May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM - May perform clinical data review of patient profiles, data listings and summary tables, including query generation - May have line management responsibilities - Performs other duties as assigned by management Qualifications - Minimum Required: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred - Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience - Preferred: Advanced degree - Other Required: Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) - Excellent communication and interpersonal skills to effectively interface with others in a team setting - Excellent organizational skills, attention to detail, and a customer service demeanor - Ability to travel domestically and internationally including overnight stays Requirements - Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement - Working knowledge of clinical management techniques and tools - Direct work experience in a cross-functional environment - Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics - Proven experience in planning, risk management and change management - High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective - Ability to lead and inspire excellence within a team - Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency - Results oriented, accountable, motivated and flexible - Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills - Excellent presentation, verbal and written communications skills - In depth proven experience in pharmaceutical and/or device research required - Demonstrated successful independent negotiation and conflict management strategies Benefits - Compensation range: $110,700 — $200,900 USD - Discretionary annual bonus - Health insurance - Retirement savings benefits - Life insurance and disability benefits - Parental leave - Paid time off for sick leave and vacation

Title: Clinical Pharmacist Telepharmacy Location: Phoenix, Arizona, San Francisco, California, Los Angeles, California, Sacramento, California, Remote Job Description: Job Summary and Responsibilities This is a 10/hr night shift remote position Candidates must reside and be licensed in California The clinical pharmacist telepharmacy provides timely, accurate, and complete pharmaceutical care which includes performing daily pharmacist functions using standard techniques and procedures to process written and electronic medication orders issued by physicians and other qualified providers. This individual provides drug information, keeps pertinent records, oversees medication preparation and protects the well-being of patients by monitoring for adverse reactions, allergies, appropriate use and appropriate doses of ordered medications. The clinical staff telepharmacist uses clinical skills to monitor medication selection and dosage by order of the prescriber or approved medical staff protocols. The individual communicates with site staff when indicated for clarifications, dosage adjustments, lab monitoring and drug therapy recommendations. The role requires knowledge of a pharmacist scope of practice, current state requirements, other Federal or State regulatory agency requirements specific to medication order processing. Essential Key and Job Responsibilities - Reviews, verifies and interprets all physician orders received using the patient profile. Screens all medication orders for optimal medication usage and intervenes when appropriate within the standards of the clinical programs and client hospital protocols. This includes monitoring for medication allergies, drug interactions, renal and hepatic function, age-appropriate drug selection and dosage, duplicated orders, injectable compatibilities, concentrations, and administration rates. - Uses pharmacokinetic skills to determine dosing and to monitor patients' responses to selected drugs under order of the prescriber or by approved medical staff protocols in order to assure safe and consistent use of designated drugs. - Participates in continued education in pharmacy practice in order to meet regulatory requirements and organizational goals. - Supports and assists in meeting client hospital goals and specifications for order entry/verification, medication preparation and clinical programs. - Reviews, understands, and responds as appropriate in a timely manner to communication from System Director, Manager(s), and/or Supervisor(s) of Telepharmacy and from client hospital liaisons. Job Requirements Required Education and Experience - B.S. in Pharmacy or equivalent from an accredited college of pharmacy - Three years of hospital pharmacy experience as a pharmacist - Active Pharmacist license in good standing in the state of California Where You'll Work Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation's largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 137 hospital-based locations, in addition to its home-based services and virtual care offerings. CommonSpirit has more than 157,000 employees, 45,000 nurses and 25,000 physicians and advanced practice providers across 24 states and contributes more than $4.2 billion annually in charity care, community benefits and unreimbursed government programs. Together with our patients, physicians, partners, and communities, we are creating a more just, equitable, and innovative healthcare delivery system.

Ensure patient safety and care during clinical trials while managing all aspects of research protocols. Collaborate with healthcare teams to communicate patient needs and maintain compliance with regulatory standards.