• Lead or co-lead one or more complex clinical trial(s) in a therapeutic area for one or more compounds • Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP) • Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers (i.e., protocol, ICF, IB, safety updates, study reports, regulatory submissions, etc.) to support registration and commercialization of the compound(s) • Contributes in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities). • Lead the development of medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis • Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction • Prepare charters and coordinate internal/external committee meetings including presentation preparation (i.e., Dose Escalation, DMC, Steering Committee, Safety) • Participate in the development and review of study plans and serve as a liaison to project teams and CROs • Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted • Provide input for the development of publications in coordination with Scientific Communications • Perform training at Investigator meetings, CRO/CRA training, SIVs as warranted

Role Description The Senior Clinical Trial Manager (Sr. CTM) is responsible for the day-to-day management of a clinical trial or region, oversight of vendors, and clinical trial sites. This position is accountable for ensuring high quality deliverables are within timelines and budget, working closely with cross-functional teams to ensure study start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials. Work Model: Remote - Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed. Responsibilities - Responsible for the day-to-day management of assigned operational aspects, such as CRO/vendor management, drug supply management, management of clinical sites, etc. for assigned region(s) or study(s). - Manages high impact vendors, including oversight of timelines and contracts (invoicing, purchase order monitoring, and forecasting). - Oversee development and maintenance of study documents such as Study Timelines, Vendor Management Plan, Risk Management Plan, Informed Consent Form, Monitoring Oversight Plan, CRFs, Study Reference Manual, dashboards, etc. - Lead, or actively contribute to, Study Management Team meetings. - Identify study risks, develop and implement mitigation strategies. - Oversee Trial Master File, Completeness Reviews, and Essential Document List. - Support the study budgeting process, including the review of clinical trial financial accruals. - Manages direct reports. - Represents Clinical Operations on initiatives, may lead initiatives. Qualifications - Bachelor degree or equivalent is required (scientific or healthcare discipline preferred). - Typically, 8 years of direct work experience in Clinical Research, with international experience from study start up through closeout preferred. - Fully capable to independently lead all aspects of a clinical trial. - Effective leadership of cross-functional teams. - Excellent planning, organizational, and communication skills. - Able to handle multiple tasks and deadlines, and identify risks and issues and take appropriate actions. - Must be self-motivated and able to develop solutions for a variety of complex problems where analysis requires an in-depth evaluation of variable factors, including inter-organizational impact. - Must have the ability to build and maintain positive relationships with management, peers, vendors, and clinical sites. - 10% travel may be required. Benefits - Generous vacation time and public holidays observed by the company. - Volunteer days. - Long term incentive and Employee stock purchase plans or equivalent offerings. - Employee wellbeing benefits. - Fitness reimbursement. - Tuition sponsoring. - Professional development plans. - Benefits vary by region and country.

• Provide leadership and direction to clinical site management team members from study start through to closure • Serve as Site Management primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to: 1.)Primary Sponsor contact 2.)Investigator and Bid Defense Meetings 3.)Internal and External study team calls 4.)Project-specific Audits / Inspections • Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities • Oversee compliance to the Clinical Monitoring Plan, including site visits, outstanding trip reports and visit follow up letters

Title: CLS II Location: MI, Garden City Part Time ID: 2026-261866 Job Description: Overview Join an award-winning team of dedicated professionals committed to our core values of quality, compassion and community! Garden City Hospital, a member of Prime Healthcare, offers incredible opportunities to expand your horizons and be part of a community dedicated to making a difference. At Garden City Hospital, we pride ourselves on community involvement and commitment to preserving access to quality and compassionate healthcare. We are a state-of-the-art medical facility with over 300 licensed beds and a teaching hospital, offering medical education to students, residents and fellows from across the country. The residency and fellowship programs offer graduate medical education to more than 80 trainees in specialties. Garden City Hospital has an award-winning staff of over 350 of the area's best and brightest physicians from almost every specialty. Responsibilities Each individual performs only those waived, moderate, or highly complex tests authorized by CLIA, Bus. & Prof. Code Section 1204, and must possess a degree of skill commensurate with individual's education, training or experience and technical abilities. Each individual performing the above procedures must: 1) adhere to the laboratory's procedures for the collection, processing, analysis, and reporting of patient test results. 2) follow the laboratory's established quality control policies and procedures in documenting all corrective actions taken when test systems deviate from the laboratory's established performance specifications. 3) be capable of identifying problems that may adversely affect test performance and either correct the problem or immediately notify your immediate supervisor, Director, or Medical Director, 4) perform a wide variety of laboratory procedures requiring independent judgment using both manual and automated methods in Hematology, Blood Bank, Chemistry, Urinalysis, Coagulation, Microbiology, Immunology, and any other discipline as introduced into the laboratory, 5) perform and document maintenance; daily, weekly, monthly, or as needed on instruments and equipment as appropriate, 6) review the accuracy of patient results prior to releasing or reporting, 7) recognize age specific differences in expected results for newborns to geriatrics, 8) ensure that the testing of proficiency testing samples are tested in the same manner as patient samples and that collaboration with other laboratories is prohibited prior to the reporting of proficiency testing results to the appropriate agencies, 9) may be required to perform venipuncture or capillary puncture on various age groups from newborn to geriatrics, 10) assist in the development and maintenance of laboratory policies and procedures, 11) adheres to all department and hospital policies and procedures related to safety, infection control, emergency preparedness, and human resources, 12) in the absence of a supervisor, may be assigned/identified as Lead Tech, having responsibility for the section or department during their shift, 13) may be assigned responsibilities related to LIS and/or POC. 14) other tasks or responsibilities may be assigned by the department manager/director. Qualifications Education and Work Experience 1. ASCP certification, or equivalent preferred. 2. Minimum two years of hospital laboratory work experience required. 3. Bachelor&rsquo;s Degree in chemical, physical, biological health science or Medical Laboratory Technology from an accredited institution, or other educational requirements stated in CLIA (42 CFR 493.1423). 4. Current and Valid State License if the laboratory is located in a state where required. Employment Status Part Time < 60 Shift Days Equal Employment Opportunity Company is an equal employment opportunity employer. Company prohibits discrimination against any applicant or employee based on race, color, sex, sexual orientation, gender identity, religion, national origin, age (subject to applicable law), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws.