Remote Senior Clinical Trial Manager ID 2013

Note: The job is a remote job and is open to candidates in USA. Ascendis Pharma is a fast-growing global biopharmaceutical company developing therapies in endocrinology, rare disease, and oncology through its TransCon drug development platform. The Senior Clinical Trial Manager will lead and support the effective conduct of global and regional clinical trials, coordinating cross-functional teams, clinical sites, vendors, regulatory activities, data quality, and trial documentation. The role is based in Palo Alto, California, or may be remote, and reports to the Director of Clinical Operations.ResponsibilitiesFoster and maintain favorable clinical site and investigator relationships. Including conducting and/or supporting informational calls for sites and investigatorsSupport in planning and conducting investigator meetings, if applicableReview and/or approve of IP release packagesReview monitoring reports for compliance to study protocols, regulations and ICH/GCP. Track and manage monitoring report metrics. If applicable, serve as a backup monitor to the monitoring teamGenerate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plans and communicates issues to Director and CRAs as appropriateEnsure accurate reporting of Protocol Deviations and follows up with monitoring team of any subsequent re-SDV and close out of PDs if applicableProvides any assistance with findings from Protocol Deviation Review Team meetings and disseminates any applicable information to the CRA teamConducts monitoring meetings, creating agendas and meeting minutes which may include but is not limited to: monitoring team training and tracking, report quality issues, site level issues/trends in data and EDC metrics reportingAssist in coordinating study specific training or re-training for the internal study team, internal monitoring team and site staff as appropriateResponsible for the ongoing development and maintenance of Trial Master File and Investigator Site Files in Veeva Vault which includes quarterly eTMF reviews. Assists CRAs in ensuring eTMF completeness, eTMF audit findings and resolutionsManages and/or supports vendor management for central laboratory, central IRB, central imaging, patient concierge services, and site payment systems including but not limited to: portal access management for sites and internal teams, report review, sample tracking, metrics review, document reviews and meeting participationFacilitate EDC and IRT access requests for site teamsFacilitate CRA team access to internal Ascendis systems such as TMF, EDC and vendor systems (e.g. IRT)Assist and manage CRA transition meetings which may include creating and/or reviewing transition documentationRun Study Team Meetings including providing agendas and meeting minutesReviews site information/informed consents and completes associated checklists as per Ascendis SOPsSupport central and site IRB/IEC and regulatory submissions, as neededAccountable to assist sites, internal staff and CRAs with the preparation for GCP auditsMaintains CTMS including but not limited to: site and site staff contact information, study level and site level milestones, regulatory submissions and approvals on both study and site levelEscalate pertinent CRA performance and site compliance issues when necessaryCollaborate with Director of Clinical Operations, data management and CRAs to ensure data quality and compliance with data cleaning timelinesAssist CRAs and sites with supply shipment/tracking, sample tracking and IMP shipment tracking and managementMay review and approve Vendor Data Clarification FormsPrioritize and escalate issues, as neededMay develop or assist in developing 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)May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with Associate DirectorMay be responsible for development, review and/or implementation of vendor documentationMay perform clinical data review of patient profiles, data listings and summary tables, including query generationMay meet with Associate Director, Clinical Operations on a regular basis to report deliverables, timelines and employee developmentSkillsBachelor's degree or master's degree in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent) preferred, or equivalent work experienceDemonstrates mastery knowledge of ICH-GCP, relevant Ascendis SOPs and Work Instructions and regulatory guidance, as well as the ability to implementWorking knowledge of clinical management techniques and toolsDirect work experience in a cross-functional environment7+ years of combined experience in managing/monitoring Phase 1, 2, or 3 clinical trialsHigh proficiency in English with .