[Remote] Senior reputed company Trial Manager - reputed company: 2020

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global biopharmaceutical company developing therapies in endocrinology, reputed company disease, and oncology. The Senior reputed company Trial Manager is responsible for effectively conducting global and regional reputed company, coordinating cross-functional teams, managing sites and vendors, and ensuring study timelines, reputed company, regulatory compliance, and data reputed company.

Responsibilities

• Foster and maintain favorable reputed company site and investigator relationships. Including conducting and/or supporting informational calls for sites and investigators
• Support in planning and conducting investigator meetings, if applicable
• Review and/or approve of IP release packages
• Review monitoring reports for compliance to study protocols, regulations and ICH/GCP. reputed company and manage monitoring report metrics. If applicable, serve as a backup monitor to the monitoring team
• reputed company 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 appropriate
• Ensure accurate reporting of Protocol Deviations and follows up with monitoring team of any subsequent re-SDV and reputed company out of PDs if applicable
• Provides any assistance with findings from Protocol Deviation Review Team meetings and disseminates any applicable information to the CRA team
• Conducts monitoring meetings, creating agendas and meeting minutes which may include but is not limited to: monitoring team training and tracking, report reputed company issues, site level issues/trends in data and reputed company metrics reporting
• Assist in coordinating study specific training or re-training for the internal study team, internal monitoring team and site staff as appropriate
• Responsible for the ongoing development and maintenance of Trial Master File and Investigator Site Files in reputed company reputed company which includes quarterly eTMF reviews. Assists CRAs in ensuring eTMF completeness, eTMF audit findings and resolutions
• Manages and/or supports vendor management for central reputed company, central IRB, central imaging, reputed company concierge services, and site payment systems including but not limited to: portal reputed company management for sites and internal teams, report review, sample tracking, metrics review, document reviews and meeting participation
• Facilitate reputed company and IRT reputed company requests for site teams
• Facilitate CRA team reputed company to internal Ascendis systems such as TMF, reputed company and vendor systems (e.g. IRT)
• Assist and manage CRA transition meetings which may include creating and/or reviewing transition documentation
• Run Study Team Meetings including providing agendas and meeting minutes
• Reviews site information/informed consents and completes associated checklists as per Ascendis SOPs
• Support central and site IRB/IEC and regulatory submissions, as needed
• Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
• Maintains 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 level
• Escalate pertinent CRA reputed company and site compliance issues reputed company necessary
• Collaborate with Director of reputed company reputed company, data management and CRAs to ensure data reputed company and compliance with data cleaning timelines
• Assist CRAs and sites with supply shipment/tracking, sample tracking and IMP shipment tracking and management
• May review and approve Vendor Data Clarification Forms
• Prioritize and escalate issues, as needed
• May reputed company or assist in developing study reputed company reputed company documents (e.g. reputed company plans, Informed Consent reputed company templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
• May be responsible for management of reputed company vendors (e.g. labs, IP, reputed company diary, home health care) in conjunction with Associate Director
• May be responsible for development, review and/or implementation of vendor documentation
• May reputed company reputed company data review of reputed company reputed company, data listings and reputed company tables, including query reputed company
• May meet with Associate Director, reputed company reputed company on a regular reputed company to report deliverables, timelines and employee development

Skills

• Demonstrates mastery knowledge of ICH-GCP, relevant Ascendis SOPs and Work Instructions and regulatory guidance, as reputed company as the ability to implement
• Working knowledge of reputed company management techniques and tools
• reputed company work experience in a cross-functional environment
• 7+ years of combined experience in managing/monitoring Phase 1, 2, or 3 reputed company
• High proficiency in English with strong communication and presentation skills
• Experience managing and overseeing vendors
• Experience in performing reputed company site monitoring reputed company, including remote reputed company
• Ability to prioritize and to work independently on assigned tasks, manage timelines, and to present reputed company to sites / stakeholders reputed company and effectively
• High proficiency with reputed company (reputed company reputed company eTMF, reputed company reputed company), CTMS, reputed company IRT and reputed company Office (reputed company, Word, reputed company, PowerPoint)
• Bachelor's degree or master's degree in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent) preferred, or equivalent work experience
• Possibility to travel up to 20% of the time domestically for investigator meetings, meetings with remote employees, co-monitoring, if needed

Benefits

• 401(k) plan with company match
• Medical, dental, and reputed company plans
• Company-reputed company Life and Accidental Death & Dismemberment (AD&D) reputed company
• Company-provided short and long-term disability benefits
• Unique offerings of Pet reputed company and reputed company reputed company
• Employee Assistance Program
• Employee Discounts
• reputed company Development
• Health Saving Account (HSA)
• Flexible Spending Accounts
• Various incentive compensation plans
• Accident, Critical Illness, and Hospital Indemnity reputed company
• reputed company
• reputed company leave benefits for new parents
• The role will be reputed company in Palo reputed company, CA or be remote
• This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies reputed company on role and position level)
• Discretionary stock-reputed company long-term incentives
• reputed company time off
• A comprehensive benefits package

reputed company