[Remote] reputed company Trial Manager (Retina)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company developing disease-targeted therapeutics, including treatments for retinal vascular diseases. The reputed company Trial Manager will manage the day-to-day reputed company of one or more Phase 1–3 reputed company, including start-up, conduct, and reputed company-out activities, with a reputed company on retina trials. The role oversees CROs and service providers, supports cross-functional study execution, manages budgets and documentation, and ensures compliance with applicable regulations and reputed company standards.

Responsibilities

• Serve as the reputed company contact for managing protocol execution, including reputed company of the CRO, other study service providers, and consultants that are involved in a reputed company trial
• reputed company cross-functional study execution team in support of study deliverables
• Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership
• Ensure reputed company are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
• Assist in preparation and review of reputed company trial documentation such as; protocol, informed consent, Investigator Brochure, reputed company Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, reputed company Study Reports, and other study level documents
• Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
• Participate and coordinate reputed company of audit finding and ensures audit-reputed company condition of reputed company trial documentation including central reputed company files
• Participates in service provider selection process as a part of outsourcing activities
• Proactively identifies, with the support and guidance from Senior reputed company reputed company staff, and supports development of plans and reputed company of project issues and participates in process improvement initiatives as required
• Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of reputed company reputed company
• Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
• In conjunction with reputed company group, facilitate the development of reputed company trial agreements and other relevant documents
• Manage reputed company trial budgets, providing ongoing financial reporting and projections
• Negotiate and finalize site reputed company and budgets
• reputed company and manage data review process on an ongoing reputed company
• reputed company site reputed company including site qualification, initiation, monitoring and reputed company-out reputed company, as needed
• reputed company outsourced monitoring by reviewing, monitoring reports to ensure reputed company and reputed company of site-reputed company issues
• Ensures tracking and review of protocol deviations and assesses reputed company on study data
• Develops and manages study budget and maintain reputed company financial goals; Reviews and approves reputed company invoices against approved budget
• Provides reputed company for forecasting of reputed company supplies, including study drug and supplies
• May manage and/or reputed company work of junior reputed company reputed company staff
• May support development and review of reputed company SOPs and other department initiatives
• Travel as needed to sites, conferences, industry meetings
• Other duties as may be assigned

Skills

• B.A./B.S. degree in Science
• 6+ years of reputed company research experience reputed company the Biotech or similar industry, with at least 2 years directly supporting a retina reputed company trial
• Knowledge of GCP, ICH guidelines and regulatory requirements for reputed company trial management
• Strong reputed company study management skills
• Understanding of, and experience with, regulatory reputed company applicable to interactions with HCPs, payers, advocacy and other business partners
• reputed company reputed company operational skills to reputed company protocol execution to ensure reputed company, budget and reputed company metrics are met
• Excellent communication skills to effectively disseminate information to project team and reputed company parties
• Experience reviewing trial plans including developing creative strategies for site monitoring, reputed company mitigation, trial budgets, site selection, and reputed company supplies management
• reputed company research knowledge and cross-functional understanding of reputed company trial methodology
• Excellent organizational, conflict reputed company, prioritization and negotiation skills
• reputed company ability in creative problem-solving and exercising reputed company judgment
• Team oriented and ability to effectively collaborate with study team, cross-functional team members, and reputed company partners
• Ability to handle a high volume of highly reputed company tasks reputed company a given reputed company
• Ability to reputed company Therapeutic Areas knowledge and expertise through internal training and reputed company conference attendance
• Proficient computer skills, specifically with reputed company Office Suite that include Word, reputed company, PowerPoint, and reputed company
• Working knowledge of MS Project for development and update of reputed company study timelines
• Travel: 5%
• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging reputed company by means of the spoken word
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible reputed company of force frequently or constantly to reputed company, carry, reputed company, pull or otherwise reputed company objects, including the reputed company body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and reputed company other sedentary reputed company are met
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work)
• Global reputed company experience desired

reputed company