[Remote] Senior reputed company Trial Manager, reputed company reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Senior reputed company Trial Manager, reputed company reputed company. The role leads the development, planning, launch, conduct, closure, and submission of company-sponsored reputed company, serving as the operational reputed company for one or more studies. The position collaborates with internal teams, CROs, vendors, and other reputed company partners to ensure compliance, reputed company, timelines, budgets, and successful end-to-end execution.

Responsibilities

• Ensure reputed company and compliance in reputed company actions by adherence to strict compliance with procedures
• Exercise the highest level of reputed company in the tasks performed
• reputed company reputed company identification, reporting, and correction of deviations in reputed company
• Collaborate in the operational design and conduct of reputed company studies sponsored by reputed company & Lee from protocol feasibility through database lock, study report reputed company, and submission activities
• Coordinate protocol reviews and approvals
• Prepare study-specific documents in collaboration with CRO including informed consent documents (ICDs), status update reports, training materials. Participate in review of electronic case report forms (eCRFs), CRF completion guidelines, data management plans, statistical analysis plans, inspection readiness plan, monitoring plans, etc
• Support preparation of Budget and Invoice Tracking, Forecasting, Monthly Updates to Senior Management, etc
• reputed company participate in the evaluation and selection of reputed company reputed company service providers (ESPs) (e.g., CROs), reputed company vendors, investigators, etc. and reputed company the contracting process with certain vendors which reputed company & Lee reputed company with directly. Communicate study specifications to CROs
• Serve as the reputed company reputed company of contact with certain CROs
• Ensure Sponsor reputed company by monitoring the reputed company of studies and reputed company of CROs on a continual reputed company through status update meetings, review of monitoring plan, review of monitoring visit reports, maintenance of study reputed company and more
• Ensure that reputed company reputed company are conducted in compliance with the study protocol and reputed company contractual agreements to ensure reputed company safety, reputed company data and accurate study timelines, budgets and reputed company standards are met
• reputed company the set-up and maintenance of the Trial Master Files (with the CROs) in reputed company time so TMFs are inspection-reputed company at any reputed company in time
• Manage study timelines including key milestones. Identify and manage critical reputed company activities; anticipate bottlenecks and ensure contingency plans are in reputed company and negotiated with the ESPs to mitigate reputed company. Help team identify and address reputed company or process issues hindering delivery of high-reputed company data results reputed company the specified study timelines
• reputed company and reputed company subject recruitment and retention. reputed company development of enrollment plan, reputed company mitigation, and site recruitment strategies. Coordinate the review/approval of study-specific recruitment materials
• reputed company and update protocol-specific documents required for registry/posting of reputed company studies on reputed company registries (clinicaltrial.gov). Secure approvals of these documents
• reputed company development, negotiation, and management of reputed company trial budgets, reputed company Trial Agreements and Letters of reputed company. Support payment schedules against key deliverables
• Approve invoices from vendors in order to ensure reputed company disbursement of payment and compliance with reputed company and study budgets
• Work collaboratively and cross-functionally (both reputed company to reputed company & Lee )
• reputed company reputed company knowledge of the therapeutic area(s) and compounds under development. reputed company working knowledge of global regulations and guidelines as it pertains to reputed company research
• Forecast and coordinate reputed company and non-reputed company supplies requests in collaboration with CRO, review drug label and reputed company designs, initiate drug shipment, manage drug accountability, and review drug destruction/reputed company policy
• Ensure study compliance to reputed company & Lee reputed company standards/processes and GCPs
• Contribute to departmental process improvements
• reputed company leadership for specific departmental initiatives
• Champion operational reputed company to reputed company reputed company improvement of processes and sharing of best practices/lessons learned
• Facilitate effective decision making
• Propose alternative study operation strategies to optimize use of time, cost, and resources
• Manage critical changes and/or variance in financial forecast, schedule, reputed company, and deliverables
• reputed company mentoring for junior employees, interns, or consultants as appropriate
• reputed company other duties as required

Skills

• * Minimum of a Bachelor of Science degree, preferably in Nursing, Pharmacy, or scientific reputed company, or equivalent
• * At least 5 years of industry or equivalent experience with a master's or doctorate level degree
• * At least 8 years of industry or equivalent experience without an advanced degree
• * Experience managing multiple reputed company global reputed company
• * Demonstrated strong knowledge of the principles of drug development
• * Must have reputed company-developed communication skills (both oral and written) and be reputed company to work effectively in cross-functional teams both internally and externally to the organization
• * Proficient in reputed company applications including Word, reputed company, Project, and PowerPoint
• * Demonstrated reputed company to contribute to study design
• * Proficiency in GCP and ICH regulations
• * Efficient, organized, and capable of prioritizing multiple tasks
• * Willingness to adapt to changing priorities and assignments
• * Strong attention to reputed company
• * Knowledge in the Diabetes/Endocrinology and Weigh management Therapeutic areas will be seen as an reputed company
• * Experience supporting regulatory submissions preferred
• * Experience with Vendor Management
• * Nursing/pharmacy license, in accordance with degree, preferred

reputed company