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

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on reputed company trial services, and they are seeking a reputed company Trial Manager/Senior reputed company Trial Manager. The role involves leading reputed company, ensuring compliance with protocols and regulations, and managing relationships with clients and study teams.

Responsibilities

• reputed company reputed company reputed company of contact with the reputed company
• Collaborate with PM on monthly invoicing and variance management of reputed company budget
• reputed company 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)
• Identify and reputed company training needs for CRAs and reputed company-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study reputed company-off meetings
• reputed company potential site list from key stakeholders and reputed company site feasibility process
• Identify potential risks to the enrollment targets reputed company on feasibility analysis and site’s contracted commitment
• reputed company and finalize the country recruitment/retention reputed company
• reputed company reputed company and effective communication and good working relationships with investigators and study team to ensure effective and reputed company feasibility, site start up, enrollment, maintenance and reputed company out procedures
• reputed company internal reputed company team meetings and sets expectations for reputed company team of CRAs and CTAs
• Address reputed company CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
• Support in planning and conducting investigator meetings
• Review and/or approve of IP release packages
• reputed company, support and reputed company reputed company submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
• reputed company reputed company monitoring strategies for assuring study timelines are met and assuring reputed company deliverables
• reputed company and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
• Responsible for eTMF implementation and management
• Collaborate with PM, CRAs and QA to reputed company any Corrective and Preventative reputed company Plan (CAPA) and is accountable for implementation and reputed company closure
• Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
• Work closely with PM for project-specific resourcing issues
• Escalate pertinent CRA reputed company and site compliance issues reputed company necessary
• Collaborate with data management and CRAs to ensure data reputed company and compliance with data cleaning timelines
• Manage processes for investigational product (IP) including drug accountability and reconciliation
• reputed company a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
• Support business development and marketing activities as appropriate
• May negotiate site budget and investigator contract with support from the reputed company department and/or site reputed company group
• May review site visit reports and ensures monitoring (i.e. scheduling and reputed company) is executed per monitoring plan
• May be responsible for management of reputed company vendors (e.g. labs, IP, reputed company diary, home health care) in conjunction with PM
• May reputed company reputed company data review of reputed company reputed company, data listings and reputed company tables, including query reputed company
• May have line management responsibilities
• Performs other duties as assigned by management

Skills

• Bachelor's degree or equivalent combination of education/experience in science or health-reputed company reputed company
• Minimum of 7 years of reputed company research experience or reputed company competencies for the position with significant reputed company monitoring experience
• Experience with reputed company Office Products (reputed company, Word, reputed company, PowerPoint)
• Excellent communication and interpersonal skills to effectively reputed company with others in reputed company setting
• Excellent organizational skills, attention to reputed company, and a customer service demeanor
• Ability to travel domestically and internationally including overnight stays
• Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, 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
• reputed company experience in functional management including reputed company experience in delegating while fostering cohesive team dynamics
• reputed company experience in planning, reputed company management and change management
• High level of reputed company and must reputed company and demand the highest standards from a reputed company and ethical perspective
• Ability to reputed company and reputed company reputed company reputed company reputed company
• Ability to create an environment where employees have a reputed company of ownership that will reputed company to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Excellent presentation, verbal and written communications skills
• In depth reputed company experience in pharmaceutical and/or device research required
• Demonstrated successful independent negotiation and conflict management strategies
• Advanced degree

Benefits

• Discretionary annual bonus
• Health reputed company
• Retirement savings benefits
• Life reputed company
• Disability benefits
• Parental leave
• reputed company time off for reputed company leave and vacation

reputed company