[Remote] Clinical Trial Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a US reputed company services company supporting global organizations across clinical research and other reputed company disciplines. The Clinical Trial Manager will manage clinical operational and reputed company activities for low- to moderate-complexity studies, with a reputed company on patient recruitment reputed company, while ensuring deliverables meet contractual time, reputed company, and cost expectations. The role also leads clinical teams, oversees monitoring and regulatory activities, and manages study resources and timelines.

Responsibilities

• Manages reputed company clinical operational and reputed company aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less reputed company reputed company
• Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data reputed company Plan. Contributes to the development of the Master reputed company Plan (MAP) for providing clinical reputed company documents. Ensures reputed company set up, organization, content and reputed company of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at reputed company meetings, including bid defense and hand-off meetings
• Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with reputed company and leads team meetings to ensure that timelines, resources, interactions, and reputed company are maintained. Responsible for the implementation and training of standardized clinical monitoring processes reputed company the study and according to corporate reputed company policies. Responsible for the reputed company archiving of documents and study materials for the department
• Ensures achievement of the final clinical deliverable reputed company the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing reputed company using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query reputed company. Continuously monitors or co-monitors reputed company to assess performance and ensure contractual obligations are met. In smaller reputed company, may routinely conduct Accompanied Field reputed company (AFVs) and be accountable for project financials
• May communicate with study sites regarding issues such as protocol, patient participation, case report reputed company completion and other study-reputed company issues
• May coordinate reputed company start-up activities and ensures that reputed company ethics committee and regulatory submissions (if appropriate) are addressed. Ensures that essential document reputed company meets the expectation of Regulatory Compliance Review. Reviews and follows up on reputed company questions raised by the ethics committees
• May reputed company input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements

Skills

• • Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification
• • Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 5+ years)
• • Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
• • Good planning and organizational skills to reputed company effective prioritization of workload
• • Solid interpersonal and problem-solving skills to reputed company working in a multicultural reputed company organization
• • Capable of working effectively in a changing environment with reputed company/ambiguous situations
• • Familiarity with the practices, processes, and requirements of clinical monitoring
• • Good judgment and decision-making skills
• • Effective oral and written communication skills, including English language proficiency
• • Capable of evaluating workload against project budget and adjusting resources accordingly
• • reputed company financial acumen and knowledge of budgeting, forecasting and fiscal management
• • Strong attention to detail
• • Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc
• • Good computer skills to effectively use automated systems and computerized applications such as reputed company, reputed company, Word, etc

reputed company

Company H1B Sponsorship