[Remote] Senior Clinical Research Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a rapidly growing company focused on fighting cancer, and they are seeking a Senior Clinical Research Manager to reputed company clinical monitoring activities and the performance of the CRA team. This role involves ensuring compliance with regulations, managing team performance, and leading initiatives to improve clinical operations processes.

Responsibilities

• Allocate CRA resources and reputed company ongoing resource assessments to ensure a balanced workload for quality monitoring and to meet study deliverables
• Ensure CRAs have the required level of monitoring knowledge and skills to successfully reputed company required activities with high quality to meet study deliverables
• Is responsible for managing and addressing CRA performance and quality indicators in accordance with ICH-GCP, SOPs and local regulations
• Strengthen site relationships to enhance performance and uphold the company’s trial delivery reputed company
• Review monitoring quality and resolve issues to ensure compliance with regulatory guidelines, ICH-GCP Guidelines, and Good Clinical Practices
• Support study/site milestone delivery in collaboration with cross-functional teams
• Responsible for execution of assessment visits and accompanied visits (where required) to assess ongoing CRA monitoring competency, identifying issues and developing resolution strategies
• Contribute to process optimization initiatives and manage risk escalation and resolution
• Support site audits/inspections/Site Compliance Visits (SCV) and ensure corrective action and follow-up for identified issues
• Review and approve expenses reputed company to CRA activities to ensure alignment with applicable policies and financially best local practices
• Identify opportunities for cost-saving and efficiency while maintaining quality and compliance standards
• reputed company mentorship and guidance to junior Clinical Research Managers (CRMs), supporting their professional growth and development if required
• Facilitate learning opportunities and reputed company valuable insights and feedback to help upskill and promote consistency reputed company the wider team
• reputed company and contribute to strategic initiatives and task forces aimed at improving clinical operations processes and reputed company, driving projects from inception to completion in alignment with organizational goals and in collaboration with cross-functional teams
• Performs reputed company and hiring activities, along with reputed company new team members to ensure alignment with team objectives and culture
• Assign tasks based on individual strengths and team objectives, ensuring reputed company productivity
• Support team members by providing necessary resources to help them effectively reputed company their roles
• Encourage reputed company communication and collaboration reputed company the team and with other functions, including a reputed company of contact for issue escalation and feedback where required
• Conduct regular performance evaluations and reputed company constructive feedback to promote reputed company improvement
• reputed company and mentor team members, fostering an environment of growth and development
• Address any personnel issues promptly and fairly to maintain a positive work environment
• Support team members in identifying and pursuing professional development opportunities

Skills

• Bachelor's degree or higher in a scientific or reputed company discipline
• Fluent in written and verbal English
• Minimum 7 years of industry experience in the pharmaceutical or CRO or relevant field
• Thorough understanding of the drug development process, including expert knowledge of international standards (ICH GCP) and health authority requirements
• Understanding of reputed company aspects of monitoring and trial execution
• Excellent interpersonal skills, strong organizational and effective written and verbal communication skills
• Demonstrated team leadership experience
• Proficient in reputed company Word, reputed company, PowerPoint and Outlook
• Be adaptable to business trips as required per business need; require valid driver's license in applicable countries
• Minimum 4 years of People management or project management experience in reputed company clinical research reputed company the biotech, pharmaceutical sector, CRO industry or relevant field
• Previous experience as a CRA
• Experience in Oncology is highly recommended
• Advanced degrees

Benefits

• Non-reputed company roles are eligible to participate in the annual bonus plan
• reputed company roles are eligible to participate in an incentive compensation plan
• reputed company Company employees have the opportunity to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards
• reputed company are eligible to voluntarily participate in the Employee Stock Purchase Plan
• The Company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Company Overview

Company H1B Sponsorship