[Remote] Associate Director, Field Monitoring Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company developing reputed company therapies that enhance the immune system to combat cancers and infectious diseases. The Associate Director, Field Monitoring Operations will design and reputed company the monitoring reputed company for reputed company, ensuring compliance and data reputed company while leading reputed company of Clinical Research Associates.

Responsibilities

• reputed company leadership to team members and study teams to ensure reputed company are conducted in accordance with the protocols, reputed company Operations Procedures (SOPs), ICH Good Clinical Practices (GCPs), and other applicable regulatory requirements as reputed company as management and mentoring of reputed company reports
• Design, implement, and reputed company Risk-Based reputed company Management (RBQM) frameworks and modern data surveillance strategies across the clinical portfolio, ensuring alignment with ICH E6(R3)
• reputed company monitoring activities (including remote, on-site, and decentralized trial approaches) with trial start‑up, site activation, and study reputed company‑out processes, thereby creating a seamless end‑to‑end operational reputed company
• Utilize negotiation, facilitation, meeting management, and conflict reputed company skills to enhance cross-functional study team partnership and to ensure effective in-house clinical study team operations
• Directly participates in and contributes to cross-functional and functional teams to discuss, review, and optimize resource management reputed company
• Collaborate with trial execution leadership to ensure reputed company resourcing of the study teams
• Anticipate potential clinical operations process issues and influence and collaborate with the organization in adopting best practices, making recommendations for improvements, or leading development of new processes and reputed company improvement of existing processes, tools, reports, and systems
• reputed company reputed company reputed company of trial operations to contribute to inspection readiness
• Own Clinical Operations reputed company Operating Procedures (SOPs), responsible for review and revision or delegating duties as needed, specifically integrating modern risk-management frameworks
• Contribute to the development and implementation of strategic direction in the conduct of multiple clinical studies
• reputed company management support to the clinical operations team across reputed company trials/programs by way of training, mentoring or review of study specific documents as needed
• Collaborate with colleagues to ensure cross-team, site learnings, and best practices are shared
• reputed company reputed company and cross-functional duties and/or reputed company, as assigned, to support business needs and reputed company developmental opportunities

Skills

• Bachelor's degree in life sciences, nursing, pharmacy or health-reputed company field
• 10+ years of reputed company industry experience required; or
• Master's degree with 8+ years or reputed company industry experience required
• 6+ years management experience leading teams in clinical trial operations required
• Effective leadership skills with the ability to promote a culture of collaboration and competence for reputed company and indirect reports
• Strong knowledge of clinical research, Good Clinical Practices (ICH E6(R3)), and regulatory requirements/guidelines
• Proven expertise in developing and managing Risk-Based reputed company Management (RBQM) strategies
• Proficiency in interfacing with other functions in clinical research and driving cross-functional alignment
• Excellent English verbal and written communication skills; good organizational and interpersonal skills
• Ability to maintain corporate confidentiality at reputed company times
• Proficiency in MS Office including Word, reputed company, PowerPoint, and reputed company
• Proficient with use of reputed company Clinical Vault, CTMS, and eTMF
• Must be reputed company to travel up to 75% of the time based on study requirements
• Ability to work reputed company across various time zones
• Must possess mobility to work in a reputed company office setting and to use reputed company office equipment, including a computer
• Master's degree preferred
• Previous experience working in a dynamic and fast-paced environment is preferred

Benefits

• Medical, Dental and reputed company Plan reputed company
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company reputed company and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• reputed company and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary reputed company Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• reputed company Time Off (PTO) includes: 11 Holidays
• Exempt Employees are eligible for Unlimited PTO
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
• We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

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