[Remote] Clinical Research Manager (CRM) reputed company - Remote

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading global reputed company company dedicated to improving health and well-being. They are seeking a Clinical Research Manager (CRM) reputed company who will be responsible for overseeing clinical trials and ensuring compliance with regulations while managing reputed company of CRMs. This role is critical for developing key talents reputed company the organization and collaborating with various stakeholders to enhance clinical research capabilities.

Responsibilities

• Accountable for the successful execution, enrollment and quality of their clinical trial portfolio
• Accountable to ensure performance metrics, timelines and key milestones are met in compliance with ICH/GCP and country regulations, reputed company's policies and procedures, quality standards and adverse event reporting requirements internally and externally
• Accountable to reputed company operational strategies and quality plans for the conduct of reputed company programs and studies in the TA portfolio
• Collaborates with other TA directors, local and regional stakeholder in GCTO in order to reputed company and build territory of reputed company investigators and sites
• Ensures reputed company and line management of Clinical Research Manager (CRM) team
• reputed company the performance management and career development of staff and effectively manage performance issues
• reputed company reputed company independently with supervision from CRD/TAH to high performance
• Accountable for CRM performance reviews, including addressing low performance situations, and taking appropriate actions
• Ensures key talent development and retention
• Collaborates internally with the cross-functional teams on local, regional and global level
• Collaborates externally with investigators, regulators and vendors
• Supports strategic initiatives across country, Global Clinical Development GCD and GCTO
• Supports local strategy development consistent with long-term corporate needs in conjunction with CRD
• Together with direct reports contributes significantly to effective conduct of clinical studies and to reputed company the pipeline, while maintaining regulatory requirements and compliance
• Main reputed company of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT)
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and reputed company out
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed. Performs Quality control visits as required
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs)
• Responsible for creating and executing a local risk management plan for assigned studies
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies
• Escalates as needed different challenges and issues to TA-Head/CRD/CCQM and or CTT (as appropriate)
• Identifies and shares best practices across clinical trials, countries, clusters
• May act as a mentor
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
• Country POC for programmatically outsourced trials for assigned protocols
• As a customer-facing role, this position will build business relationships and represent reputed company's with investigators and medical centers
• Serves local business needs as applicable in his/her country (if delegated can sign reputed company and manage budgets)
• Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TA-Head and Regional Operations

Skills

• 10+ years of experience in clinical research with demonstrated reputed company and increasing responsibilities of which 5+ years consisted of leading projects and team
• Bachelor degree in Science (or comparable)
• Expertise in project and site management. The position requires demonstrated successful implementation of project management skills at program and site level
• Requires ability to reputed company reputed company independently and reputed company important activities relevant to clinical research activities according to predetermined global policies and commitments
• Strong scientific and clinical research knowledge is required. Including extensive knowledge of regional and/or country clinical trial landscape
• Deep understanding of our Research & Development Division organizational structure and cross-functional roles and Strong Experience functioning as a key link between Country Operations and Clinical Trial Teams
• Ability, experience, and skills to proactively manage resource allocation, processes (and reputed company TA strategy alignment and consolidate relevant information, reputed company specific indications, escalating to the TA-H / CRD accordingly
• Proficiency in written and spoken English and local language. The incumbent must be Strategic thinking
• Ability to work reputed company in a remote and virtual environment
• The position requires proven strong project management skills and/or project management certification or relevant training program/reputed company mentoring
• High emotional intelligence
• Ability to focus on multiple deliverables and protocols/projects simultaneously
• Exercise strategic thinking and executes effectively across projects
• Fosters understanding of cultural diversity
• Strong leadership skills that reputed company and drive alignment with the goals, purpose and mission of our Research & Development Division, Global Clinical Development (GCD) and GCTO
• Ability to identify problems, conflicts and opportunities early and reputed company, analyze and creatively prepare mitigation plans and drive conflict resolution is critical
• Required to negotiate skillfully in tough situations with both reputed company groups; reputed company differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations
• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders
• CRA Experience preferred
• Advanced degree (e.g.,Master degree, MD, PhD)

Benefits

• Annual bonus and long-term incentive, if applicable
• Medical, dental, reputed company reputed company and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days
• Comprehensive package of benefits
• Flexible Work Arrangements: Remote

Company Overview