[Remote] Clinical Research Manager (CRM) Lead - Remote

Note: The job is a remote job and is open to candidates in USA. Merck is a leading global healthcare company dedicated to improving health and well-being. They are seeking a Clinical Research Manager (CRM) Lead who will be responsible for overseeing clinical trials and ensuring compliance with regulations while managing a team of CRMs. This role is critical for developing key talents within 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, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally
• Accountable to develop operational strategies and quality plans for the conduct of all programs and studies in the TA portfolio
• Collaborates with other TA directors, local and regional stakeholder in GCTO in order to develop and build territory of principal investigators and sites
• Ensures oversight and line management of Clinical Research Manager (CRM) team
• Oversee the performance management and career development of staff and effectively manage performance issues
• Lead a team 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 develop the pipeline, while maintaining regulatory requirements and compliance
• Main Point 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 close 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 our Company's with investigators and medical centers
• Serves local business needs as applicable in his/her country (if delegated can sign contracts 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 success 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 make decisions independently and oversee 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 Oversee TA strategy alignment and consolidate relevant information, within 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 efficiently in a remote and virtual environment
• The position requires proven strong project management skills and/or project management certification or relevant training program/close 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 enable 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 lead, analyze and creatively prepare mitigation plans and drive conflict resolution is critical
• Required to negotiate skillfully in tough situations with both internal and external groups; settle 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, vision healthcare 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