[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.ResponsibilitiesAccountable for the successful execution, enrollment and quality of their clinical trial portfolioAccountable 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 externallyAccountable to develop operational strategies and quality plans for the conduct of all programs and studies in the TA portfolioCollaborates with other TA directors, local and regional stakeholder in GCTO in order to develop and build territory of principal investigators and sitesEnsures oversight and line management of Clinical Research Manager (CRM) teamOversee the performance management and career development of staff and effectively manage performance issuesLead a team independently with supervision from CRD/TAH to high performanceAccountable for CRM performance reviews, including addressing low performance situations, and taking appropriate actionsEnsures key talent development and retentionCollaborates internally with the cross-functional teams on local, regional and global levelCollaborates externally with investigators, regulators and vendorsSupports strategic initiatives across country, Global Clinical Development GCD and GCTOSupports local strategy development consistent with long-term corporate needs in conjunction with CRDTogether with direct reports contributes significantly to effective conduct of clinical studies and to develop the pipeline, while maintaining regulatory requirements and complianceMain 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 outReviews 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 requiredLeads 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 studiesEnsures compliance with CTMS, eTMF and other key systems in assigned studiesEscalates 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, clustersMay act as a mentorResponsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studiesCountry POC for programmatically outsourced trials for assigned protocolsAs a customer-facing role, this position will build business relationships and represent our Company's with investigators and medical centersServes 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 OperationsSkills10+ years of experience in clinical research with demonstrated success and increasing responsibilities of which 5+ years consisted of leading projects and teamBachelor 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 levelRequires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitmentsStrong scientific and clinical research knowledge is required. Including extensive knowledge of regional and/or country clinical trial landscapeDeep 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 TeamsAbility, 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 accordinglyProficiency in written and spoken English and local language. The incumbent must be Strategic thinkingAbility to work efficiently in a remote and virtual environmentThe position requires proven strong project management skills and/or project management certification or relevant training program/close mentoringHigh emotional intelligenceAbility to focus on multiple deliverables and protocols/projects simultaneouslyExercise strategic thinking and executes effectively across projectsFosters understanding of cultural diversityStrong leadership skills that enable and drive alignment with the goals, purpose and mission of our Research & Development Division, Global Clinical Development (GCD) and GCTOAbility to identify problems, conflicts and opportunities early and lead, analyze and creatively prepare mitigation plans and drive conflict resolution is criticalRequired 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 situationsEducational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholdersCRA Experience preferredAdvanced degree (e.g.,Master degree, MD, PhD)BenefitsAnnual bonus and long-term incentive, if applicableMedical, dental, vision healthcare and other insurance benefits (for employee and family)Retirement benefits, including 401(k)Paid holidays, vacation, and compassionate and sick daysComprehensive package of benefitsFlexible Work Arrangements: RemoteCompany OverviewMerck is a biopharmaceutical company that offers medicines and vaccines for various diseases. It was founded in 1891, and is headquartered in Rahway, New Jersey, USA, with a workforce of 10001+ employees. Its website is http://www.merck.com.