Clinical Research Manager

Clinical Research Manager Qualifications Skills Experience This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH GCP and country regulations our company s policies and procedures quality standards and adverse event reporting requirements internally and externally The CRM could be responsible for a particular study for several countries in a cluster Responsibilities include but are not limited to 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 Accountable for performance for assigned protocols in a country in compliance with ICH GCP and country regulations our policies and procedures quality standards and adverse event reporting requirements internally and externally o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and or functional vendor and internal management as needed o 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 CTC CRAs and COM 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 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 with investigators 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 TAH and Regional Operations Collaborates internally with HQ functions regional and local operations EU Clinical Development Pharmacovigilence Global Medical Affairs to align on key issues decisions across the trials Consult with GHH as needed Qualifications Skills Experience CORE Competency Expectations Knowledge in Project Management and site management Strong organizational skills with demonstrated success required Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support oversight and supervision of the TA Head or CRD Requires strong understanding of local regulatory environment Strong scientific and clinical research knowledge is required Strong understanding of clinical trial planning management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously Experience functioning as a key link between Country Operations and Clinical Trial Teams Communicates effectively and builds a collaboration spirit in a remote virtual environment and across countries cultures and functions Ability and skills to manage resource allocation processes and controls productivity quality and project delivery Proficiency in written and spoken English and local language The incumbent must be competent and effective in written and verbal communication Strategic thinking Ability to work efficiently in a remote and virtual environment Understand cultural diversity The position requires proven strong project management skills and or project management certification or relevant training program close mentoring Behavioural Competency Expectations 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 analyse and prepare mitigation plans and drive conflict resolution is critical Required to negotiate skilfully 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 Experience Requirements Required 5-6 years of experience in clinical research CRA Experience preferred Educational Requirements Required Bachelor degree in Science or comparable Preferred Advanced degree e g Master degree MD PhD Note Up to 30 of working time for travelling if required Current Employees apply Current Contingent Workers apply Search Firm Representatives Please Read Carefully Merck Co Inc Rahway NJ USA also known as Merck Sharp Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities All CVs resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place Where agency agreements are in place introductions are position specific Please no phone calls or emails Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material s Required Skills Adaptability Adaptability Business Relationship Building Clinical Data Management Clinical Information Systems Clinical Medicine Clinical Research Clinical Site Management Clinical Testing Clinical Trial Management Processes Clinical Trials Monitoring Conflict Resolution Decision Making Good Clinical Practice GCP Identifying Problems Management Process Project Management Project Support Quality Control Management Quality Management Regulatory Issues Regulatory Submissions Resource Allocation Risk Based Monitoring Risk Management 5 more Preferred Skills Job Posting End Date 09 30 2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date Please ensure you apply to a job posting no later than the day BEFORE the job posting end date