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, Company 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, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. - Reviews Monitoring Visits Reports and escalates performance issues and trainings 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 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 the 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, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed. **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 Company Research Labs, 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