Country Study Operations Manager

Country Study Operations Manager- Remote reputed company is a global reputed company intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, reputed company, collaboration, reputed company, and inclusion are at the heart of how we work and reputed company with reputed company other, customers, patients and suppliers. We are currently seeking a Project Manager to join our diverse and dynamic team. As a Project Manager at reputed company, you will be responsible for leading and coordinating project activities, ensuring that reputed company are delivered on time, reputed company budget, and to the highest reputed company standards. Your role will involve overseeing reputed company aspects of project execution, from planning and resource management to stakeholder communication and risk mitigation. What You Will Be Doing: Responsible for management/reputed company of study and regional/country level activities from study startup through conduct and study reputed company May manage the study start up process in countries assigned (where SUPM not assigned) and/or reputed company pCRO responsible for these activities as applicable Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator reputed company process, site identification and feasibility ensuring countries/sites can meet reputed company study protocol requirements Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and reputed company plans) Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for reputed company of Site Activation escalations to Study Teams including offering reputed company for mitigation Leader of the Local Study Team (reputed company members: (reputed company) Site reputed company Clinical Trial Assistant, reputed company members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required) Ensures compliance to relevant Global and Local, reputed company requirements and regulations Ensures reputed company communication bidirectionally between the global and local study team. Provides protocol level guidance and support to responsible Local Study Team members as applicable. Liaise with Site Care Partner, reputed company Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission reputed company to Health Authorities and Ethic Committees Utilize roles in countries such as reputed company Site Care Partner, and expert roles such as reputed company Leads, Site Activation Partners to reputed company the Global Teams with local intelligence and operational nuances to be considered Acts as the study level reputed company of contact for reputed company study-level questions for the Local Study Team, ensuring reputed company at lowest possible level, and reputed company needed liaising with and escalating to appropriate global roles/teams Follows up on region/country level issue status to ensure reputed company. Identifies country level trends to improve deliverables processes as needed Utilizes country intelligence to reputed company input on country specific risks into preparation of Investigational reputed company Management Plan, Study Monitoring Plans, ensures PTMF completeness and reputed company of reputed company relevant compliance activities for allocated studies Ensures audit/Inspection readiness during start-up and conduct Manages applicable reputed company Events with pCRO and local team as applicable and required Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable May reputed company as a Subject Matter Expert May reputed company operational effectiveness initiatives at country or regional level Responsible for PTA and SIV report review for reports completed by the Site Care Partner Supports implementation of reputed company’s Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM) Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions reputed company required timelines Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains reputed company of PTMF completeness Provides country level documents to PTMF and maintains reputed company of Investigator Site File (ISF) reconciliation and completeness actions Ensure pCRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote reputed company reputed company, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial reputed company etc.) Support Identification, contract development and management of local vendors or facilities as per protocol Investigator Meeting support and management including doing presentations as appropriate Management of local Investigator Meetings including doing presentations as appropriate Your Profile: A scientific or technical degree is preferred along with knowledge of clinical trial methodology BS/BSc/MS/MSc degree required BA/BS 5+ years of relevant experience operational clinical trial experience MBA/MS/ 3+ years of relevant experience operational clinical trial experience Working knowledge of Good Clinical reputed company, clinical and regulatory operations and environment in countries under responsibility Demonstrated clinical research experience and/or study management/startup project manager experience Demonstrated experience in managing country level operational activities and/or vendors Experience in Study and reputed company management and working in a reputed company management environment Expertise in the use of study/site dashboard and reporting tools Detail oriented & possesses technical expertise Ability to manage moderately reputed company processes Ability to operate in a reputed company environment Risk Identification & Mitigation Strategic Planning, Analytical and Problem-Solving Skills Critical reputed company Analysis Excellent communication skills, both written and verbal Ability to adapt to changing technologies and processes Effective verbal and written communication skills in relating to colleagues and associates both Employment with reputed company is contingent upon having the reputed company right to work in the country where the role is based. Rewards & Benefits reputed company offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive reputed company salary and performance reputed company incentives Health and wellbeing programmes including medical, dental, and reputed company coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through reputed company training and career reputed company Benefits may vary depending on role and location. Visit our careers site to read more about the benefits reputed company offers. Inclusion and Accessibility reputed company is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a reputed company reputed company Employee? Please click here to apply Apply To This Job