Study Operations Manager II (or Senior SOM) – Turkey

Description

Study Operations Manager II (or Senior SOM) – Turkey

Single Sponsor (FSP)

Homebased anywhere in Turkey

Study Management / Startup Oversight / Project Manager experience is a must

Job responsibilities

• Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close
• May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable
• Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all 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 quality 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 resolution of Site Activation escalations to Study Teams including offering options for mitigation
• Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc 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, internal and external requirements and regulations
• Ensures timely 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, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees
• Utilizes roles in country such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
• Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
• Follows up on region/country level issue status to ensure resolution
• Identifies country level trends to improve deliverables processes as needed
• Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring 

Qualifications

What we’re looking for

• Demonstrated clinical research experience and/or study management/startup project manager experience
• Demonstrated knowledge of site selection, site activation, site readiness interdependencies
• Demonstrated knowledge of clinical trial methodology and the drug development process
• Demonstrated experience participating on cross functional teams

Plus: 

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Ability to lead and align teams in the achievement of project milestones
• Capable of working in an international environment
• Previous clinical trial experience in site management
• Preferred experience with risk-based monitoring and clinical or central monitoring 
• Familiar with financial principles and budget management practices
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills
• Good communication, presentation and interpersonal skills among project team and with sites
• Basic conflict resolution skills
• Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
• Moderate travel may be required, approximately 20%

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