Clinical Research

• Responsible for the full cycle of Clinical Data Management queries
• Cooperate with Clinical Data Managers, Data Coordinators, Statistical Programmers and others
• Assist and lead operations alongside Senior CDM
• Develop project documentation, system setup, data validation processes and procedures assigned to junior staff
• Work with Senior CDM to build study milestone timelines and follow study timelines for on-time deliverables
• Assist or lead internal and external DM meetings
• Manage proactively risks and resolve or escalate issues connected to Clinical Data Management improvement or technology
• Develop understanding of CDASH and SDTM or other recognized industry standards and their impact on programming teams
• Specialize in TA-specific data capture and standards, conduct lessons learned and disseminate them across the organization
• May act as a team leader or mentor Clinical Data Management colleagues and stakeholders on operational processes
• Lead project-level activities consistent with current or previous experience in support of study delivery

Associate Clinical Data Manager – FSP

• Manage and operationally deliver clinical elements of trials, including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
• Execute assigned trials successfully and ensure completion of trial deliverables
• Ensure communication, regulatory documentation, and ongoing oversight of assigned trials in collaboration with functional team members
• Mentor and train team members
• Identify challenges to study timelines and deliverables and propose creative action plans to the team or sponsor
• Lead CRAs in site relationships and oversight of monitoring, regulatory, IP, site payment, and site correspondence activities
• Maintain focus on study priorities through cross-functional partnerships and communication to achieve client satisfaction

Clinical Trial Manager

• Manage and operationally deliver clinical elements of trials, including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
• Execute assigned trials successfully and ensure completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials in collaboration with functional team members
• Mentor and train team members
• Identify challenges to study timelines and deliverables and offer creative action plans to the team and sponsor
• Lead CRAs in site relationships and oversight of monitoring, regulatory, IP, site payment, and site correspondence activities
• Maintain focus on study priorities through cross-functional partnerships and effective communication to achieve client satisfaction

• Manage and operationally deliver clinical elements within trials, including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
• Execute assigned trials successfully and ensure completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials in collaboration with functional team members
• Mentor and train team members
• Identify study timeline and deliverable challenges and offer creative action plans to the team and sponsor
• Lead CRAs in establishing site relationships and overseeing monitoring, regulatory, investigational product, site payment, and site correspondence activities
• Maintain focus on study priorities through cross-functional partnerships and communication to achieve client satisfaction

• Manage and operationally deliver clinical elements of trials, including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
• Execute assigned trials successfully and ensure completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials in collaboration with cross-functional team members
• Mentor and train team members
• Identify challenges to study timelines and deliverables and provide creative action plans to the team and sponsor
• Lead CRAs in establishing site relationships and overseeing monitoring, regulatory, IP, site payment, and site correspondence activities
• Maintain focus on study priorities through cross-functional partnerships and communication to achieve client satisfaction

• Manage and operationally deliver clinical elements of trials, including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
• Execute assigned trials successfully and ensure completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials in collaboration with cross-functional team members
• Mentor and train team members
• Identify challenges to study timelines and deliverables and propose creative action plans to the team and sponsor
• Lead CRAs in establishing site relationships and overseeing monitoring, regulatory, investigational product, site payment, and site correspondence activities
• Maintain focus on study priorities through cross-functional partnerships and effective communication to achieve client satisfaction
• Serve as the central intelligence hub for managed studies and lead CRAs across multiple countries

• Manage and operationally deliver clinical elements within trials, including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
• Execute assigned trials successfully and ensure completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials in collaboration with cross-functional team members
• Mentor and train team members
• Identify challenges to study timelines and deliverables and develop creative action plans for the team and sponsor
• Lead CRAs in establishing site relationships and overseeing monitoring, regulatory, investigational product, site payment, and site correspondence activities
• Maintain team focus on study priorities through cross-functional partnerships and effective communication to achieve client satisfaction

• Manage and operationally deliver clinical elements of trials, including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
• Execute assigned trials successfully and ensure completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials in collaboration with functional team members
• Mentor and train team members
• Identify challenges to study timelines and deliverables and propose creative action plans to the team and sponsor
• Lead CRAs in site relationships and oversight of monitoring, regulatory, IP, site payment, and site correspondence activities
• Maintain focus on study priorities through cross-functional partnerships and communication to achieve client satisfaction

• Manage and operationally deliver clinical elements within trials, including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
• Execute assigned trials successfully and ensure completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials in collaboration with functional team members
• Mentor and train team members
• Identify challenges to study timelines and deliverables and develop creative action plans for the team and sponsor
• Lead CRAs in establishing site relationships and overseeing monitoring, regulatory, IP, site payment, and site correspondence activities
• Maintain team focus on study priorities through cross-functional partnerships and effective communication to achieve client satisfaction
• Serve as the central intelligence hub for managed studies and oversee clinical aspects across multiple countries

• Manage and operationally deliver clinical elements within trials, including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
• Execute assigned trials successfully and ensure completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials in collaboration with functional team members
• Mentor and train team members
• Identify challenges to study timelines and deliverables and propose creative action plans to the team and sponsor
• Lead CRAs in establishing site relationships and overseeing monitoring, regulatory, investigational product, site payment, and site correspondence activities
• Maintain focus on study priorities through cross-functional partnerships and effective communication to achieve client satisfaction
• Serve as the central intelligence hub for managed studies and lead CRAs across multiple countries