Job Description

Specific Job Responsibilities:

• Assist in managing meetings for our LIVE Research Committee (RC)
• Manage reviews of ISRs, COs and MA-led Client proposals through the RC review process for:
• Coordinate proposal review meetings with RC Team Leads and RC Chairs
• Support creation and management of requests for proposals (RFPs)
• Support external investigators, MA scientific leads, Medical Scientists, and other stakeholders in developing and submitting rigorous research proposals to Client
• Support the management of the LIVE portfolio including liaising with key cross-functional partners such as Clinical Operations, local affiliates and external investigators
• Review abstracts and/or manuscripts that result from the phase 4 program
• Contribute to ensuring that the research processes and study execution align with MA research policy and governance, integrated evidence plan priorities, and overall program strategy
• Work with the team to track, monitor and intervene with external investigators to ensure timely execution of contracted studies, and support closure of studies when not meeting contracted milestones
• Act as a resource for Research Committee Chairs, voting members, standing members, proposal champions, affiliates, and reviewers
• Contribute to process improvements related to research proposal and study management systems
• Manage projects to completion, anticipating obstacles and difficulties that may arise, resolving them in a collaborative manner and engage in project management activities as needed by assigned RC Team Lead and/or Senior Manager

Educational and other Requirements:

• Professional degree (e.g PhD, PharmD); OR master’s degree (e.g., MS, MPH) with 2+ years of experience in clinical or observational research including research operations; OR Bachelor’s degree with 6-plus years of experience
• Must be cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials
• Demonstrated project management and organization skills including process improvement, management of multiple resources and priority projects with tight timelines while maintaining attention to detail
• Ability to work in a global environment which may require participation in meetings outside of standard work hours to accommodate time zone differences
• Affinity for a collaborative, team-oriented environment, and approach; must be able to appropriately interact within MA and across Development, senior management, and external customers/vendors
• Excellent interpersonal, written, and verbal communication skills
• Proven track record of executing clearly defined goals and objectives in a fast-paced environment
• Self-motivated to work independently and having a positive attitude while working as part of teams
• Ability to engage and manage multiple stakeholders to achieve the objective

Preferred Qualifications:

• Understanding/experience in in MA/pharmaceutical industry in phase4/externally sponsored research programs or Clinical Development
• Scientific knowledge/experience in LIVE TAs

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