Manager, Global Medical Affairs Research - Phase 4
6 Months
Foster City, CA
We are seeking a Manager within Phase 4 Research in LIVE (liver, inflammation, emerging viruses, and established products) to join our Global Medical Affairs Research team. This role is responsible for coordinating proposal reviews and supporting portfolio management of investigator-sponsored research (ISR), collaborative research, and MA-led client's sponsored research across LIVE. The ideal candidate will have previous experience in Phase 4 research or clinical operations, and knowledge of the therapeutic area.
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:
o Coordinate proposal review meetings with RC Team Leads and RC Chairs
o Support creation and management of requests for proposals (RFPs)
o Support external investigators, MA scientific leads, Medical Scientists, and other stakeholders in developing and submitting rigorous research proposals
• 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 (eg, PhD, PharmD); OR master's degree (eg, 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
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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