Medical Affairs Manager Job at ACL Digital, Foster, CA

a3oyZHhoSzZVODhSSloybU0rSjBOcndpSGc9PQ==
  • ACL Digital
  • Foster, CA

Job Description

Job Title: Manager, Global Medical Affairs Research

Location: Foster City, CA

Duration: 6+ Months

Phase 4 Research in LIVE (liver, inflammation, emerging viruses, and established products)

Job Description

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 Gilead-sponsored research across LIVE. The ideal candidate will have previous experience in Phase 4 research or clinical operations, and knowledge of the therapeutic area.

This position is based at Client's Foster City, CA location.

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 to Gilead

• 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

Job Tags

Local area,

Similar Jobs

BlueScope Buildings

Estimator Job at BlueScope Buildings

 ...innovations. Your goals, ideas and perspective can help shape our future - we look forward to hearing them! About Us: The Estimating Department at Butler leverages industry-shaping products and innovative strategies to drive sustainable sales and financial... 

Pocketbook Agency

Personal Assistant to Entrepreneurial Couple (Phoenix) Job at Pocketbook Agency

 ...couple in Phoenix is seeking a resourceful, service-oriented Personal Assistant to support their dynamic household and daily operations. The...  .... This role will work in their home daily and has little remote work opportunity. Responsibilities: Manage personal calendars... 

Intuscare

Software Engineer, Data Migrations (Healthcare) Job at Intuscare

 ...eligible seniors some of the most socially vulnerable and clinically complex individuals in the US healthcare system About the Role This role sits on the Data Migrations team and focuses on building highquality, repeatable pipelines that move healthcare... 

NinjaTrader

Sr. Data Engineer Job at NinjaTrader

 ...in the world. What you'll do: Your data-driven mindset and ability to use large data...  ...processes. As an accomplished data engineer reporting to the Data & Analytics Director...  ...role is based in Chicago, IL. *There may be remote flexibility for exceptional candidates in... 

Providence Health and Services

Clinic Registered Nurse (RN) - Day Shift Job at Providence Health and Services

 ...Clinic Registered Nurse (RN) - Day Shift at Providence Health and Services summary: Registered Nurse (RN) provides comprehensive ambulatory nursing care in an outpatient clinic, performing assessment, care planning, implementation and evaluation across direct, telehealth...