Take Care Of Others

LocalStudyOperationsLineManager

Bucharest, Romania; Iasi, Romania FULL TIME Remote Friendly
The Brief

“Local Study Operations Line Manager at Take Care Of Others. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. lead the skill development of Local Study Operations Managers. ensuring effective trial implementation within the country”

What You'll Achieve.

ensuring effective trial implementation within the country; alignment with global strategies; optimal clinical research environment that supports global R&D objectives; high-quality study execution; portfolio targets are met within the country; successful delivery of the country portfolio; operational efficiency

Industry & Context.

Problems you'll solve

support issue escalation and resolution for LSOMs; driving solutions; Proactively evaluate risks, quality trends, and resource implement mitigation strategies

What They're Looking For.

Must Have

Doctorate degree & 2 years of clinical execution experience, Master’s degree & 6 years of clinical execution experience, Bachelor’s degree & 8 years of clinical execution experience, Associate’s degree & 10 years of clinical execution experience, High school diploma / GED & 12 years of clinical execution experience, minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Nice to Have

7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, Experience managing multiple teams / direct reports across multiple clinical functions / trials, Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc. ), Experience managing clinical operations across relevant geography / region, including understanding of local regulatory requirements around global clinical trials

What You'll Do.

lead the skill development of Local Study Operations Managers

ensuring effective trial implementation within the country

alignment with global strategies

oversee the delivery of the country’s study portfolio

and sustain an optimal clinical research environment

drive alignment and continuous improvement in LSOM execution

integrating best practices

promoting digital innovation

facilitating robust knowledge sharing

Ensure the successful delivery of the study portfolio assigned to LSOMs

Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio

from feasibility through to study close-out

Monitor portfolio progress

provide risk and quality oversight

support issue escalation and resolution for LSOMs

Manage LSOM and LSOM vendor performance

guarantee high-quality study execution

serving as the primary escalation point for local study challenges

ensuring portfolio targets are met within the country

and support the professional development of LSOMs

Build and maintain a high-performing team

Facilitate close collaboration between the study strategy team and local study teams

Promote cross-functional collaboration among country teams

Support discussions regarding study placement decisions

Proactively evaluate risks

and resource implement mitigation strategies

drive continuous improvement in country operations

Lead initiatives to enhance operational efficiency

encourage sharing of best practices

Manage resource allocation and workload distribution across LSOMs

Ensure adherence to regulatory and quality standards

Collaborate with and support the country head in engaging cross-functional stakeholders

aligning on trial deliverables

How You'll Work.

Team & Collaboration

Working in close partnership with the Country GSSO Head; Facilitate close collaboration between the study strategy team and local study teams; Promote cross-functional collaboration among country teams; Collaborate with and support the country head in engaging cross-functional stakeholders

Process & Methodology

managing scope, timelines, and budgets, leadership experience leading teams, projects, programs, or directing the allocation of resources, managing multiple teams / direct reports across multiple clinical functions / trials, managing clinical operations

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