Senior Clinical Study Manager – Device
Convatec
Global Feasibility Manager
Amgen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $111,710 - $132,137 per year
Job Level
SeniorLead
About the role
- Own the development and execution of the feasibility strategy in partnership with clinical program team, global study management and cross-functional data teams to deliver a fully-optimized operational action plan
- Lead the successful delivery of the feasibility process (strategy plans, country selection, site identification, timelines, synthesis of feasibility insights) to expedite cycle times for all clinical programs assigned
- Lead activities pertaining to country and site identification, feasibility and country selection within a clinical study
- Partner with study team members, data analytics team and country teams to design and conduct global feasibility activities on time with high quality delivery
- Ensure consistency of feasibility execution across the portfolio/pipeline including bridging gaps between local/central data
- Ensure clear timelines and expectations are aligned and communicated between data providers and study teams to expedite data insight deliverables and confirm the analysis timeline is coordinated with study team decision milestones.
- Confirm the Global Feasibility Strategy includes relevant data insights and/or appropriate engagement from the Enrollment Lab, to support the successful operational execution of the Diversity Action Plans (where appropriate)
- Lead the collection of local internal and external data (e.g. local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population, operational barriers) to define an optimal geographic country footprint and proposed sites for participation in a clinical study.
- In partnership with internal partners- synthesize, interpret and integrate data and information to provide clear feasibility recommendations to further embed data-driven decision making, analyze trends, identify root causes, and provide actionable recommendations across study teams and programs to accelerate study execution
- Drive operational readiness (funding status, resourcing triggers (CRAs, data teams, etc.)
- Facilitate the study baseline commitment & change process (country and study levels)
- Initiate and lead global feasibility continuous improvement efforts and initiatives
- Support development of systems, processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility (country, site) as well as the timing of key recruitment achievements.
Requirements
- Doctorate degree OR Master’s degree & 2 years of directly related experience or equivalent, OR Bachelor’s degree & 4 years of directly related experience or equivalent, OR Associate’s degree & 8 years of directly related experience or equivalent, OR High school diploma / GED & 10 years of directly related experience
- M.D., D.O., PhD, PharmD, Master’s Degree
- 10+ years’ work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical, or CRO company
- Feasibility experience and/or Country clinical operations experience
- Understands how data and analytics can inform study design and operational planning.
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data analysisclinical trial managementfeasibility strategy developmentoperational planningsite identificationcountry selectiondata synthesistrend analysisroot cause analysisprogram feasibility assessment
Soft skills
leadershipcommunicationcollaborationproblem-solvingorganizational skillsdecision makingstrategic thinkingproject managementadaptabilitycontinuous improvement
Certifications
M.D.D.O.PhDPharmD
