ZS
Strategy Insights & Planning Consultant - Clinical Operations
ZS, Boston, Massachusetts, us, 02298
ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by
bringing together data, science, technology
and
human ingenuity
to deliver better outcomes for all. Here you’ll work side-by-side with a powerful collective of thinkers and experts shaping life‑changing solutions for patients, caregivers and consumers worldwide.
Strategy Insights & Planning Consultant – R&D Drug Development ZS’s Insights & Analytics group partners with clients to design and deliver solutions to help them tackle a broad range of business challenges. Our teams work on multiple projects simultaneously, leveraging advanced data analytics and problem‑solving techniques. Our recommendations and solutions are based on rigorous research and analysis underpinned by deep expertise and thought leadership.
What You’ll Do
Contribute clinical operations expertise to internal knowledge development and capability building in areas such as Good Clinical Practice (GCP), ICH guidelines, and trial risk monitoring
Advise on R&D business process enhancements based on experience/best practices, business knowledge, and gaps in current vs. future state in one or more of the following R&D domains: Clinical, Quality, Regulatory, and/or Safety
Lead project delivery execution by ensuring progress, organizing project data and coordinating team meetings focused on:
Clinical data quality and management
Site performance and trial efficiency
Operational risk mitigation and process optimization
Global Clinical operations
Biometrics
Design and execute qualitative and/or quantitative analyses to test and analyze hypotheses (e.g., stakeholder interviews, operational data reviews, workshops, risk analysis) to generate actionable insights
Synthesize findings, develop recommendations and communicate results to clients and internal teams
Support internal capabilities and client business development
Coach cross‑functional, regional and global project teams on the business perspective and data domain to inform key project decisions
Coach and mentor teams, conduct & develop training programs to contribute to capability building and knowledge sharing
What You’ll Bring
MBA with bachelor’s (and often graduate) degrees with a strong academic record in Life Sciences, Public Health or related field. Alternatively, candidates may possess a PhD in a related field with a business application. In lieu of an MBA or PhD, 5‑8 years of relevant work experience may substitute
Preferred: At least 5 years of experience in clinical operations consulting or operational roles within pharma/biotech
Preferred: Hands‑on experience in one or more areas:
Clinical trial management
Data management and analytics
Drug development process consulting
Biostatistics or precision medicine
eCTD content authoring
Human bio‑sample management
Global clinical operations
Preferred: Experience with end‑to‑end SaaS implementation, Product Management, and/or GxP Product Validation and Testing for one or more of the CTMS, EDC, eTMF, EHR/eSource, QMS, RIM, SIS
Strong knowledge of clinical processes across functions such as regulatory, safety, quality, GCO and biostatistics
Motivation, good work ethic, maturity and personal initiative
Aptitude for, and enjoyment of, leading and managing teams
Effective oral and written communication skills that enable personal impact with senior‑level decision makers
Empathy, adaptability and high personal impact
Strong attention to detail, with a quality‑focused mindset
Analytic problem‑solving skills, with a creative and innovative outlook
Client service orientation
Fluency in English
Client‑first mentality
Intense work ethic
Collaborative spirit and problem‑solving approach
How you’ll grow
Cross‑functional skills development & custom learning pathways
Milestone training programs aligned to career progression opportunities
Internal mobility paths that empower growth via s‑curves, individual contribution and role expansions
Hybrid working model ZS is committed to a Flexible and Connected way of working. ZSers are onsite at clients or ZS offices three days a week. Combined flexibility to work remotely two days a week is also available. The magic of ZS culture and innovation thrives in both planned and spontaneous face‑to‑face connections.
Travel is a requirement for client‑facing ZSers; the business needs of your project and client are the priority. While some projects may be local, all client‑facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.
Find Out More At: www.zs.com
#J-18808-Ljbffr
bringing together data, science, technology
and
human ingenuity
to deliver better outcomes for all. Here you’ll work side-by-side with a powerful collective of thinkers and experts shaping life‑changing solutions for patients, caregivers and consumers worldwide.
Strategy Insights & Planning Consultant – R&D Drug Development ZS’s Insights & Analytics group partners with clients to design and deliver solutions to help them tackle a broad range of business challenges. Our teams work on multiple projects simultaneously, leveraging advanced data analytics and problem‑solving techniques. Our recommendations and solutions are based on rigorous research and analysis underpinned by deep expertise and thought leadership.
What You’ll Do
Contribute clinical operations expertise to internal knowledge development and capability building in areas such as Good Clinical Practice (GCP), ICH guidelines, and trial risk monitoring
Advise on R&D business process enhancements based on experience/best practices, business knowledge, and gaps in current vs. future state in one or more of the following R&D domains: Clinical, Quality, Regulatory, and/or Safety
Lead project delivery execution by ensuring progress, organizing project data and coordinating team meetings focused on:
Clinical data quality and management
Site performance and trial efficiency
Operational risk mitigation and process optimization
Global Clinical operations
Biometrics
Design and execute qualitative and/or quantitative analyses to test and analyze hypotheses (e.g., stakeholder interviews, operational data reviews, workshops, risk analysis) to generate actionable insights
Synthesize findings, develop recommendations and communicate results to clients and internal teams
Support internal capabilities and client business development
Coach cross‑functional, regional and global project teams on the business perspective and data domain to inform key project decisions
Coach and mentor teams, conduct & develop training programs to contribute to capability building and knowledge sharing
What You’ll Bring
MBA with bachelor’s (and often graduate) degrees with a strong academic record in Life Sciences, Public Health or related field. Alternatively, candidates may possess a PhD in a related field with a business application. In lieu of an MBA or PhD, 5‑8 years of relevant work experience may substitute
Preferred: At least 5 years of experience in clinical operations consulting or operational roles within pharma/biotech
Preferred: Hands‑on experience in one or more areas:
Clinical trial management
Data management and analytics
Drug development process consulting
Biostatistics or precision medicine
eCTD content authoring
Human bio‑sample management
Global clinical operations
Preferred: Experience with end‑to‑end SaaS implementation, Product Management, and/or GxP Product Validation and Testing for one or more of the CTMS, EDC, eTMF, EHR/eSource, QMS, RIM, SIS
Strong knowledge of clinical processes across functions such as regulatory, safety, quality, GCO and biostatistics
Motivation, good work ethic, maturity and personal initiative
Aptitude for, and enjoyment of, leading and managing teams
Effective oral and written communication skills that enable personal impact with senior‑level decision makers
Empathy, adaptability and high personal impact
Strong attention to detail, with a quality‑focused mindset
Analytic problem‑solving skills, with a creative and innovative outlook
Client service orientation
Fluency in English
Client‑first mentality
Intense work ethic
Collaborative spirit and problem‑solving approach
How you’ll grow
Cross‑functional skills development & custom learning pathways
Milestone training programs aligned to career progression opportunities
Internal mobility paths that empower growth via s‑curves, individual contribution and role expansions
Hybrid working model ZS is committed to a Flexible and Connected way of working. ZSers are onsite at clients or ZS offices three days a week. Combined flexibility to work remotely two days a week is also available. The magic of ZS culture and innovation thrives in both planned and spontaneous face‑to‑face connections.
Travel is a requirement for client‑facing ZSers; the business needs of your project and client are the priority. While some projects may be local, all client‑facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.
Find Out More At: www.zs.com
#J-18808-Ljbffr