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New Jersey, NJ Full Time Posted by: ZS Associates Posted: Wednesday, 9 June 2021
 
 

ZS Business Consulting group delivers solutions to a broad spectrum of sales and marketing challenges. We also help our clients transform their sales and marketing strategies and organizations to improve their effectiveness. Our recommendations and solutions are based in rigorous research and analysis underpinned by deep expertise and thought leadership across the demand generation process.

ZS' R&D Excellence Practice brings together experts in Strategy, Clinical Execution, Data Sciences and Technology to empower client organizations achieve their passion for patient care, science and business success. Through our Lifecycle Evidence Strategy, Clinical Trial Optimization, Medical Affairs and Real World Evidence services, we deliver impact where it matters, from early drug development to commercialization. This role will be aligned with ZS R&D Excellence Practice Area supporting our Technology and Platform services across multiple clients.

CLINICAL CONSULTANT

ZS Consultants support our clients clinical research activities and ensure productivity and efficiency in their research operations.

Responsibilities:

Leverage knowledge of Life Sciences R&D organizations, data and systems, business processes and stakeholder types to aid analyses and recommendations for strategic solution offerings;
Have a significant direct client interaction, managing multiple projects simultaneously;
Apply advanced analytics (predictive and prescriptive) and data management knowledge on clinical data sources (both internal CDMS & CTMS and real world data) to provide insights for Clinical Trial Optimization;
Represent R&D business in Clinical Trial Optimization and drive innovation, business case development, and lead user needs assessment workshops and roadmap development for existing and new opportunities;
Build ongoing client relationships with key business users and leaders including client presentations
Manage and advise the clinical needs assessment and requirements gathering process by meeting with stakeholders to define the business and functional requirements following user centric design best practices;
Drive methodology and frameworks for Clinical Trial Optimization solutions
Advise on clinical business process enhancements based on experience/best practices, business knowledge, and gaps in current vs. future state;
Coach the cross-functional project team 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

Qualifications:

MBA with bachelors (and often graduate) degrees with a strong academic record in business, medical or life sciences, engineering, applied math, statistics or related fields. Alternately, candidates may possess a Masters (preferably PhD) in pharmaceutical sciences, decision sciences or related field with a business application. In lieu of an MBA or PhD, 5-8 years of relevant work experience may substitute;
Up to 3 years of post-MBA relevant work experience, and 3-5 years of pre-MBA work experience in the Life Sciences industry with R&D expertise;
Expertise in the areas of clinical research coordination, operations, risk based and centralized monitoring analytics;
Knowledge of patient centricity in drug development (patient care eco-system, recruitment process, consent process, patient communication etc.)
Hands on experience working with eClinical systems and data including CTMS, EDC, ePRO, CDMS, IVR, clinical registries and real world data (RWD).
Experience support study managers working with CROs and/or working within a CRO or clinical study vendor organization
Experience managing, developing and coaching team members
Working knowledge of data standards like CDISC (ODM, SDTM, ADaM), OMOP and metadata management models like ISO11179 etc. and international regulations including 21CFR Part 11 and HIPAA
Additional skills:

Understanding of Pharmacovigilance and Drug Safety, clinical submissions and regulatory areas of drug development
Up to speed with latest industry trend in pragmatic interventional trials, hybrid data collection process, and data management with Clinical and R&D specifically.
Superior verbal and written communication, organization, analytic, planning and leadership skills.
Ability to distill complex concepts into easy-to-understand frameworks and presentations.
Willingness to travel to other global offices as needed to work with client or other internal project teams.


New Jersey, NJ, United States of America
Healthcare
Graduate
ZS Associates
Click apply
JS7750_8307874
6/9/2021 11:41:55 PM


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