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PwC Decentralized Clinical Trial Senior Associate in New York, New York

Specialty/Competency: Operations

Industry/Sector: Pharma and Life Sciences

Time Type: Full time

Travel Requirements: Up to 80%

A career in Product Development and Manufacturing, within Operations Consulting, will provide you with the opportunity to help organizations uncover enterprise insights and drive business results using smarter data analytics. We focus on a collection of organizational technology capabilities, including business intelligence, data management, and data assurance that help our clients drive innovation, growth, and change within their organizations in order to keep up with the changing nature of customers and technology. You’ll make impactful decisions by mixing mind and machine to leverage data, understand and navigate risk, and help our clients gain a competitive edge.

Our team helps organizations define paths to more profitable growth, from core product development to radical business innovation. As part of the team, you’ll help our clients develop new innovative businesses, products and services as well as build lasting internal capabilities, ranging from Innovation Incubators to global research and development centres to product lifecycle systems, that enable sustained, consistent results.

o really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be a purpose-led and values-driven leader at every level. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future.

As a Senior Associate, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to:

  • Use feedback and reflection to develop self awareness, personal strengths and address development areas.

  • Delegate to others to provide stretch opportunities, coaching them to deliver results.

  • Demonstrate critical thinking and the ability to bring order to unstructured problems.

  • Use a broad range of tools and techniques to extract insights from current industry or sector trends.

  • Review your work and that of others for quality, accuracy and relevance.

  • Know how and when to use tools available for a given situation and can explain the reasons for this choice.

  • Seek and embrace opportunities which give exposure to different situations, environments and perspectives.

  • Use straightforward communication, in a structured way, when influencing and connecting with others.

  • Able to read situations and modify behavior to build quality relationships.

  • Uphold the firm's code of ethics and business conduct.

Job Requirements and Preferences :

Basic Qualifications :

Minimum Degree Required :

Master Degree

Minimum Years of Experience :

5 year(s)

Preferred Qualifications :

Preferred Fields of Study :

Biochemistry, Biomedical Engineering, Biology, Cell Biology, Chemical Engineering, Chemistry, Environmental Health/Engineering, Medicine/Health, Molecular Biology, Pharmacology

Preferred Knowledge/Skills :

Demonstrates thorough abilities and/or a proven record of success in conducting clinical trials including:

  • Performing clinical study management, clinical operations (site level) and execution of clinical trial visits, clinical trial planning, clinical assessment/ activities management, human subjects recruitment and retention, clinical supplies management, (IP, biological samples, study kits, etc.) IRB submissions and regulatory guidelines, (ICH, GCP, 21 CFR) usage and understanding of common technologies leveraged for clinical trials, (e.g. EMR, EDC, eCOA, TMF) oversight/management of protocol/study execution teams; and,

  • Working knowledge of drug development process, clinical trials (Phase I-IV), ICH GCP guidelines and application, virtual data collection technologies (eConsent, eCOA, web applications, patient portals, wearables, telehealth), study start-up activities.

Demonstrates thorough abilities and/or a proven record of success in Decentralized Clinical Trials, preferably obtained through one or more of the following:

  • Academic coursework or academic scientific research;

  • Direct work in the industry defined as one or more of the following:

  • Contract service organizations to the industry (e.g. CRO), CRA Study Manager, Study Monitor, Site Monitor;

  • Academic Centers as a Research Coordinator, Study Coordinator, Clinical Trial Specialist, Research Administrator, IRB Specialist, Research Nurse/ Study Nurse, Clinical Research Operations Specialist; and/or,

  • Biopharma/Biotechnology Study Manager, Assistant Study Manager, Site Manager, DCT Specialist, eCOA Specialist (business).

Demonstrates knowledge of the following and/or has real world data/evidence:

  • Drug development process;

  • Clinical Trials (Phase I-IV), ICH GCP guidelines and application;

  • Virtual data collection technologies (eConsent, eCOA, web applications, patient portals, wearables, telehealth);

  • Site level Clinical Operations and operating models; and,

  • Experience in clinical trials and the ability or desire to transition to consulting.

Demonstrates abilities and/or a proven record of success as a team member on project teams, including the following areas:

  • Understanding personal and team roles and contributing to a positive works environment by building relationships with team members; proactively seeking guidance, clarification and feedback;

  • Identifying and addressing research needs in a timely manner; delivering clear requests for information to inform the conduct of analysis or model development; demonstrating flexibility in prioritizing and completing multiple competing tasks, and communicating potential conflicts to a supervisor; and,

  • Researching and analyzing pertinent trial, industry, and technical matters; utilizing problem-solving skills; and, communicating effectively in written and verbal formats to various audiences (including various levels of management and external clients) in a professional business environment.

For positions in Colorado, visit the following link for information related to Colorado's Equal Pay for Equal Work Act: https://pwc.to/coloradoadvisoryseniorassociate .

All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.

PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy

For positions based in San Francisco, consideration of qualified candidates with arrest and conviction records will be in a manner consistent with the San Francisco Fair Chance Ordinance.

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Please note that, at this time, to be in-person at a PwC office, client location or PwC-sponsored events, you must be fully vaccinated against COVID-19.

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