Research Associate III/Senior Research Associate – Data Collection – Peri- and Post-Approval Studies

at Evidera (view profile)
Location London, United Kingdom
Date Posted September 24, 2020
Other Locations UK; Sweden

Description

The Team

Evidera has been providing epidemiology, data analytics, and outcomes research services to clients in the biopharmaceutical industry for over 19 years. The Peri- and Post Approval Studies team supports pharmaceutical/ biotechnology/ medical device companies in the design and conduct of real-world observational studies throughout the product lifecycle, from early pre-launch planning to launch and post-marketing management. Our focus is on helping our clients identify evidence gaps and rapidly build epidemiologic and economic evidence to demonstrate the effectiveness, safety and value of their products. For this role, the focus is on de novo (field) data collection studies such as single and multi-country retrospective chart reviews, surveys, prospective studies, registries and post-market safety studies which are undertaken when existing health databases cannot be used. Increasingly, hybrid studies that invoke the use of both secondary data sources with bespoke data collection methods are deployed to address our clients’ needs.

Data collected in these studies is then used to address key research questions such as:

  • Burden of disease and identification of unmet needs
  • Treatment patterns, drug utilization, adherence
  • Resource utilization
  • The identification and impact of risk factors on disease outcomes
  • Comparative effectiveness
  • Safety outcomes

We use epidemiologic methods to build knowledge of the relationships between patient, drug, clinical and disease factors that significantly aids our clients and the patients they serve in understanding health conditions and navigating potential drug-event causal relationships as well as in building stronger evidence-based value messages.

Position Overview

The Research Associate III/SRA in Data Collection drafts project deliverables, interacts with clients, and contributes to strategic thinking under the direction of senior staff. Supports scientific coordination and project management, including scoping, tracking progress, and coordinating team tasks for multiple projects.

Principal Duties and Responsibilities (Essential Functions**):

The Research Associate III/SRA in Data Collection will bear scientific responsibility for the design and implementation of de novo data collection studies (retrospective, prospective, and/or cross-sectional) under oversight of more senior staff.

In particular, the Research Associate III/ SRA will:

  • Provide scientific guidance/consultation on scientific methodological and operational considerations of study design and conduct
  • Lead on or oversee the development of draft scientific project deliverables (e.g., protocols, analysis plans, case report forms (electronic or paper), survey questions, reports) for senior review.
  • Interact directly with study sponsors, physician experts, and clinical sites
  • Assist the responsible scientist with monitoring project budget spend and managing timelines for scientific tasks/deliverables.
  • Contributes to abstracts and manuscripts as co-author.
  • Contribute to the growth of Evidera through business development activities, including support of proposal development, participation in the sales cycle, conference attendance, and presentations
  • Support other organizational activities as needed (e.g. supervise and/or mentor junior staff; closely collaborate with other project stakeholders such as clinical operations, data management, biostatistics, and data analysts; contribute to development of training materials and process improvements)
  • Travel (national and international travel) is expected

Consulting Expectations:

  • Participates in client calls and is expected to be able to address questions posed directly to him/her about his/her work, otherwise participates minimally.
  • Contributes to strategic thinking under the direction of senior staff.

Managerial Duties: None

Education, Professional Skills & Experience

  • PhD (epidemiology/pharmacoepidemiology or closely related field) or MSc with relevant experience
  • Experience with de novo data collection (field) studies (non-interventional designs in particular)
  • Good understanding of epidemiologic study designs
  • Previous experience in consultancy and/or CRO environment highly desirable
  • Working knowledge of MS Office software; working knowledge of data analysis software (e.g., SAS, Stata, R) a plus
  • Demonstrated ability to communicate and document information effectively in written English, including the ability to produce scientific reports, presentations, emails and other written deliverables that are well-organized, free from errors, and are appropriately adjusted to the characteristics and needs of the audience.
  • Strong organizational, time-management, prioritization and decision-making skills necessary to evaluate, plan and accomplish multiple work goals in a timely fashion.
  • Able to quickly learn and apply new information, skills and procedures.
  • Proactive and positive approach to tasks and projects, as well as resilience when encountering process, project, budget or client changes that are inherent in the consulting environment.
  • Strong communication and interpersonal skills including the ability to quickly develop and sustain positive rapport with internal and external contacts in person, over the phone and by email.
  • Experience presenting ideas to individuals and groups in a formal presentation setting
  • Delivers a positive internal/external client experience; listens and understand the client's needs, and recommends solutions
  • Demonstrates sound professional judgment in analysing, responding to, and resolving enquiries, issues and escalations.
  • Experience with design of peri- or post-approval late phase interventional studies is not required but would be considered a plus

About Evidera:

Evidera is a business within in Pharmaceutical Product Development, LLC (PPD) a leading global contract research organization (CRO), and a is a preeminent provider of evidence-based solutions. We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.

Perks:

We offer a competitive salary and benefits package, with clear opportunities for growth and career progression. You will have the opportunity to work on multiple projects with some of the industry’s leading researchers. Our offices boast a fun and collaborative working environment, frequent social events and a robust support system. We are committed to providing training and professional development, with ample opportunity to advance, for all our staff.

Evidera’s Core Competencies:

  • Customer Focus
  • Initiative
  • Teamwork
  • Problem Solving/Judgment
  • Accountability

If you resonate with our core competencies and want to contribute to research and consulting services driven by world-class science and thought leadership, then please submit your application – we’d love to hear from you.

 

Evidera, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, sexual orientation, gender preference, disability, or status as a qualified individual with a disability or protected veteran. 

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