Position Description

Clinical Systems Analyst
Location Lexington, MA
Employment duration Full time
ID 1099
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​We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you’re looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.

The role:

We are seeking an experienced and detail-oriented Clinical Systems Analyst to join our team, focusing on EDC study builds, edit check programming, user access management, lab management and adhoc programming. This role will lead the development of eCRFs and data edit check programming under tight timelines, ensuring adherence to SOPs, guidelines, and quality standards. The ideal candidate will have a strong technical background in data management, with expertise in visualization tools such as SAS, R, and Python, as well as experience in Veeva EDC.

 

In the role you will:

  • Responsible for Study Builds in EDC and edit check programming.
  • Responsible for user access management for EDC.
  • Responsible for Lab management activities for Clinical studies.
  • Create/oversee the development of data edit check specifications and manual data listings, as required.
  • Review eCRF specifications and provide feedback on study database design.
  • Lead EDC study database design review meetings in a cross-functional team environment.
  • Manage clinical trial data or data management projects under aggressive timelines with high quality and in a professional manner, all while adhering to SOPs and work guidelines.
  • Responsible for adhering to Data Management timelines and budgets.
  • Responsible for generation of adhoc reports and listings using a variety of reporting and visualization tools.
  • Review and provide feedback on study protocols and cross functional study documents e.g., Clinical Monitoring Plans, Statistical Analysis Plans, etc.
  • Develop and review clinical data management functional processes, SOPs, and working instructions. 
  • Responsible for EDC system validation activities.
  • Cooperate and assist the Quality Systems department with quality control audits on assigned Clinical study databases.

Qualifications: About you

  • Bachelor or Master’s degree in Science, Healthcare, or related field
  • Minimum 3-5 years of technical or programming experience within Biopharma/CRO environment.
  • Oncology/Immuno-Oncology experience is preferred
  • Proficient working knowledge of any of the following strongly desired: SAS, R, Python, Spotfire, Cluepoints or other Visualization Tools, Data standards (CDASH and CDISC SDTM)
  • Prior study database design experience in Veeva EDC.
  • Solid technical skills and fast learning ability on new technologies and applications.
  • Overall understanding of ICH, GCP and other applicable regulatory guidelines as they pertain to clinical data management.
  • Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a study team environment effectively works with colleagues in medical, clinical science, medical writing, clinical operation, programming, and statistics.

#LI-JW1

Read more about our pipeline and visit us on LinkedIn

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

  • Highly competitive and inclusive medical, dental and vision coverage options (US & UK)
  • Flexible Spending Accounts for medical expenses and dependent care expenses (US)
  • Flexible Vacation Plan (US & UK)-In a time when we move at the speed of light, what matters most is what we achieve, not how many hours we clock or accrue. We want people to take breaks when they need them most and own their time. Our philosophy at Agenus is that freedom to take this time will lead to clarity, creativity and innovation through rested and refreshed eyes. With our Flexible Vacation Plan, Agenus will not limit the amount of vacation you can take. It will allow you to take the vacation time as you need, while fulfilling your job responsibilities and making meaningful contributions to our mission.
  • Care.com Memberships (US)
  • Education Assistance Program (US & UK)
  • 401k match (US) and Financial Planning tools, Private Pension (UK)
  • Employee Stock Purchase Plans (US &UK)
  • Employee Assistance Program (US &UK)
  • Reward & Recognition Program (US & UK)
  • Catered Lunch (site dependent)
  • Onsite Yoga (UK)
  • Free Parking (US & UK)

 

Our core values

The way we work sets Agenus apart.

We put the patient first.

We aspire to change the world, improving the experience and options available for every single cancer patient. The answers are out there, and patients are waiting.

We are bold, and we are one.

We believe that the only way to deliver on our goals is to aim high and work as one global team. We look for opportunities to challenge, collaborate with, and support one another. We aim to break conventional standards and perform at extraordinary levels.

We work with integrity, respect and honesty.

These three building blocks serve as pillars for how we behave, operate, and execute our mission.

We are a culture of ownership and accountability.

We hold ourselves accountable not only for exceptional results, but how we get our results.

We are obsessively curious and deeply committed to learning.

We live in a fast-paced environment that requires us to learn at or above the speed of change. We believe that curiosity fuels the desire to create, and learning provides the tools to progress.

We perform at our best every day.

Every day counts. We confront insurmountable obstacles, problems and choices with intellect, perseverance and hard work.

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