Clinical Data Manager

| Greater NYC Area | Hybrid
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Clinical Data Manager 

Today, the biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $100M+. And the problem is only getting worse.

At TrialSpark, we don’t believe it has to be this way. Through technology and a new operational model, we’re reimagining how clinical trials are run, with the mission of bringing new treatments to patients faster.

We do this by partnering with physicians to enable them to run clinical trials within their existing practices. By providing the technology platform, equipment, and staffing, TrialSpark alleviates the operational burden of clinical research, enabling physicians to focus on what they do best -- patient care. And by bringing clinical research to physician practices, TrialSpark is enabling access for the 98% of patients who are never exposed to clinical trial opportunities.

About the role

The Clinical Data Manager (CDM) role is critical to the success of the studies TrialSpark is engaged in. The CDM oversees all facets of clinical data management of studies, from feasibility to closeout. They are responsible for ensuring that high-quality data is collected through design, validation and cleaning of the systems involved.

Core responsibilities:

  • Translate protocols into eCRF and eSource specifications
  • Write UAT test scripts for eCRF and eSource forms
  • Perform/execute User Acceptance Testing
  • Track database set-up, testing, maintenance and data entry metrics
  • Communicate with internal project teams and vendors on data management matters
  • Review study documents, design and develop project specific guidelines and instructions
  • Design eCRF, Data Management and Data Validation Plans and test EDC databases
  • Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
  • Code medical data
  • Track and report metrics leading to database lock
  • Coordinate the processing, dispatch and archiving of CRFs/queries
  • Maintain Clinical Data Management working files
  • Perform database QC checks, prepare and attend audits
  • Train internal project teams on CRF completion and data management topics
  • Serve as an SME for clinical data management activities

Experience/About you

  • College/University degree, or equivalent combination of experience and education
  • Prior experience with clinical data (3+ years minimum)
  • Experience with Clinical Data Management systems (Medidata Rave, Oracle InForm, ClinTrial, Medrio)
  • Working knowledge of CDISC, CDASH and SDTM
  • Ability to write test scripts for User Acceptance Testing (UAT)
  • Ability to conduct data review in accordance with the study protocol and DMP
  • Ensure compliance with regulatory requirements and GCP
  • Organizational and time management skills
  • Ability to work independently and multi-task

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status


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Technology we use

  • Engineering
  • Product
  • People Operations
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    • LookerAnalytics
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Location

Our office is located in Manhattan, near the Empire State Building. The area is lively and has great food and transportation options!

An Insider's view of Formation Bio

What’s the vibe like in the office?

The space is very open which makes it easy to collaborate and engage with different teams across the organization. People are very welcoming, supportive, and friendly. There is always a variety of different food and drinks available in the kitchen, in addition to foods that co-workers bring in for everyone to taste!

Joseph Frappaolo

IT Support Technician

What projects are you most excited about?

The project that excites me most is our new hire onboarding program because of the impact it will have on our company. Though we have a robust onboarding program in place already, we have the opportunity to think creatively about how to make the experience even better for our new hires, from the moment they accept our offer.

Erin Siegel

Senior People Operations Manager

How has your career grown since starting at the company?

I started working at Formation Bio in July of 2018. I joined the company as a Clinical Research Coordinator and was allowed to grow and adapt into new roles as the company's business model shifted. I transitioned into working as a Clinical Trial Associate after a couple of years, and now have over a year of experience as a Clinical Project Manager!

Gurpreet Singh

Clinical Project Manager

How has your career grown since starting at the company?

Formation Bio has given me the opportunity to take ownership over big projects and work streams, allowing me to have an impact on key functional business areas.

Maya Dongier

Senior Accounting Manager

What are Formation Bio Perks + Benefits

Formation Bio Benefits Overview

Formation Bio is nothing without its employees, so they are well taken care of! We offer comprehensive benefits that span from insurance to 401ks, with added perks like a pet-friendly office. Come meet our office dog, Rosie!

Culture
Open door policy
Open office floor plan
Employee resource groups
Hybrid work model
Flexible work schedule
Diversity
Mandated unconscious bias training
Diversity employee resource groups
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental insurance
Vision insurance
Health insurance
Life insurance
Financial & Retirement
401(K)
Company equity
Pay transparency
Child Care & Parental Leave Benefits
Generous parental leave
Vacation & Time Off Benefits
Unlimited vacation policy
Paid holidays
Paid sick days
Office Perks
Company-sponsored outings
Yearly retreat and holiday party, regular team events and outings!
Free snacks and drinks
Company-sponsored happy hours
Fitness stipend
Home-office stipend for remote employees
Mother's room
Professional Development Benefits
Job training & conferences
Lunch and learns
Promote from within
Continuing education stipend
Virtual coaching services

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