Senior Clinical Trial Manager - Phase II/III Operations

Absci Corp.

Northern (KY)

Hybrid

USD 90,000 - 150,000

Full time

14 days+
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Benefits offered by this job

Medical insurance
Dental insurance
Paid time off
401(k) with match

Job summary

Absci Corp. is seeking an experienced Clinical Trial Manager to independently lead end-to-end operational execution of global Phase II-III trials.

You will manage CROs, vendors, and internal teams to ensure quality, compliance, and efficiency throughout startup to closeout. You will develop study-level operational plans and oversee TMF quality, recruit and retain patients, and coordinate with legal and finance on contracts and budgets.

Qualifications

  • 5+ years of direct clinical trial management experience in pharma/biotech/CRO.
  • Familiar with GCP, FDA regulations and ICH guidelines.
  • Experience configuring and managing electronic patient-reported outcomes (eCOA) systems.
  • Knowledge of clinical trial regulatory filing requirements across major regions (US, EU, UK).
  • Willingness to travel up to 20% to oversee trials and attend meetings.

Responsibilities

  • Independently manage all operational aspects of Phase II-III trials from startup to closeout.
  • Oversee CROs and vendors to ensure alignment with timelines and regulatory standards.
  • Develop and maintain operational plans, monitoring, communication, and risk management.
  • Ensure robust patient recruitment and retention strategies with sites and CROs.
  • Collaborate with legal and finance to manage study budgets and contracts.

Skills

Clinical trial management
Regulatory compliance
CRO/vendor management
GCP compliance
Data analysis
Site monitoring
Team collaboration

Education

Bachelor's degree in life sciences or related
Advanced degree welcomed

Job description

Absci Corp. is seeking an experienced Clinical Trial Manager to independently lead end-to-end operational execution of global Phase II-III trials.

You will manage CROs, vendors, and internal teams to ensure quality, compliance, and efficiency throughout startup to closeout. You will develop study-level operational plans and oversee TMF quality, recruit and retain patients, and coordinate with legal and finance on contracts and budgets.

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