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Generate:BiomedicinesSenior Clinical Trial Manager
Generate:Biomedicines is hiring a remote Senior Clinical Trial Manager to support late-stage clinical trial execution for the company's chronic obstructive pulmonary disease (COPD) program. Reporting directly…
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About This Role
Generate:Biomedicines is hiring a remote Senior Clinical Trial Manager to support late-stage clinical trial execution for the company's chronic obstructive pulmonary disease (COPD) program. Reporting directly to the Director of Clinical Operations, this full-time position collaborates extensively with preclinical development, data management, clinical supply, and regulatory affairs teams. Founded in 2018, the employer is a clinical-stage generative biology enterprise utilizing machine learning and high-throughput experimentation to design protein therapeutics and…
Job Description
Generate:Biomedicines is hiring a remote Senior Clinical Trial Manager to support late-stage clinical trial execution for the company's chronic obstructive pulmonary disease (COPD) program. Reporting directly to the Director of Clinical Operations, this full-time position collaborates extensively with preclinical development, data management, clinical supply, and regulatory affairs teams. Founded in 2018, the employer is a clinical-stage generative biology enterprise utilizing machine learning and high-throughput experimentation to design protein therapeutics and transform drug development.
The chosen professional will independently coordinate operational activities for clinical trials, oversee external vendors, manage study budgets and schedules, and guide junior staff members. Ideal applicants are self-directed, detail-oriented communicators capable of thriving in a fast-paced setting while collaborating cross-functionally and maintaining trial inspection readiness.
Responsibilities
- Manage operational workflows for clinical trials and vendors including contract research organizations, central labs, and study sites
- Direct cross-functional internal study team meetings and oversee key deliverables
- Identify, qualify, and select clinical study sites and investigators in coordination with CRO partners
- Supervise day-to-day trial execution, covering site startup, participant enrollment, compliance, and data metrics
- Organize investigator meetings, kick-off events, and monitoring training sessions
- Create and evaluate study documents such as operations manuals, informed consent forms, guidelines, and training materials
- Contribute to the drafting of protocols, amendments, case report forms, ethics applications, and recruitment documents
- Control clinical study budgets and ensure alignment with project schedules and organizational objectives
- Lead monitoring oversight visits and collaborate with investigators and site personnel regarding outcomes
- Examine metrics and reports to guarantee timely accumulation of clinical data, biological samples, and lab results
- Partner on standard operating procedure creation and standardize clinical business tools
- Design corrective action plans for protocol compliance, safety, and administrative hurdles at sites and CROs
- Maintain and oversee the Trial Master File for assigned studies to ensure inspection readiness
- Participate in creating data presentations for scientific gatherings, management reviews, and advisory boards
- Train and mentor junior team members
Requirements
- Bachelor’s degree
- At least 8 years of clinical operations experience
- Minimum of 4 years of experience managing late-stage trial operations with a sponsor company
- Background in oversight of CROs, vendors, and laboratories
- Ability to travel domestically and internationally up to 30 percent of the time
- Comprehensive understanding of Good Clinical Practice
Qualifications
- Advanced scientific degree
- Experience across various therapeutic areas, with respiratory indications considered a strong plus
- Familiarity with global regulatory requirements such as FDA, EMA, and MHRA
Core Skills
Benefits
- Annual bonus
- Equity compensation
- Competitive benefits package
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, the source posting explicitly indicates that this role is remote, though it requires the ability to travel domestically and internationally up to 30 percent of the time.
What is the salary range for this role?
The annual base salary ranges from USD 140,000 to 196,000, with actual pay determined by factors like experience, job-related skills, education, and market dynamics.
What education and experience are required?
Candidates must have a bachelor's degree alongside at least 8 years of clinical operations experience, including a minimum of 4 years working in late-stage trial operations with a sponsor company.
What additional compensation is included beyond the base salary?
Employees in this role are eligible for an annual bonus, equity compensation, and a competitive benefits package.
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