Remote opportunity at
Aixial GroupSenior Clinical Trial Manager - (CRO) Radiopharmaceutical experienced
Harvest Integrated Research Organization (HiRO) operates as a boutique, globally focused contract research organization connecting laboratory science with commercial pharmaceutical markets. The company seeks a Senior…
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About This Role
Harvest Integrated Research Organization (HiRO) operates as a boutique, globally focused contract research organization connecting laboratory science with commercial pharmaceutical markets. The company seeks a Senior Clinical Trial Manager with specialized experience in radiopharmaceuticals to join its team on a home-based, remote basis with occasional travel required. In this leadership role, the Senior Clinical Trial Manager will provide technical support, mentoring, and oversight to clinical monitoring teams, helping ensure adherence…
Job Description
Harvest Integrated Research Organization (HiRO) operates as a boutique, globally focused contract research organization connecting laboratory science with commercial pharmaceutical markets. The company seeks a Senior Clinical Trial Manager with specialized experience in radiopharmaceuticals to join its team on a home-based, remote basis with occasional travel required.
In this leadership role, the Senior Clinical Trial Manager will provide technical support, mentoring, and oversight to clinical monitoring teams, helping ensure adherence to quality standards and financial goals across international projects. This position suits an experienced clinical research professional adept at managing cross-border trials, oncology studies, and complex monitoring strategies while collaborating with clients and internal departments.
Responsibilities
- Allocate workload and site assignments among the clinical monitoring staff
- Monitor project deliverables, track progress using specialized tools, and potentially develop Clinical Management Plans
- Disseminate information efficiently throughout the clinical research associate team
- Communicate with clients and various internal departments regarding monitoring deliverables and activities
- Align clinical operations with established project budgets
- Review site communications and monitoring reports to identify quality issues, implement corrective action plans, and escalate findings
- Contribute to study material development and present at investigator or launch meetings
- Identify out-of-scope tasks and help complete monitoring aspects related to change orders
- Take part in business development proposals, proposal generation, and defense meetings
- Coach junior Clinical Trial Managers on functional delivery, risk evaluation, and action execution
- Evaluate staff competency through Performance Assessment Visits
- Contribute to study risk assessment plans and ensure team compliance with monitoring strategies and regulations
- Work alongside medical monitoring, safety, and quality assurance departments to prepare clinical scopes for inspections
Requirements
- Prior clinical research or monitoring experience
- Experience in a Clinical Trial Manager or Clinical Trial Lead role
- Direct radiopharmaceutical clinical trial experience
- Oncology experience
- Familiarity with Good Clinical Practice guidelines, ICH guidelines, and regulatory requirements
- Proficiency in Microsoft Office applications and computer literacy
- Ability to travel as needed
Qualifications
- Bachelor degree or Registered Nurse qualification in a related field, or an equivalent combination of education, training, and experience
Core Skills
Benefits
- Paid time off
- Medical, dental, and vision insurance
- 401(k) retirement plan for eligible employees
- Opportunities for accelerated career advancement
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 job is home-based and remote with occasional travel required.
What experience is required for this role?
Candidates must have prior clinical research or monitoring experience, including time in a Clinical Trial Manager or Clinical Trial Lead capacity. Direct radiopharmaceutical clinical trial experience and oncology experience are required.
What education is necessary?
A Bachelor degree or Registered Nurse qualification in a related field, or an equivalent combination of education, training, and experience is required.
What is the compensation for this position?
The specific salary is not stated in the job posting, though the compensation package is commensurate with experience.
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