Senior Clinical Trial Manager (CTM)
Praxis Precision Medicines, Inc.
4 months ago
Remote friendly (United States)
United States
Clinical Research and Development
Primary Responsibilities:
- Manage study activities for successful execution of clinical trials from protocol concept through clinical study report, complying with Good Clinical Practice (GCP) and international regulations.
- Manage strategic engagement with key collaborators.
- Set up and oversee clinical trial trackers (regulatory documents, trial master file (TMF), startup progress, screening/enrollment, invoices/payments, project budgets, etc.).
- Contribute to IRB/EC and regulatory submissions.
- Oversee TMF reviews to ensure completeness and inspection readiness.
- Regularly review documents to ensure adherence to Clinical Operations and/or project-specific quality requirements (e.g., SOPs, work practices, training guides).
- Identify and mitigate study risks; escalate as necessary.
- Direct initiatives to identify and implement best practices and continuous improvement plans.
Qualifications & Education:
- Bachelor’s degree in a scientific field required; advanced scientific degree a plus.
- 5+ years directly managing clinical trials in a Sponsor or CRO setting.
- In-depth knowledge of clinical trial operations, ICH, GCP, and applicable regulatory requirements.
- Experience directing clinical operations team members.
- Experience working across multiple functional areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance).
Key Success Factors / Required Skills:
- Intellectual curiosity, innovation, and creative problem solving.
- Critical thinking in fast-paced projects; strong sense of urgency.
- Self-motivated with ability to work autonomously and collaboratively.
- Highly organized and detail-oriented; quality-focused.
- Strong verbal and written communication skills; relationship building.
- High professionalism, confidence, ethical standards.
Annualized Base Salary: $168,000 USD - $188,000 USD
- Manage study activities for successful execution of clinical trials from protocol concept through clinical study report, complying with Good Clinical Practice (GCP) and international regulations.
- Manage strategic engagement with key collaborators.
- Set up and oversee clinical trial trackers (regulatory documents, trial master file (TMF), startup progress, screening/enrollment, invoices/payments, project budgets, etc.).
- Contribute to IRB/EC and regulatory submissions.
- Oversee TMF reviews to ensure completeness and inspection readiness.
- Regularly review documents to ensure adherence to Clinical Operations and/or project-specific quality requirements (e.g., SOPs, work practices, training guides).
- Identify and mitigate study risks; escalate as necessary.
- Direct initiatives to identify and implement best practices and continuous improvement plans.
Qualifications & Education:
- Bachelor’s degree in a scientific field required; advanced scientific degree a plus.
- 5+ years directly managing clinical trials in a Sponsor or CRO setting.
- In-depth knowledge of clinical trial operations, ICH, GCP, and applicable regulatory requirements.
- Experience directing clinical operations team members.
- Experience working across multiple functional areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance).
Key Success Factors / Required Skills:
- Intellectual curiosity, innovation, and creative problem solving.
- Critical thinking in fast-paced projects; strong sense of urgency.
- Self-motivated with ability to work autonomously and collaboratively.
- Highly organized and detail-oriented; quality-focused.
- Strong verbal and written communication skills; relationship building.
- High professionalism, confidence, ethical standards.
Annualized Base Salary: $168,000 USD - $188,000 USD