Senior Clinical Trial Manager
- Company
- Albion Rye Associates
- Location
- Philadelphia, Pennsylvania (US)
- Salary
- $140,000 - $160,000 + bonus, competitive 401k and other benefits
- Posted
- Jul 18, 2022
- Closes
- Aug 17, 2022
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Albion Rye Associates are looking for an experienced clinical trial manager to support our client based in the US, across the Tri State Area. The ideal candidate will have 5 + years in clinical drug development at a managerial level. Experienced in managing global clients, and experience in the Pulmonary, Hepatology or Fibrosis.
The candidate will be responsible for the execution of clinical trials, create and drive solutions across a multi-functional team. Reporting directly to the VP of Clinical Operation
Key Responsibilities:
- Anticipate and resolve complex, key technical, operational problems with team.
- Use of performance metrics
- Support authority inspections, CQA audits and audit readiness
- Lead, collaborate and review study documents
- Ensure management of TMF set-up
- Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications
- Knowledge of ICH/GCP and regulatory guidelines/directives.
- Review line listings, write and resolve queries, review protocol deviations, and prepare for interim/final Clinical Study Reports.
- Mentoring & management of multi-functional team
Experience:
- BA/BS degree in a relevant discipline with 5+ years’ experience in clinical drug development required at Clinical Trial Manager level.
- Pulmonary, or hepatology and or fibrosis experience preferred.
- Experience in managing global clinical trials preferred.
- Experience leading a team and managing day to day operations
- Must Live in the US and have the right to work
- Experience in Pulmonary, Hepatology or Fibrosis and respiratory
If you feel this is for you get in contact ASAP as they are looking to move quickly on it. You can email me at Charlie.tyzack@albionryeassociates.com or give a call on +1 857 930 7549