Location: Philadelphia, PA (Partial remote)
Type: Full Time, Salaried with benefits
Small Biotech Company is looking a Sr Clinical Trial Manager to join their team!
- Bachelor's Degree or equivalent combination of education/experience in science or health related field required
- 5-10 years of experience in the Biotech or Pharma Industry as a Clinical Study/Trial or Operations Manager or similar
- Cell and/or gene therapy experience required
- Theoretical and working knowledge of applicable GCP and ICH guidelines as well as basic understanding of the phases of clinical development, clinical monitoring and site management
- Strong interpersonal skills required; excellent written and oral communication skills
- Computer literacy in several software packages
- Driven, motivated - able to work in small team environment
- Successful execution of complex clinical trials from concept through study closeout
- Manage all clinical aspects of study, including assesses operational feasibility and recommends study execution plan, develop and manage timelines and metrics; site selection, management/oversight of external vendors, develop vendor specifications and provide study specific site trainings
- Plan, execute and lead study- specific meetings (Study Management Meetings, Investigator Meetings, Advisory Committee)
- Assist with protocol design, ongoing data review plans, preparation of study-related documentation, provide in put for design of CRFs, ICF template, monitoring conventions, etc.
- Assist with the development and management of study budget and maintains it with financial goals; reviews and approves invoices against approved budget
- Ensure clinical trials are executed in compliance with GCP guidelines/regulation's, ICH, and SOPs
- Participate in planning of QA activities and resolutions
- Daily interaction with Clinical Science/Medical Director and members of cross-functional study team; leading team as needed
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
About the Company
With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:
- Scientific staffing for hard-to-find skills
Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.
- Clinical lifecycle recruiting
From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.
- Equipment calibration, maintenance and validation
Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.
- National healthcare recruitment
Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search.