Clinical Project Manager
Gabriel at AL Solutions is searching for a Clinical Project Manager to work for a small Biotech company that focus within Rare/Orphan Diseases and Oncology. Our client has an outstanding pipeline and portfolio with new products aiming to hit the market in 2021. The position can be worked remotely (as the company is remote during COVID-19) but ideally, we are looking for someone local to Baltimore. This would ideally be part-office based.
The Clinical Project Manager will report directly into the Associate Director of Clinical Operations and support the department in the planning and management of overall clinical operations execution – including timelines, budgets, resources, vendors, and key project deliverables in compliance with SOPs and regulatory requirements.
- Clinical operations support to achieve all deliverables from the clinical protocol to the clinical study reports
- Review study level Clin Ops Plans
- Develop outsourcing specs for vendor requests for proposal and scope of work agreements
- Manage external vendors
- Participate in review of data management deliverables from external vendors and CROs
- Assist in the planning and conduct of investigator meetings
- Provide input into non-project related activities and development of procedures
- Provide or facilitate training to clinical study teams on protocol specific reports
- Participate in external and internal meetings
- 6+ years’ experience within the Pharma/Biotech industry in human drug development
- Experience managing projects and/or matrix teams within Clinical Operations
- Rare Disease / Orphan Disease experience (ideal)
- 3 years’ + clinical trial management experience
- Understanding of ICH/GCP guidelines
- Interpersonal and negotiating skills
- Leadership, communication, and management skills
- Strong presentation skills
- Willingness to travel (pre COVID <15%)
AL Solutions are a niche Life Science agency that support a variety of Pharma, Biotech, and CRO companies across Europe & the USA. If you would like to apply, please click below, alternatively find a list of other opportunities on our website.