Director, Clinical Operations
Back to JobsApply Now
Clinical Operations Manager
An expanding company in Rockville, MD is looking for a Director to oversee clinical operations, vendor relationships, site management, and contract negotiations.
Responsibilities:
· Supervise and develop a clinical team while participating in the creation and writing of clinical trial protocols.
· Lead the identification and selection of clinical sites, manage trial agreements, and handle budget discussions.
· Identify, onboard, and oversee external partners such as CROs, central IRBs, and clinical labs.
· Manage vendor contracts and budgets throughout the entire clinical trial process.
· Forecast investigational product needs and manage inventory.
· Review and approve clinical study documents including SAPs, EDC design, validation, study reports, and more.
Qualifications:
· Bachelor's degree and 12+ years of experience in clinical operations, with expertise in vendor management and budget oversight.
· 4+ years experience in a services organization, preferably in pharmaceuticals, biotechnology, or contract research.
· 6+ years of team leadership experience and handling complex projects.
· Experience with IND and NDA submissions.
· Strong analytical and critical thinking skills, with sound judgment in fast-paced environments.
· Demonstrated leadership abilities with a coaching mindset and collaborative approach.
· Skilled in building professional relationships and communicating effectively with all levels of an organization.
· Exceptional written and verbal communication skills for engaging with teams and stakeholders.
Leave a Reply
You must be logged in to post a comment.