Clinical Operations Manager

• Rockville, MDAn 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.