Join our team

Associate Director/Director of Clinical Operations

Primary Responsibilities:

• Serve as primary point of contact for CROs conducting clinical studies, and other supporting external vendors;
• Review, evaluate, and advise on budget for CRO activities to identify and implement cost-saving changes in scope and allocation of responsibilities;
• Manage study budget on an ongoing basis;
• Lead coordination across external vendors including but not limited to: primary CRO, imaging and central overread vendors, regulatory affairs, QA personnel, and shipping and logistics vendors;
• Coordinate and monitor recruitment at and across sites;
• Oversee data collection and management;
• Support data safety committee (DRC) meeting logistics as needed;
• Interface with site investigators and other site personnel as needed;
• Assist in preparation for auditing, DUSR and annual reports, and other legal and regulatory filings.
• Author and implement vendor oversight SoPs
• Participate in internal and external conference calls;

Job Requirements:

• BS/MS in a scientific field of study with 10+ years of relevant experience working in Clinical Operations in the pharmaceutical/biotech industry or a CRO;
• Clinical trial experience in cardiovascular disease and/or oncology preferred;
• In-depth understanding of industry standards and applicable guidelines; FDA regulations and ICH GCP knowledge;
• Experience in developing clinical operations SOPs and metrics;
• Cross-collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics/Data Management, Finance and Program Leadership;
• Proven leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environment;
• Strong collaboration and team-working, communication and organizational skills required;
• Strong problem solving and analytical skills necessary;
• Ability to prioritize activities appropriately and manage time
• Willing to travel domestically and internationally as needed.