Celcuity

Compensation

Full Description

Job Description: • Responsible for timelines and quality of CDM deliverables for the assigned studies • Contributes to technical infrastructure of CDM such as not but limited to development of SOPs, departmental process improvement etc. • Ensures Data Management Plans are followed through the course of the studies • Provides feedback and task assignment to meet department and company objectives • Supports budget and resource planning across assigned projects as required • Participates in CRO/vendor selection process for outsourced activities • Directs activities of direct reports as applicable • Participates in department or cross-functional initiatives as appropriate • Represents CDM in study team meetings • Manages or establishes CDM timelines to synchronize deliverables with the overall study timelines • Proven ability to perform detailed hands-on work as well as high-level strategic task • Generates and/or reviews/approves study documents (e.g. study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, coding conventions) • Oversight of CDM CRO/service providers (e.g. reviewing vendor SOPs, invoices) • Monitors the progress of all CDM activities for the project to ensure project timelines are met • Responsible for the accuracy and completeness of the clinical data collected during a clinical trial • Performs duties as assigned by CDM management/Head of Department. Requirements: • Bachelor’s, or master’s degree (preferred) in Life Sciences, Computer Sciences, Mathematics, or health-related field • Minimum ten (10) years of DM experience in the pharmaceutical or biotechnology industry • Three (3) year of staff management desired • Demonstrated ability to pay attention to details and superior organizational skills • CRO management experience • In-depth knowledge of CDM principles, clinical trial process and regulatory requirements • Good working knowledge of ICH, FDA, and GCP regulations and guidelines • Proven ability to work both independently and in a team setting • Experience with web-based Electronic Data Capture (EDC) preferably Medidata Rave, clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug • Prior oncology/hematology experience highly desirable • Outstanding organizational skills with the ability to prioritize • Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment • Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization • Flexible and willing to learn; adapting to business and site needs in a dynamic environment • Maintain a positive, approachable and professional attitude. Benefits: • medical, dental, vision insurance • 401(k) match • PTO • paid holidays • annual performance incentive bonus • new hire equity package