Clinical Trial Manager # 3745

Responsibilities will include but are not limited to:

• Managing all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out
• Preparing and review study related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms with minimal supervision
• Participating in identifying, selecting, and monitoring the performance of clinical sites
• Ensuring proper site training and management, provides ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all applicable regulations
• Participating in EDC set-up by contributing to case report form design, user acceptance testing, completion guideline development and other related activitiesIdentifies any potential risks to the study timelines and/or conduct, proposes mitigations and implements mitigations with cross-functional team and manager support
• Monitoring clinical data entry progress and follows up on incomplete data entry and/or outstanding queries
• Contributing to the development and management of site budgets and ensures invoice payment according to site payment terms
• Working cross functionally with other departments such as Legal, Clinical Data Management, Bio-specimen Management, Finance, Clinical Compliance, Clinical Development, and Lab Operations on all aspects of the clinical trial
• Providing oversight of regional study monitors and/or contract research organizations (CRO)
• Facilitating external communication with site staff and pharmaceutical partners (as applicable). 
• Ensuring Trial Master File (TMF) is current and maintained
• Providing guidance and mentorship to CPAs (Clinical Project Assistants)

Preferred Qualifications:

• Bachelor’s degree or equivalent in the life sciences or related field is required.
• Additional coursework in clinical trial planning and execution is strongly desired
• Ideal candidate will have 5 + years of relevant experience in managing clinical trials at a sponsor company (pharma, biotech, or medical device) with a strong track record of successful trial initiation and execution
• Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable
• Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements
• Working experience with an electronic data capture system, CTMS system, and eTMF system.
• Experience working on Investigational Device Exemption (IDE) and Real World Evidence (RWE) studies (highly preferred)
• Strong interpersonal communication (written and verbal), organizational and prioritization skills
• Able to work effectively under a fast-paced and changing environment
• Strong work ethic and demonstrated ability to deliver assignments on time
• Proficient with office automation tools, such as Microsoft Office and the Google suite of apps