Clinical Trial Manager (Contract) # 3293

You will:

• Manages all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out. 
• Prepares and reviews study related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms with minimal supervision.
• Participates in identifying, selecting, and monitoring the performance of clinical sites.
• Ensures 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.
• Participates in EDC set-up by contributing to case report form design, user acceptance testing, completion guideline development and other related activities.
• Identifies any potential risks to the study timelines and/or conduct, proposes mitigations and implements mitigations with cross-functional team and manager support.
• Monitors clinical data entry progress and follows up on incomplete data entry and/or outstanding queries.
• Contributes to the development and management of site budgets and ensures invoice payment according to site payment terms.
• Works cross functionally with other departments such as Legal, Data Management, Biospecimen Management, and Finance on all aspects of the clinical trial.
• Provides oversight of regional monitors, vendors or contract research organizations (CRO).
• Establishes and maintains strong relationships and communication with sites and site staff.
• Ensures Trial Master File (TMF) is current and maintained.
• Provides guidance and mentorship to CPAs (Clinical Project Assistants).

Your qualifications and background will include:

• Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework in clinical trial planning and execution is strongly desired.
• Ideal candidate will have at least 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.
• 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.