Clinical Trial Manager

Benefits

Qualifications

• •5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
• •Prior phase II and III experience required
• •A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• •Experience with budget forecasting and management
• •Experience with clinical studies in oncology
• •Ability to travel internationally to visit clinical sites and for study meetings
• •Proven proficiency in overseeing large complex studies being managed in house and by a CRO
• •Demonstrated ability to lead teams and work in a fast-paced team environment
• •Experienced and enjoys building relationships with KOLs and site personnel
• •Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues
• •Demonstrated ability to build and deliver on patient enrollment strategies
• •Excellent interpersonal and decision-making skills
• •Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
• •Demonstrated ability to comprehend complex scientific concepts and data
• •Proficient in reviewing and assessing clinical data
• •Possesses excellent planning, time management & coordination skills
• •Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• •Experience in working in a small organization
• •Excellent written and oral communication skills
• •16 more items(s)

Responsibilities

• •HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI
• •HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC
• •HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC
• •HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy
• •The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies
• •Responsible for study start up and maintenance through study close out
• •Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies
• •Responsible for all performance metrics and quality of deliverables in the clinical trial
• •Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met
• •Initiates and builds solid professional relationships with key opinion leaders and clinical site staff
• •Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time
• •Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
• •Proactive identification and management of study related risks
• •Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
• •Responsible for reviewing and managing study related plans, processes including
• •Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring
• •Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met
• •Reviews and approves essential document packages to enable timely site activations
• •Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
• •Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
• •Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• •Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
• •Perform periodic QC of the TMF
• •Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices
• •Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
• •Ensures the study is "inspection ready" always
• •Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project
• •All other duties as assigned
• •Amount will vary upon project needs (up to 20%)
• •26 more items(s)