Associate Director, Clinical Operations

Role Summary

The Associate Director, Clinical Operations is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. This position is responsible for study start up and maintenance through study close out. The Associate Director, Clinical Operations will coordinate, lead and drive Summit’s cross functional team members, CROs, and vendors to successfully deliver clinical studies. They will be responsible for all performance metrics and quality of deliverables in the clinical trial.

Responsibilities

• Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO, and vendors to ensure that overall project objectives are met
• Fosters solid professional relationships with key opinion leaders and clinical site staff
• Partners with CRO(s) to ensure robust patient enrollment strategies are developed and carried out effectively and on time
• Partners with CRO(s) 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, and safety monitoring
• Reviews CRO(s) 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 (GCP)
• 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 ‚Äúinspection ready‚Äù always
• Responsible for oversight and coaching of the functional activities of Clinical Research Associates and Clinical Trial Associates allocated to the project
• All other duties as assigned

Qualifications

• Bachelor‚Äôs degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
• 10+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
• A minimum of 5+ years of phase II and III combined experience required
• Strong 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 strongly preferred
• Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
• 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
• Line management (direct reports) experience is preferred
• Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities
• Proven track record of 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 and communicate 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
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
• Strong attention to detail, accuracy and confidentiality
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents

Education

• Not specified beyond degree requirements in the qualifications above