Senior Clinical Trial Manager/Associate Director Clinical Operations

Senior Clinical Trial Manager / Associate Director Clinical Operations (West Coast Based) This range is provided by Thorough Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range $130,000.00 / yr - $190,000.00 / yrOur client is a fast-growing biotech company focused on developing breakthrough therapies in Oncology. Join a team that thrives on collaboration, innovative thinking, and scientific expertise to drive their clinical programs forward. The Senior CTM / AD will be responsible for the successful execution of outsourced clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables, typically working on studies with moderate to high complexity (in terms of design, location, phase, etc.), and proactively identifying and resolving clinical project issues while participating in process improvement initiatives as required.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.Manages all clinical aspects of study including : assesses operational feasibility and recommends study execution plan; manages comprehensive study timelines and metrics; participates in selection and management / oversight of external vendors; reviews vendor reports, budgets, and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites, and other contract personnel; prepares and presents project debriefings, as required; plans, executes, and leads study-specific meetings; participates in site monitoring visits as appropriate.Uses operational and therapeutic expertise to optimize trial execution : prepares study-related documentation; provides input for the design of the ICF template, CRFs, monitoring conventions, edit checks, etc.Prepares and / or reviews study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, and CRF Completion Guidelines)Prepares / reviews site study documents (i.e., site-specific informed consent, study tools / worksheets, investigator contracts, and site payments).Ensures all clinical trials are executed in compliance with international GCP guidelines / regulations and SOPs : ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate.Daily interactions with members of the cross-functional study team; leads the Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.).Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management; strong clinical study management skills. Also requires excellent communication and organizational skills, along with problem solving, conflict resolution, leadership, and team-building skills.Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations.EDUCATION, EXPERIENCE AND / OR SKILLS REQUIREDBachelor’s degree or equivalent combination of education / experience in science or health-related field required.Minimum of 7 years of clinical trial experience in Pharmaceutical, Biotech, or CRO company required, with a minimum of 4 years of trial management experience.Global Clinical Trial Experience specifically in US and Europe.Knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.Comfortable operating in a fast-paced, dynamic, small company environment with minimal direction. Able to adjust workload based upon changing priorities.Strong interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.Proven ability to work independently and under constant deadlines; able to work in a quickly changing, not fully structured internal and external environment.Demonstrated ability to appropriately handle highly sensitive and confidential information.Strong understanding and comprehension of medical terminology, with the ability to interpret and present scientific and clinical trial data.Able to travel domestically and internationally up to 20%, as per business needs.Excellent time management skills and attention to detail.Proficiency in Microsoft Word, PowerPoint, and Excel.Willingness to develop and utilize proficiency in Microsoft Project.Ability to comprehend and interpret medical information and clinical data.Willing to attend training opportunities, where deemed necessary by company leadership to better support medical writing or project management.Seniority level Mid-Senior levelEmployment type Full-timeJob function Management and Project ManagementIndustries Biotechnology Research and Pharmaceutical Manufacturing#J-18808-Ljbffr

Salary : $130,000 - $190,000