We are seeking a highly motivated and enthusiastic Manager / Sr. Manager of Clinical Operations with hands on expertise in taking novel oncology compounds from first in human through to completion of phase 2 clinical trials. The Manager/ Sr. Manager of Clinical Operations will be responsible for overseeing day-to-day study operations of one or more clinical studies to meet individual clinical trial objectives and corporate goals. For clinical studies assigned, this individual is responsible for all aspects of global and domestic clinical trials to ensure delivery of company goals on time, within budget, and in compliance with SOPs and FDA and ICH/GCP guidelines
Responsibilities and Duties
· Represents and leads the study team to ensure successful clinical trial planning, design, execution and delivery within specified quality, time and cost parameters.
· Demonstrates an extensive knowledge of clinical operations methodologies, organizational, project management, and leadership capabilities as well as strategic insight, decisiveness and strong judgment.
· Ensures a consistent, standardized approach to operational activities and clinical project management. Champions continuous quality improvement by evaluating methods and approaches and recommending efficient and/or novel approaches.
· Oversight of Contract Research Organization (CRO) and other clinical vendor activities to ensure the quality meets Marengo and regulatory requirements.
· Ensures oversight plan is developed and implemented, and continuously assesses operational performance through carefully designed performance (KPIs) and quality indicators.
· Effective management of issues and risks, and concise escalation and reporting to senior management, appropriate teams and collaborating functions.
· Establish (as part of a cross functional team) strong working relationships with internal functional leads (discovery and development) and external partners.
· Ensures timely and accurate information exchange and develop detailed understanding of other departments and functions and the associated interdependencies of those functions
· Accountable and responsible for compliance and quality management of clinical trials. Develops and adheres to relevant processes (SOPS) and work instructions.
· Maintains accurate documentation of trial progress through good documentation practices, storyboards and effective upkeep of trial master files (TMF) to sustain inspection readiness at all times.
· Participate in development and review of key documents for the support of clinical trial execution including protocols, oversight plans, case report forms, and other study management plans.
· Development and management of clinical trial financial agreements including study budgets, service contracts, and investigator grants.
· Leads the development and implementation of clinical operations SOPs and work instructions. Remains current in relevant product and professional areas of interest.
· Proactively identifies, negotiates, and brokers solutions to cross-study issues and identifies connections with other studies.
· Monitors the status of clinical data, including third party data, performing patient profiles reviews and protocol deviation tracking to enable timely lock of data bases, and familiarity with responsibilities associated with study close-out to published Clinical Study Report (CSR).
· Responsible for contributing to identification of sites, oversight of site performance and site management strategies in collaboration with CRO. Focuses on developing Marengo as a sponsor of choice. May perform periodic site/vendor visits to ensure compliance and maintenance of quality standards.
· Provides input and coordinates the delivery of clinical trial supplies in collaboration with Clinical Supply team.
· Represents clinical operations on various internal and external governance bodies (responsible for trial management), and provides periodic update of status of trial program, risks and mitigation plans to relevant stakeholders.
Qualifications and Skills
· BA/BS degree (advanced degree preferred) in life sciences or healthcare.
· 5 -10 years of relevant drug development experience, particularly in trial management and a minimum of 3 years in oncology clinical operations in a pharmaceutical company, biotech firm, or CRO. Demonstrated proficiency in management of multi-center regional clinical trials (MCRT) form initiation through close-out.
· Demonstrated project management experience and proven ability to work with minimal supervision in a cross-functional matrix environment. Experience in developing effective relationships with all relevant stakeholders.
· Thorough knowledge of GCP, clinical trial design, regulatory processes, and global clinical development process and a strong understanding of clinical compliance and inspection readiness