Location: Cambridge MA
We are seeking a highly motivated and enthusiastic clinical operations professional local to Cambridge MA with hands on expertise in taking novel oncology compounds from first in human through to completion of phase 2 clinical trials. This will support H3 Biomedicine’s continued effort to identify unique anti-cancer compounds for the treatment of targeted patient populations. The Manager/Sr. Manager Clinical Operations, will be responsible for orchestrating clinical operations activities across a compound under development, and managing day-to-day study operations for one or more clinical studies to meet individual clinical trial objectives and corporate goals. For clinical studies assigned, this individual is responsible for overseeing all aspects of global and domestic clinical trials predominantly run through Contract Research Organizations to ensure delivery of company goals on time, within budget, and in compliance with SOPs and FDA and ICH/GCP guidelines
Principal Duties and Responsibilities
- 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, deciseveness and strong judgment.
- Ensures a consistent, standardized approach to operational activities and clinical project management. Champions continuous qualty improvement by evaluating methods and approaches and recommending effficient and/or novel approaches.
- Oversight of Contract Research Organization (CRO) and other clinical vendor activities to ensure the quality meets H3 Biomedicine and regulatory requirements. Ensures oversight plan is developed and implemented, and continuously assesses operational performance through carefully designed performance 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 and maintains accurate documentation of trial progress throgh dood documentation practices and effective upkeep of trial master files (TMF).
- 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 professionalareas of interest. Oversees and directs activities of Clinical Trial Associates.
- 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 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 H3 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.
- Ability to coach and mentor junior staff on industry best practices and GCP requirements
- 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
- local to Cambridge MA
About H3 Biomedicine Inc.
H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.