Manager, Clinical Monitoring

Akebia Therapeutics•Cambridge, MA

1d•Hybrid

About The Position

Please note: This position is currently based in our Cambridge, MA office. Please note that our offices will be relocating to Waltham, MA later this year, and this role will transition accordingly. We follow a flexible, “magnet not mandate” approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs. Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary We are seeking a Clinical Monitoring Manager to support the management of contract CRAs and the management of clinical study site activities for Akebia sponsored clinical trials. This role will also support the study team in various trial related activities. In this role, you will serve as a point of contact for the CRAs and CRO clinical monitoring team (where applicable) and liaise with clinical study sites and contribute to building a culture of team, site and patient centricity. This role is accountable for oversight of clinical monitoring activities from site identification through close out of the study site. The Clinical Monitoring Manager has ‘in-house’ responsibilities (e.g., CRA management), and as required by project scope, sponsor monitoring or co-monitoring visits at the clinical study sites. The Clinical Monitoring Manager reports into the AD, Clinical Monitoring and collaborates closely with the Clinical Study Lead, assists in the planning/management/execution of Akebia sponsored clinical trials, and contributes to the overall success of the clinical study according to company and department objectives.

Requirements

Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas (advanced degrees desirable)
8+ years of industry experience in clinical research operations
5+ years of experience as a CRA.
2+ years of experience leading a team of CRAs
Experience in study management/monitoring in multiple therapeutic areas
Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP), and FDA regulations
Experience with risk-based quality management and risk-based monitoring implementation including recent experience working on trials utilizing risk-based monitoring models.
Knowledge of regulatory guidances, requirements, and industry standard practices as pertaining to clinical monitoring practices and clinical study conduct.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
Strong understanding of clinical trial processes and study conduct
Excellent organizational and time management skills
Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
Experience working in a fast-paced and dynamic environment
Ability to communicate effectively with external health care providers and service providers, and Akebia cross-functional team members. Ability to facilitate discussions and share knowledge across multiple study teams, functional lines, and management levels.
Able to influence without authority.
Position may require up to 35% travel, including mandatory in-person attendance at all-hands meetings twice a year.

Nice To Haves

Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials a plus
Certification as a Clinical Research Associate (CCRA) or equivalent preferred

Responsibilities

Primary responsibility for the implementation and management of monitoring activities for assigned clinical studies to ensure timely, quality data in alignment with the global needs of the Clinical Development team and industry clinical data standards.
Draft and/or provide review of vendor monitoring plans and ensure compliance with Akebia’s standards. Oversee monitoring activities during the course of the clinical study and ensure compliance to the monitoring plan(s).
Review monitoring visit reports, monitor visit scheduling, report completion metrics, protocol deviations, issues and action items to identify site- and study-level issues.
Proactively identify, prevent, and mitigate monitoring risks. Manage/resolve site and/or monitoring issues including retraining, issue escalation, and implementation of corrective actions to prevent recurrence.
Perform monitoring/ monitoring oversight visits as required either independently or manage CRAs in the conduct of monitoring oversight visits to assess CRO performance. Prepare templates for visit reports and associated correspondence. Work cross-functionally to develop and execute action plans to address findings.
Oversee development and implementation of project specific processes, tools, and documents (e.g., monitoring oversight plans, site visit report templates, monitoring tools)
Support the training and development of in-house CRAs and ensuring study training compliance is maintained
Develop/review training materials and study tools for site and CRA use.
May act as line manager for CRAs directly or through a functional service provider, ensuring resources meet qualifications and performance expectations.
Provide input into the development and implementation of clinical monitoring SOPs.
Build relationships cross-functionally and with CROs/vendor support of the mission and goals for the monitoring function.
Drive improvements and innovation to enhance the quality of monitoring/ monitoring oversight activities; collaborate with clinical development and data management to define risk-based and remote monitoring approaches.
Support a culture of continual improvement and innovation; promote knowledge sharing.