The Manager, Clinical Operations will be a highly visible role in Abiomed. The Manager, Clinical Operations will work closely with the leaders of the Medical Office and Clinical Research team responsible for executing Abiomed’s global clinical research strategy. This leader will be responsible for the operations of Abiomed’s clinical trials and registries and ensure these are conducted in accordance to Good Clinical Practice guidelines and FDA/EU regulations. The Manager, Clinical Operations will lead the identification and implementation of clinical trial support systems (i.e. Veeva Vault, CTMS, Payments), Vendor (AROs, CROs and Core Labs) alliance management and develop and mentor our contracts, communications and clinical training specialists team members.
Primary Duties and Responsibilities:
Manage and lead direct reports within clinical data management team, data/data system analysts and clinical training specialists with all aspects of their responsibilities.
Lead and develop alliance management practice for collaborations between Abiomed and its clinical trial partners
Support alliance governance forums and adjunct activity for agenda setting, scheduling and minutes
Procure and oversee outside vendors (i.e. CRO, ARO, Core Labs, Imaging) and consultants as required. In particular, leadership of large outside CROs including the use of the internal resources to provide specifications, scope of work, budgeting limits and execution direction.
Serves as the lead of Clinical Systems to securely gather, organize, and streamline trial information compiled as intended to facilitate shared accessibility and improved decision making by the study teams, CROs and other functions involved in the execution and management of clinical trials
Manages and oversee the study CTMS including digital integrations with eTMF, EDC and other systems as required in accordance with SOPs, guidelines and regulations in a consistent manger across individual studies
Develop and implement daily clinical research operations, including SOPs and process improvements review and development to meet corporate goals and objectives in a fast-paced environment.
Ensure that Clinical Operations interfaces with key global functional groups (Medical Affairs, Statistics, R&D, Manufacturing, Sales, Marketing, Regulatory affairs) to drive cross-departmental initiatives.
Experience with implementing complex and integrated clinical systems to drive data integrity and efficiency. Systems include EDC, IWRS, imaging, CTMS and eTMF systems.
Provide operational and management level representation during internal and external audits.
Oversee the clinical department employee and vendor training and associated requirements.
Select and develop systems and tools to drive streamlined, focused data collection and production and metrics tracking with an emphasis on data integrity and validity
Maintain knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to Abiomed products.
Proven track record (5+ years of experience) in similar role required with an emphasis on organizational and operational excellence. Experience in both US & EU pre- and post-market studies desired.
Advanced people management skills
Multiple years experience as the main interface with outside ARO/CRO groups in Class III cardiovascular devices.
Knowledge of cardiovascular medical terminology. Experience in cardiovascular studies would be a strong advantage.
Up to date expertise with GCP and global regulatory compliance guidelines for clinical trials and registries
Proven team player driven by service mindset
Positive, self-starter person looking for growth and making a difference in patient lives
Willing to work in an extremely fast paced environment high attention to details and accuracy.
Excellent prioritization and organizational skills
Experience in organizational design in a high growth environment
Data driven with deep knowledge of data production processes for a globally regulated function.
Excellent interpersonal communication skills.
Works effectively on cross-functional teams.
Presents confidently in a professional manner and appearance.
~20% travel to Vendors and Conferences
Abiomed (NASDAQ: ABMD) is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. CEO, Chairman, and President Michael R. Minogue has focused the company’s efforts on developing ground-breaking technologies designed to improve the patient outcomes focused on native heart recovery. Founded in 1981 for the purpose of developing the world’s first artificial heart, Abiomed has remained dedicated to finding ways to bring the most advanced and beneficial technology to patients and physicians.