Clinical Operations Manager

Purpose of the Job:

To support ongoing clinical trial development projects in the United States market and liase between CROs, vendors, trade organizations and surgeon conferences that are relevant to the clinical development program.

Principal Accountabilities (Major duties):

Assist through the following:

• Adherence to the management policy of the CeramTec Group
• Compliance with rules of the quality management system and associated standards and regulations
• Preparation and maintenance of regulatory documentation for internal and external purposes, considering the regulatory requirements; including monitoring, analysis, and implementation of regulatory requirements.
• Support the Regulatory Affairs department with ongoing projects, focus on the US; analysis of applicable regulatory requirements; preparing / review of regulatory documentation for submission to authorities.
• Prepare clinical study-specific submissions as well as other required documents.
• Organization and management of clinical study data and documentation; support in preparation of related reports for regulatory authorities
• Generate Clinical Trial SOPs for new development project including site feasibility, site selection, study start-up, lifecycle management and site closure activities.
• Provide regulatory input and advice on the creation, implementation, and revision of SOPs.
• Generate Essential Document Package templates for the Trial master file (TMF)
• Monitor the overall clinical study documents in the TMF as well as the site documents in the TMF.
• Identify time delays in the clinical development programs.
• Facilitate the development of clinical trial plans in sync with defined program timelines, ensuring cross-functional input and verification.
• Trial and indication critical path analyses to bolster optimization of trial planning, allocation & feasibility, and scrutinizing risks to trial delivery.
• Engage in scenario planning to aid the trial management team in outlining the strategy for trial execution.
• Identify gaps and risks in the trial plans and collaborate to prepare solutions aimed at augmenting efficiency and curtailing timeline overruns.
• Provide trial-specific timelines and/or dashboards to management teams to spotlight past due and upcoming tasks and milestones.
• Provide trial project status reports to key stakeholders as needed.
• Conduct critical path analysis to drive the optimization of trial execution and assess risks to milestone delivery.
• Employ timeline tools and planning strategies to enable data-driven decisions in support of trial execution.
• Interface communication with the CRO and other parties in context of clinical studies; support with clinical site monitoring as necessary
• Preparation and assistance with site audits/inspections
• Regulatory support of other departments, e.g. within Registration with FDA, Customs clearance or Medical Device Reporting
• Support of monitoring and reporting legal requirements, such as registering, reporting and archival
• Support of post study activities such as market surveillance, monitoring and adverse events reporting
• Internal contact for regulatory issues as well as regulatory support of the departments, review of the relevant documentation from the departments with regard to regulatory aspects
• Independent processing of additional projects / tasks in the area of Regulatory Affairs
• Training and continuing education in the area of Regulatory Affairs
• Regular access to confidential information
• Compliance with all regulations and rules

Requirements / Preferred Qualifications:

• BS degree preferably in Engineering discipline
• Previous experience working in Regulatory Affairs 3+ years, preferably medical devices.
• Knowledge of clinical trial documentation and regulatory requirements related to clinical trials is preferred.
• Knowledge of 21 CFR 820, ISO 13485
• Knowledge of Good Clinical Practices
• Experience with Veeva Vault or another Trial Master File Software
• Experience with FDA submissions and meetings e.g., Q-subs, IDE, etc.; experience with E-star submissions preferred.
• High-level comprehension of the end-to-end clinical trial planning and execution
• Familiarity in the use of Clinical Trial Management System and project management systems is a plus for milestone and driver tracking.
• Working knowledge of regulatory requirements for IDE, 510(k)
• Strong written and verbal communication skills
• Ability to manage projects, scopes, and timelines.
• Self-motivated and able to multi-task
• Conduct tasks according to SOPs and processes.
• Works in a logical, structured manner and is detail oriented.
• Team-oriented problem-solving ability
• Ability to work effectively independently (home office) and as part of a team.
• Ability to read and interpret the 21 CFR and the FDA’s Guidances
• Proficient in MS software and able to learn appropriate software.
• Excellent interpersonal and professional skills
• Some travel possible
• Located in eastern or central time zones.
• Remote work (home office) 90%