Manager, TMF Compliance Management (DG)
Job Location: Parsippany, NJ (see all jobs in NJ)
Work Type: Remote
Date Posted: 2021-12-15
Manager, TMF Compliance Management - REMOTE
Manager, TMF Compliance Management is responsible for overseeing documentation, training, and metrics relating to the Global Regulatory Clinical Services Teams, including ensuring regulatory inspection-readiness and compliance with applicable global laws and regulations.
Managing the creation and maintenance of Controlled Documents, Training modules, materials, and job aids for the Global Regulatory Clinical Services Teams. Oversees continuous improvement activities, lessons learned and metrics to improve inspection readiness outcomes and report risk and improvements to the business for ongoing review. Liaising with other functional areas, eLMS administrators and CRO stakeholders to ensure consistent processes and procedures for the management of the Global Regulatory Clinical Services team. This position will be required to work collaboratively with group members, business leaders, and contribute to positive team relationships, both locally and globally. This role will serve as a point of contact for inspection or inspection preparations and as the subject matter expert on the processes and future improvements for the Global Regulatory Clinical Services team.
Manage all Controlled Documents, training material and job aids associated with Global Regulatory Clinical Services Teams. Ensure, as required, the materials are created or updated with consultation of the applicable stakeholders internally or externally. Perform instructor led training, as required. Runs and monitors metric reports across the company, each business group and CRO. These reports will be analyzed and trended to identify / suggest areas of quality improvements or risks to inspection readiness. Lead and/or assist in Improvement efforts with appropriate stakeholders on lessons learned and corrective actions associated with TMF and/or Safety Reporting quality, TMF completeness, Safety Alert Reporting data collection from the study teams and document timeliness issues identified through the metrics analysis. Serve as a representative for TMF Management within Inspection, to speak regarding the overall TMF process and future improvements, as required. Assist the Safety Alert Reporting Team with preparing and gathering documentation as requested during inspections. If applicable, manage the day-to-day activities of direct reports.
Bachelor's degree is required. Min of 5+ years’ experience working hands on with either TMF management or Safety Alert Reporting, preferred including min of 2+ years of experience in pharmaceutical environment. Some supervisory/line managing experience preferred. Must have good understanding of clinical development, including US and international regulatory requirements (including ICH and GCP guidelines) for the conduct of clinical trials and related regulatory documentation and be able to interpret and make decisions based on these guidelines. Must have strong knowledge of and be able to differentiate all key clinical trial documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents). Must have strong document management skills, including experience with review of Regulatory Documents, be quality driven and able to work in a team environment under tight deadlines. Must have advanced critical reasoning skills, including the identification and resolution of complex problems. Must be proficient in MS Office. Shows high level of initiative and has ability to work independently. Must have strong verbal, written and interpersonal communication skills, especially needed to work in and effectively manage a cross-functional team. Ability to drive cross-functional projects with conflicting priorities. Must be very detail oriented and possess excellent organizational and time management skills. Must possess a customer service mindset when interacting with stakeholders especially when working towards conflict or issue resolution.
Please contact Darren Gutowski at firstname.lastname@example.org
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