Manager Development Operations Systems
JR000008637 Manager Development Operations Systems (Open)
US Specialty Brand Headquarters - USA501
The Clinical Operations System Manager will report to the Director, Clinical Operations and will serve as the primary S&T organizational lead for systems utilized for development operations. Currently, these systems include eTMF, CTMS, SharePoint and Clinical Trial Disclosure systems, but could include others as the need evolves.
Clinical Trial Disclosure systems are registry and results databases of publicly and privately supported clinical research conducted in the United States and around the world. Both registration and results submissions are accomplished through the Web-based Systems. This Role will be responsible to register trials and submit results in compliance with Registry requirements and appropriate Regulations. The successful candidate will be responsible for ensuring understanding of global requirements for Clinical Trial Disclosure obligations.
An electronic trial master file (eTMF) is a formalized means of organizing and storing documents, images and other digital content for clinical trials that may be required for compliance with government regulatory agencies. The term eTMF encompasses strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content.
A clinical trial management system (CTMS) is a software system used to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones. The successful candidate will serve as a Business Owner and functional SME for Mallinckrodt's current systems as well future systems.
The successful candidate for this position will be responsible for registering and reporting results for sponsored studies for Clinical trial disclosure worldwide. The successful candidate will be responsible for the Clinical Operations hotline and central mailbox. The successful candidate will be responsible for set-up and managing user profiles, training content, training and will support the lifecycle management within the eTMF and CTMS applications. The candidate will be responsible for managing the pre-and post-operational tasks for clinical studies.
Provide leadership and serve as a subject matter expert (SME) for Clinical Trial Disclosure and Transparency activities
Monitors, communicates and plans responses for change in global Clinical Trial Disclosure and Transparency Regulations
Collaborates with cross-functional stakeholders (Clinical Science, Development Operations, Safety/PV, Biostatistics, and Regulatory etc.) and Contract Research Organizations
Perform project management coordination and execution of Clinical Trial Disclosure and Transparency Activities to ensure company sponsored trials are disclosed in accordance with global laws, regulations and policies.
Communicates timelines, reviews protocol information, gathers additional information, prepares documentation, conducts reviews and posts to regulatory agencies portals
Ensure consistency of information posted with publications and other publically disclosed areas and creates a standard internal terminology database to improve efficiency.
Updates existing registries with changes in ongoing clinical trials related to protocol amendments, site updates, recruitment status and actual dates
Learn and remain current on appropriate Regulations and Registry requirements for posting and reporting results globally.
Creates a process for archiving registrations and results posting documentation and Creates process for data transparency deliverables
Assists trial teams, expertise areas and management with questions regarding public results disclosure and trains the organization on disclosure process.
Lead , manage, and monitor the Clinical Operations Central Contact hot line and mailbox of the Clintrials.gov, managing, handling and documenting caller inquires per SOPs
Serve as primary business lead for Development Operations systems (eTMF, CTMs etc., )
Set-up, and manage: user profiles, training content, training assignments,
Support Lifecycle management including release management, and issue management
Participates in User Acceptance Testing and Assist in creation and documentation for process improvement and new system requirements
Primary support for business specific tasks associated with compliance and functionality of these systems
In close partnership with IT, oversee the development, implementation, optimization, and maintenance of clinical systems (CTMS, TMF, etc) that support Mallinckrodt's clinical trials on an ongoing basis.
Serve as a source of Innovation, looking to bring new tools and technologies into Development Operations which could make the group more efficient
Serve as the system(s) and process(es) expert, by being a primary interface for end users and by performing role specific activities within and independent of the system(s), in compliance with standard operating procedures, processes, policies and guidelines, including, but no limited to creation and management of documents/materials, full lifecycle management of documents/materials making documents/materials effective, checking document/material progress/status, periodic reviews, withdrawing documents/materials, managing workflow participants, suspending and aborting workflows, recovering deleted documents/materials, managing offline processes, etc.
Manage Pre-study operations by assigning protocol numbers for branded programs
Maintain tracking of assignment and cancellation of protocol numbers
Manage Post-study operations by obtaining financial disclosure (FDA Form 1572) 1yr post study from participating sites
Maintain tracking of post study FDF for due diligence
Collaborate with regulator to provide updated FDF information as necessary
Serve as Dev Ops SharePoint site administrator in order to re-configure/re-design our existing Site to create value and drive usage, etc.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.
Minimum 2-years' experience with analysis and reporting of clinical trial data.
Minimum 3 years' experience working a Pharmaceutical/Biotech/R&D environment
Background knowledge relevant to understanding and interpreting clinical trial data
Strong critical thinking, analysis, and problem-solving skills
Ability to critically appraise clinical trial design and methodology and to identify internal inconsistencies in clinical trial data reporting
Working knowledge of domestic and international regulations; Good Clinical Practice (GCP), FDAAA, ISO 14155, 21 CFR 803 MDR Reporting, 21 CFR 810, 21 CFR 801, 21 CFR 820 Quality System Regulation, ISO 13485, ISO 14975, Medical Devices Directive (MDD) and other regulations that affect Class II and III medical device compliance.
Detailed oriented with a high degree of organizational skills and be able to handle confidential materials.
Strong knowledge base of Sharepoint
Possess very strong PC computer skills
Able to accomplish work independently and as part of a team
Able to set and meet deadlines
Able to take a project from start to finish while working in a constantly changing environment
Handle routine details and unexpected changes without losing focus on projects; determine task priority and ensure deadlines are met
Team player as demonstrated by good communication/collaboration skills
Strong interpersonal skills, including the ability to remain calm, professional, diplomatic, and positive
Positive attitude and ability to establish and maintain positive working relationships
Reports to: Director, Clinical Operations
Organization: Global Development Operations Department
Scope: Works closely with Clinical Development, Sciences/Pharmaceuticals team
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.