Clinical Research Senior Systems Administrator - TD2

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary:

The Senior System Administrator provides leadership, serves as a subject matter expert, manages vendor oversight, and provides the clinical study team with the support required to ensure that the Clinical Trial Management System (CTMS), the electronic Trail Master File (eTMF) and other systems (i.e. EDC, Drug Safety, IXRS, etc.) are managed in accordance with relevant ICH/GCP guidelines/regulatory requirements, TD2 SOPs, project-specific plans and other guidelines, as appropriate. This role is responsible for combining clinical operations and technology skills with strong leadership, communication, negotiation, facilitation, and presentation skills.

Essential Functions:

• Serve as System Administrator of CTMS and eTMF Commercial off-the-shelf (COTS) Software.
• Maintain systems that are fully compliant with ICH, GCP and regulatory guidelines, including 21 CFR Part 11.
• Provide advanced System Administrator management of TD2’s Clinical Trial Systems, serving as main subject matter expert (SME) for the CTMS and eTMF system.
• Manage new version releases and configuration changes, including development, testing, and validation oversight or as needed User Acceptance Test (UAT) execution. Ensures that upgrades do not impact current data held within the software, software is accessible to users, and outputs from the software are as expected.
• Collaborate with study teams to lead the set-up of studies, study teams and sites in the CTMS ensuring programs are configured according to the specific study requirements including: countries and sites; grant access for internal, sponsor and 3rd party vendor users; baseline expected deviation categories, study/visit plans, visit report & letter templates and baseline milestones
• Manage end-user and group permission settings.
• Collaborate with vendor on the ongoing CTMS system issues, upgrades, enhancements and maintenance.
• Act as a liaison between end-user groups using the system and the system developer.
• Maintain proper system documentation (e.g., Release Notes, Validation Testing Plan, Validation Reports, Validation Certificate) as applicable and provide for filing within TD2 Quality Assurance.
• Monitor system performance and request support from the service provider Helpdesk and content experts as needed to support system usage.
• Create and maintain system SOPs, Working Guidelines, and training materials.
• Advocate for system updates and modifications with the service provider, as needed, based on personal system usage and through end-user feedback.
• Provide adequate training of system functionality to study teams, including external partners sponsor and/or site staff, to ensure that study teams have the guidance needed to work CTMS features independently and meet periodically with study teams to offer ongoing support.
• Create and/or provide input for the creation of work instructions/job aids, assess global & project specific trip report & letter templates, assist teams with workflows and provide training materials/tools as needed.
• Perform periodic reviews to ensure CTMS adoption and progress is timely and in line with the current stage of each program.
• Lead meetings to escalate trends, issues, and establish standards based on current industry standards, while problem solving and seeking appropriate endorsement across study teams and functions. Communicate ideas, solutions, and standards.
• Continually assess that CTMS features are functioning properly and efficiently; track all issues & observations for future enhancement, bug fixes, or ongoing needs for training of CTMS features for continuous improvement of the management of the system.
• Meet regularly with vendors to communicate CTMS and eTMF needs and manage all issues & observations to resolution.
• Assist Proposal Development & Sales with writing CTMS descriptions for RFIs and proposals; also assist with the development and presentation of slides for client presentations (e.g. bid defense and kick-off meetings).
• Maintain a folder of trial CTMS documents and training certificates for inclusion in the Trial Master File (TMF).
• Continually grow personal skill level on CTMS and TMF systems.
• Lead integration with Electronic Data Capture systems by partnering with the Data Management team to Independently prepare and manage weekly external EDC ingestions with Cyberduck raw data files inputs, configure internal EDC tagging, and perform external EDC clinical trial Ingestion User Acceptance Testing (UAT).
• Assist users in obtaining department metric reports as outputs from the CTMS system.
• Assist with Clinical activities, as needed, such as maintaining TD2 Controlled Documents within the Learning Management System (LMS).
• Perform other duties as assigned.

  
  

Job Requirements:

• Bachelor’s degree is required, preferably in a health science field.
• 2+ years of clinical research experience (CRA, CTM, PM, or other clinical research-related role) within a CRO is highly preferred.
• Minimum five (5) years’ experience working in CTMS and TMF systems as clinical program manager.
• Knowledge in pharmaceutical drug development with experience in oncology as a therapeutic area is preferred.

Required Specialized/Technical Skills:

• Knowledge of GCP, ICH guidelines and FDA regulations.
• Experience with CTMS, including acting as CTMS Administrator.
• Experience with eTMF, including acting as eTMF Administrator.
• Strong working knowledge of computer programs including CTMS, eTMF, and MS Office products including Word, Excel, and PowerPoint.
• Prior experience with clinical research with an understanding of clinical operations including clinical trial design, study implementation, CRA/site management, and data management.
• Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects.
• Advanced communication and problem-solving skills.
• Able to work under tight timelines.
• Ability to lead internal and external meetings with appropriate meeting note taking and follow- through of action items.

  
  

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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