CTMS System Specialist (Remote)

Position Summary

We are seeking a responsible, dynamic, creative and highly motivated CTMS System Specialist to join our Clinical Operations Department. This full-time position will provide leadership, serve as a subject matter expert, manage vendor oversight and provide the clinical study team with the support required to ensure that the Clinical Trial Management System (CTMS) and other systems (i.e. EDC, Drug Safety, IXRS, ETMF, etc) are managed in accordance with relevant ICH/GCP guidelines/regulatory requirements, Precision SOPs, project-specific plans and other guidelines, as appropriate. This position will collaborate with IT to define and deliver solutions that successfully meet the above objectives. Responsible for combining clinical operations and technology skills with strong leadership, communication, negotiation, facilitation, and presentation skills. Provides technical guidance and support with respect to the CTMS and other systems.

Essential functions of the job include but are not limited to:

• Provide advanced System Administrator management of Precision 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.
• Collaborate with vendor on the ongoing CTMS system issues, upgrades, and maintenance.
• Act as a liaison between end-user groups using the system and the system developer.
• Collaborate with study team leads 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
• Work with data management and clinical programming to establish potential for integration with EDC.
• Manage end-user and group permission settings.
• 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.
• Interact with Precision IT staff and other technical staff to support data integration between CTMS and other systems (i.e. EDC, Drug Safety, IXRS, ETMF, or other systems).
• Integrate CTMS activities in line with integrations with the corresponding eTMF as necessary.
• 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).
• Clinical Trial Management duties (as needed):
• Create and manage study timelines and milestones.
• Assist with the site status.
• Assess subject enrollment, status, visit dates, procedures, etc.
• Entry of monitoring visits, study activities, deviations, assist with trip report workflows, develop activity plans, etc.
• Monitor completeness and quality of the CTMS (from start up to final deliverable).

Qualifications

Minimum Required:

• Bachelor s Degree preferred.
• 2+ years of clinical research experience (CRA, CTM, PM, or other clinical research-related role) within a CRO is highly preferred.

Other Required

• 2+ years CTMS or other clinical program management system(s) experience
• Working knowledge of ICH-GCP guidelines and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content.
• Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects.
• Extensive knowledge of monitoring and site management; some knowledge of study management and reporting needs.
• Proven ability to collaborate in a team environment and work independently
• Excellent oral and written communication skills

Preferred

• Working knowledge of and experience with Medidata Rave CTMS
• Working knowledge of and experience with TransPerfect Trial Interactive eTMF
• Proficient in MS Excel
• Some experience with Adobe Acrobat, creation and development of editable/fillable Adobe forms
• MS project or other GANTT charting and milestone development is a plus
• Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. 2020 Precision Medicine Group, LLC

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