CTMS System Specialist I

We have a current opportunity for a CTMS System Specialist I in Europe! Join our growing team.

Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

We offer flexible location options, and remote based working. This position can be based in one of the following countries: Poland, Hungary, Serbia or Romania.

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 serve as a subject matter expert over CTMS, supports the Clinical Study team in the set-up and configuration of the system, as well as ongoing maintenance of the system for studies lifecycle. This position will collaborate with Clinical Systems Manager and IT to define and deliver solutions that successfully meet the above objectives. This position will collaborate with Clinical Systems leadership and IT to define and deliver solutions that successfully meet the above objectives. Responsible for combining clinical operations and technology skills with excellent independent work ethic, communication, 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 System Administrator management of Precision’s Clinical Trial Systems, serving as main subject matter expert (SME) for the CTMS and eTMF system.
• Assist with new version releases and configuration changes, including development, testing, and validation oversight or as needed User Acceptance Test (UAT) execution.
• 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.
• 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.
• Integrate CTMS activities in line with integrations with the corresponding eTMF as necessary.
• 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).
• Perform periodic reviews to ensure CTMS adoption and progress is timely and in line with the current stage of each program.

Qualifications:

Minimum Required:

• Bachelor’s Degree preferred.
• Clinical Systems team experience (within a CRO is highly preferred).

Other Required:

• Previous experience with CTMS and/or other clinical program management system(s) as a user, as well as a strong desire for a CTMS Systems focused role
• 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

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.