Senior Clinical Systems Specialist

Precision for Medicine is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.

Due to growth we are seeking a Senior Clinical Systems Specialist. This position can be offered fully home based.

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

• Serve as a subject matter expert (SME) and support Clinical Systems management for Precision CTMS.
• Collaborate with study teams to set-up of studies, manage access to the study CTMS, and work with data management and clinical programming to implement integration with EDC.
• Assist with new version releases and configuration changes, including development, testing, and validation oversight or as needed User Acceptance Test (UAT) execution.
• Manage end-user and group permission settings.
• Manage the collection, mapping and upload of data from 3rd party EDC Vendors into the CTMS.
• 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.
• Participate as required in inspection/audit preparation activities and assist in the development / execution of CAPA plans.
• 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.
• 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.
• 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.

The ideal candidate will have:

• Degree, or equivalent, ideally in a business, scientific or healthcare discipline
• Previous experience working with Clinical Systems ideally within a CRO/Pharma organisation

Other Required:

• 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
• Must be a team-player, punctual and reliable, dependable, and flexible in adapting to change in a multi-disciplinary, fast-paced work environment

Preferred:

• Proven ability to collaborate in a team environment and work independently
• Excellent oral and written communication skills
• Proficient in MS Excel
• 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.

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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

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].