Clinical Systems Manager - Clinical Trial Services

Location: Carlsbad, California US

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Job Id: 2634

Position Title: eTMF Systems Specialist

External Description:

Why should you considering joining us? Because Precision for Medicine, Oncology & Rare Disease is not your typical CRO. As a member of our thriving team, opportunities to work with leading subject matter experts who understand the rare disease patient mindset and experience will surround you. We help translate science into success for rare disease patients with a targeted, patient-centric approach over a wide geographic area. We are specialists who tackle unusual problems in our detailed approach throughout every phase. From the beginning, we have nurtured a culture where patients’ needs and the needs of our valued clients come first. We focus in an environment where the quality of our work is the best, and where our employees can thrive, while still having fun and giving back to the patient community.

We welcome your voice and opinions and provide you with the ability to truly make an impact on drug development. Are you ready to be part of a close-knit clinical trial team that is passionate about saving the lives of patients every single day? Then look no further, we’d like to help you take your career to the next level. If the duties below sound like a fit, we’d love to hear from you!

About you:

  • You love state of the art technology and the thrill of testing and implementing new systems
  • Clinical research is your passion and your role as a CTA or CRA has been fulfilling but that "techie" side of you wants to be in the forefront of your career
  • You have mastered electronic Trial Master Files and thrive on being a subject matter expert and sharing your knowledge with others
  • Let your natural born communication skills shine as you take on a leadership role and guide yourself and others to success

As the eTMF System Specialist, you will provide leadership and be the subject matter expert for the electronic Trial Master File (eTMF). Your strong Vendor management oversight and clinical study team support will be vital to your daily activities. Combining your clinical operations and technology skills, you will collaborate with IT to define and deliver solutions to successfully meet your objectives and goals in this exciting next step in your career.

Take your place on a team that allows you to thrive. Be an empowered employee and help make the changes you want to see for patient care.

What you can expect day to day:

  • Provide advanced System Administrator management of the (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 eTMF system issues, upgrades, and maintenance
  • Serve as the liaison between end-user groups using the system and the system developer
  • Provide adequate training of system functionality to study teams, including external partners, sponsor and/or site staff, to ensure that TMF documents are processed in a timely manner and as outlined in the TMF Plan
  • Lead inspection/audit preparation activities and develop CAPA plans, as necessary, for related findings in conjunction with cross-functional leaders.
  • Manage processes and procedures for filing, retrieving, storing, preserving, and protecting of clinical records and identify areas for continuous improvement
  • Oversee the set-up of studies and sites in the eTMF

Qualifications:

Minimum Required:

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

Other required:

  • 2+ years Trial Interactive eTMF or other eTMF system(s) management 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 for the support and prioritization of multiple projects
  • Familiarity with the Trial Master File Reference model and a demonstrated understanding of records management best practices
  • Extensive knowledge of clinical documents that are maintained in the eTMF

Preferred:

  • Proven ability to collaborate in a team environment and work independently
  • Excellent oral and written communication skills
  • A team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment

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. © 2018 Precision Medicine Group, LLC

 

Division: Precision For Medicine

Business Unit: Oncology & Rare Disease

Office Based: Carlsbad - 6005 Hidden Valley Road, Suite 170, Carlsbad, CA 92011

Employment Type: Exempt

Employment Status: Regular Full-time

Work From Home Available: No

City: Carlsbad

Country: United States

State: California

Community / Marketing Title: Clinical Systems Manager - Clinical Trial Services

Company Profile:

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

EEO Employer Verbiage:

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. © 2018 Precision Medicine Group, LLC

Location_formattedLocationLong: Carlsbad, California US

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

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© 2019 Precision Medicine Group, LLC. All rights reserved