Clinical Systems Leader (273233)

ASK Consulting

South San Francisco, CA, USA

Published: 6/14/2022

Technology

Full Time

Job Description

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Clinical Systems Leader

Location: South San Francisco, CA (Onsite)

Duration: 12 Months

PR: $45-$48.91/hr on W2

The Clinical Systems Leader (CSL) is responsible for implementing all related clinical systems actions
used in the development of clinical trials within Early Clinical Development (ECD). The CSL collaborates
with a cross-functional team of internal stakeholders and technology vendors to ensure the successful
implementation and maintenance of technology solutions supporting clinical trials.

Who You Are:

Bachelor's Degree in life science, computer science, engineering, information system, data science or related discipline
2-5 years of experience in Clinical Operations, or Clinical Systems Management
2-5 years of IxRS/IRT and clinical-related systems experience
Successful track records in leading the implementation of clinical systems, such as IxRS/IRT, ePRO, and eCOA
Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
Excellent written and verbal communication skills and strong project management skills
Familiar with documentation in a regulated environment.
Experience in Veeva is a plus

Primary Responsibilities:

Study Execution and System Management: Accountable for implementing all related clinical

systems, such as Interactive Response Technologies (IxRS) and electronic Clinical Outcome

Assessments (eCOA) actions for the ECD portfolio.

Project Management: Closely manage study-related timelines and associated activities. Manage

and lead the end-to-end specifications for the build of clinical systems for an assigned study or

enterprise project. This includes requirements review, testing, deployment, maintenance,

enhancement, and closeout.

Technical Oversight: Provide technical oversight to ensure that clinical systems solutions (e.g.,

IxRS/eCOA) adhere to the study protocol, industry regulations/best practices, and company

policies, procedures, and guidelines.

Collaboration and Teamwork: Work with a cross-functional team of internal stakeholders

(including but not limited to: Clinical Trial Leader, Biostatistician, Drug Supply Chain, Data

Management functions, and Procurement) and technology vendors. Work independently with PET

stakeholders and/or cross-functional project teams with little to no oversight. Works

collaboratively with the ECD I&A team to share knowledge.

Issue and Risk Management: Proactively identify and track study-level technical issues to

resolution. Ensure prompt resolution of system issues, document issues and risks, and

implement mitigation plans in partnership with the study team and technology vendor project

manager.

Communication & Presentation Skills: Strong verbal and written communication skills; strong

business presentation skills; Able to explain technical issues and communicate clearly, concisely,

and professionally with internal, external stakeholders and departmental leadership.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.