Clinical Systems Manager

ICONMA; Thousand Oaks (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a Clinical Systems Manager to oversee the quality delivery of clinical systems. This exciting role involves leading system requirements meetings, collaborating with internal teams, and managing technical documentation to support clinical trials. The ideal candidate will have a strong background in clinical development, project management, and hands-on experience with clinical systems. Join a forward-thinking organization that values growth and offers excellent advancement opportunities in a supportive environment. If you're passionate about improving clinical processes and thrive in a collaborative setting, this is the perfect opportunity for you.

Benefits

Health Benefits

Referral Program

Growth Opportunities

Qualifications

• 4+ years of experience in clinical development with hands-on clinical systems experience.
• Strong knowledge of GCP and FDA regulations, PMP certification preferred.

Responsibilities

• Lead study-level system requirements meetings and manage project timelines.
• Support clinical trial platform technologies and manage user acceptance testing.

Skills

Clinical Development

Project Management

Problem-Solving

Communication Skills

Attention to Detail

Vendor Management

Team Collaboration

Education

Bachelor’s Degree in Life Sciences, Computer Science, Engineering, Business

Doctorate or Master’s Degree with clinical experience

Associate Degree with clinical experience

High School Diploma/GED with extensive clinical experience

Tools

CTMS

EDC

IVRS

ePRO

Medidata RAVE

Job description

Our Client, a Biopharmaceutical company, is looking for a Clinical Systems Manager for their Remote location.

Responsibilities:

• Accountable for quality delivery and ensuring team competencies within the service area
• Lead study-level system requirements meetings with vendors and internal stakeholders
• Assist in designing and developing study-specific technical documentation
• Support internal teams in managing project timelines and associated activities
• Collaborate with Data Management (DM) to define data transfer requirements
• Work with external partners to manage user acceptance test (UAT) creation and execution
• Identify, track, and resolve study-related technical issues
• Contribute to continuous process and quality improvement initiatives
• Support of clinical trial platform technologies
• Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight.
• Coordinating and providing programming support to Clinical Study Teams
• Coordinate and work with FSP team who are located globally and working remotely.
• Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards.
• Acting as a technical point of contact for systems deliverables on defined programs
• Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment.
• Providing technical and business process input / expertise on new and emerging technologies
• Develop, review and implement policies, SOPs and associated documents
• Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes.
• Assist in preparing for and responding to audit findings (internal or external).

Requirements:

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, Business, or related field
• 4+ years of experience in clinical development
• Hands-on experience with clinical systems such as CTMS, EDC, IVRS, ePRO, or similar technologies in the pharmaceutical/biotechnology industry
• Strong knowledge of Good Clinical Practices (GCP) and relevant FDA regulations
• Demonstrated project management and technical expertise
• High attention to detail with strong documentation and communication skills
• PMP certification (preferred)
• Prior vendor management experience
• Excellent time management and organizational abilities
• Strong problem-solving, judgment, and decision-making skills
• Ability to thrive in a team-based environment with minimal supervision
• Doctorate Degree or Master Degree and 3 years of clinical experience or Bachelor Degree and 5 years of clinical experience or Associate degree and 10 years of clinical experience or high school diploma/GED and 12 years of clinical experience
• Study Design & Edit check Programming in Medidata RAVE
• Coordinate and work with FSP (Functional Service Provider) team
• Coordinating and providing programming support to Clinical Study Teams

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.