Clinical Systems Manager

ICONMA; Holly Springs (NC); Remote; USD 90,000 - 120,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Clinical Systems Manager to oversee Laboratory systems deployment and validation. This role demands extensive experience in QC systems and offers excellent growth opportunities. Join a dynamic team committed to innovation and quality in healthcare.

Benefits

Health Benefits

Referral Program

Excellent growth and advancement opportunities

Qualifications

• 10+ years of experience leading Laboratory systems implementations.
• Experience in QC computer system validation and technical writing.

Responsibilities

• Provide validation and qualification support for Laboratory systems.
• Monitor Laboratory application performance and resolve issues.

Skills

Communication

Problem Solving

Education

Doctorate or Master’s Degree

Bachelor’s Degree

Associate Degree

High school diploma/GED

Tools

MS Office

Sample Manager LIMS

CIMS

LMES Smart Lab

Job description

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

Responsibilities:

1. Provide validation and qualification support for Laboratory systems deployment.
2. Manage system master data builds and eProcedure Qualification support.
3. Provide technical guidance for templating efficiencies within LIMS.
4. Support incident management as required.
5. Monitor Laboratory application performance and resolve label printing issues.
6. Identify technical and operational gaps and propose solutions.
7. Provide hypercare support during system go-live.
8. Run LIMS queries based on business needs.

Requirements:

1. Experience in executing QC computer system validation and supporting/administering systems in a production environment. Ability to develop, write, edit, and format SOPs, manuals, and technical documentation. Manage document processing per established review processes.
2. Effective communication through various media (e.g., intranet, online training).
3. Proficiency in MS Office, technical writing, regulated environment experience, document version control, and excellent communication skills.
4. Educational and clinical experience requirements:
   • Doctorate or Master’s Degree with 3 years of clinical experience.
   • Bachelor’s Degree with 5 years of clinical experience.
   • Associate Degree with 10 years of clinical experience.
   • High school diploma/GED with 12 years of clinical experience.
5. Experience building master data for QC Laboratory Systems.
6. Troubleshooting technical issues.
7. Running queries for data reporting.
8. Over 10 years of experience, strong problem-solving skills, and previous Pharma experience.
9. Experience with Sample Manager LIMS, CIMS, LMES Smart Lab.
10. Strong technical knowledge to support deployment and support of Laboratory systems (LIMS/Electronic Smart Lab).
11. Minimum 10 years of functional experience leading Laboratory systems implementations, qualifications, and master data builds.

Why Should You Apply?

1. Health Benefits
2. Referral Program
3. Excellent growth and advancement opportunities

As an equal opportunity employer, ICONMA supports and encourages the abilities of all persons regardless of race, color, religion, gender, sexual orientation, gender identity or expression, ethnicity, national origin, age, disability, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by law.