Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a IT Project Manager - Biometrics Business Systems to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Job Summary:

This position supports the centralized management of technology, platforms, inspections, and related process and training for the global Statistical Programming organization. The individual supports the organization to ensure it operates in compliance with departmental and company SOPs, regulatory requirements, and standards.

Primary Activities:

Business System Ownership (BSO) of platforms or applications and corresponding documents and training
Partnership in managing, prioritizing, and implementing portfolio projects
Drive compliance initiatives, change management and communication
Supports audit and inspections Center of Excellence with audits, inspections and CAPA (Corrective Action and Preventive Action) management
Engagement with operational staff and partners globally
Lead and actively contribute to departmental strategic initiative project teams
Maintenance of SOPs, corresponding processes, assuring they are of high quality and complaint with regulatory requirements

Additional responsibilities as delegated by manager.

Education and Minimum Requirement:

BA/BS in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus 5-8 years in a clinical trial environment (Analysis & Reporting, Information Technology (IT), Data Management etc.) in the pharmaceutical industry, and 3-5 years SAS or R programming experience.

MS in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus 2-5 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and 3-5 years SAS or R programming experience.

Department Required Skills and Experience:

Effective interpersonal skills and ability to negotiate and collaborate effectively
Effective written, oral, and presentation skills
Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders

Position Specific Required Skills and Experience:

Comprehensive knowledge of reporting processes (SOPs) that align with regulatory requirements (e.g., 21 CFR Part 11, ICH GCPs) and software development life cycle (SDLC)
Understanding of Statistical, Clinical, Medical Monitoring and Data Management concepts as applied to drug/vaccine development within the pharmaceutical industry
Broad knowledge of clinical trials processes, data structures and corresponding tools used to manage, extract, analyze & report data
Demonstrated success in the assurance of deliverable quality and process compliance
Ability to anticipate stakeholder requirements; focus on customers; ability to listen to and address stakeholders’ needs and concerns
Ability and interest to work across cultures and geographies including partnering with statistical programming staff in AP and EU regions and offshore programming resources
Demonstrated ability to communicate effectively across multiple audiences and clearly explain processes and system functionality to users
SAS or R programming experience.

Preferred Skills and Experience:

Experience with SDLC, ALM, SAS, R, Jira, Confluence, Agile, Digital SDLC
Experience developing and managing a project plan
Experience as a System Business Analyst (BA)
Experience developing and maintaining process documents e.g., SOPs
Experience in process assessment, improvement, and operational excellence
Active in professional societies.

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IT Project Manager - Biometrics Business Systems(Remote)

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