Merck- IT Project Manager - Biometrics Business Systems

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.

#LI-TT1 #LI-Remote #Senior #Contract