Project Coordinator - Biometrics

Job Title: Project Coordinator - Biometrics (Clinical Trials)

Location: Remote - EU region. Client based in the UK

Job Type: Full-time

Salary: Competitive, based on experience

About Us:

CK QLS are working with a Global Pharmaceutical company, that specialize in advancing clinical trials and biometrics solutions to support life-changing research. We are looking for a skilled and proactive Project Coordinator with experience in the clinical trial process to support our growing team. This is a fantastic opportunity for an organized and dedicated individual to contribute to impactful clinical trials, focusing on statistical programming, biostatistics deliverables, and ensuring the highest quality standards in every step of the process.

Key Responsibilities:

• Support for SQS Team:

  Provide support for the SQS team while collaborating cross-functionally with stakeholders as needed.

• Clinical Trial Process Knowledge:

  Apply working knowledge of the clinical trial process, including familiarity with statistical and programming deliverables and milestones. Statistical programming or biostatistics knowledge is preferred.

• Organizational Tool Proficiency:

  Utilize tools such as Excel, SharePoint, Smartsheet, Power Applications, and other organizational tools to streamline project processes. Dashboard building skills are a bonus.

• Coordination and Communication:

  Act as the primary point of contact (POC) across various functions (e.g., study/project teams, stakeholders, IT, management, finance). Manage and prioritize assignments and tasks, ensuring timelines are met and communication is efficient.

• Timeline & Document Management:

  Develop and maintain project timelines, documentation, and communication tools. Streamline communication by clearly defining communication channels across all functions.

• Facilitate Project Meetings:

  Lead and facilitate project meetings with internal and external teams. Capture meeting minutes and follow up on action items.

• Report & Tracker Development:

  Assist in developing reports, trackers, and presentations, ensuring all functional teams and stakeholders are aligned.

• Issue & Risk Management:

  Track and manage project issues, risks, and dependencies, ensuring project goals are met on time. Support process improvements to eliminate inefficiencies.

• Documentation Implementation:

  Develop and manage key project documents such as communication plans, training handbooks, and engagement handbooks. Ensure proper access to documents and secure portals for all stakeholders.

• Systems & Documentation Oversight:

  Oversee systems and documentation related to the project. Monitor project finances and ensure adherence to budget guidelines.

• Quality & Risk Management:

  Develop and implement a comprehensive Quality Management Plan. Identify quality metrics, establish benchmarks, and monitor adherence to quality standards throughout the project lifecycle. Conduct quality audits and ensure compliance with regulatory requirements. Experience with Root Cause analysis and tools like TrackWise is a plus.

• Metrics Analysis & Strategy Implementation:

  Track, analyze, and report key performance indicators (KPIs) for clinical studies, statistical programming, and biostatistics deliverables. Implement risk mitigation strategies based on identified trends and metrics.

• Clinical Trials:

  3+ years of experience in the clinical trial process, with a solid understanding of statistical and programming deliverables and milestones.

• Organizational Tools:

  Proficiency with Excel, SharePoint, Smartsheet, Power Applications, and other organizational tools. Dashboard building experience is a plus.

• Project Coordination & Management:

  3+ years of experience in project coordination or project management roles, with demonstrated success in developing and maintaining timelines, documents, and communication tools.

• Communication & Collaboration:

  Strong organizational and communication skills, with experience acting as a primary point of contact for multiple functions. Skilled in facilitating and leading project meetings with cross-functional teams.

• Quality & Risk Management:

  Experience in developing, implementing, and overseeing a Quality Management Plan. Familiarity with quality metrics, benchmarks, and compliance with regulatory requirements. Experience with Root Cause analysis and tools like TrackWise.

• Metrics Tracking & Analysis:

  Proven experience in tracking and analyzing metrics for clinical studies, project milestones, statistical programming, and biostatistics deliverables. Ability to establish and maintain robust metrics tracking systems.

• Change Management & Process Improvement:

  Experience in change management and process improvement initiatives. Ability to lead internal gap analysis and implement strategies based on identified metrics.

• Education:

  Bachelor’s degree in Life Sciences, Clinical Research, Biostatistics, or a related field.

If you're passionate about project coordination, clinical trials, and biometrics, and are ready to make an impact, we want to hear from you!

Apply now by submitting your resume and cover letter to Rob Angrave at CK QLS on rangrave@ckqls.ch. Please quote job reference 123 067 in all correspondence.