Freelance Clinical Systems SME – Maternity Cover 

Freelance Clinical Systems SME – Maternity Cover 

Location: Remote

Contract: Maternity Cover:

Starting March, approx. 8- 20 hours/week, depending on number of projects, 6 – 12 months 

Seuss+ specializes in optimizing partnerships between sponsors and vendors, ensuring that clinical trials are executed efficiently, on time, and on budget. We deliver strategic, hands-on support to biotech and pharmaceutical companies, helping them turn complexities into opportunities and ultimately accelerating the development of life-saving therapies.

About the Role

We are seeking a Freelance Clinical Systems Subject Matter Expert (SME) to join our team and support key client projects on Clinical Systems Analysis and Implementation, Digital Landscape Assessments and Computerized System Validation, during a colleague’s maternity leave. This role requires expertise in working with clinical technology used to operationalize clinical trials.  

Key Responsibilities:

Clinical Systems:

• Advise on Clinical Systems and clinical validation, including full system lifecycle management.
• Develop and approve electronic data flow diagrams and advise on how data flow can be made more efficient by sharing insights on existing integrations.
• Conduct risk-based assessments on identified computerized systems in the clinical trial.
• Review validation documentation to assess whether the computerized system is fit for purpose (IQ/OQ/PQ testing).
• Advise on clinical technologies that can add value to clinical trials to address specific challenge(s) a Sponsor might have.

Vendor and Technology Expertise:

• Maintains strong networks with vendors to identify and assess system options.
• Provide insights on innovative technologies, such as digital endpoints, wearables, and real-world evidence solutions.
• Documentation and Regulatory Compliance:
• Create and refine user requirement specifications (URS) and ensure alignment with regulatory requirements (FDA, EMA, GCP).
• Develop system and data inventories.
• Ensure archival and validation processes meet industry standards.

Gap Analysis and Improvement:

• Identify gaps in current systems and provide solutions for improvement.
• Create and deliver a clear systems overview, concluding with highly pragmatic steps to improve data integrity.

Skills and Qualifications:

Technical Expertise:

• Proficient in Clinical Systems, data flow mapping, and validation processes
• Understanding of regulatory requirements on computerized systems and data integrity
• Preferably a good network with clinical system vendors
• Familiar with IQ/OQ/PQ testing
• Experience writing user requirement specifications (URS)
• Has expertise and insights across the broader digital landscape in Life Sciences
• Knowledgeable about clinical technologies that can add value to clinical trials

Certifications:

• Strong knowledge of GxP compliance
• Tools and Systems:
• Expertise in validation documentation, URS creation, and interoperability solutions.

Experience

• Proven track record in creating and implementing data flow diagrams and supporting validation projects in clinical environments.
• Experience improving interoperability.
• Strong understanding of archival processes and regulatory documentation requirements.
• Prior work with innovative technologies such as wearables and digital endpoints is a plus.

Soft Skills

• Strong analytical and problem-solving skills.
• Excellent communication and collaboration abilities, particularly in meetings with stakeholders and project teams.
• Flexible and proactive approach to managing competing priorities.

Onboarding and Practical Considerations

Start Date: March 2024 (training and onboarding in January/February – tbd).

Hours: Approx. 20 hours per week (with flexibility for project demands).

Onboarding Support:

• Initial intake meeting and access to SOPs and project resources.
• Collaboration with internal team members for a smooth transition.