A dynamic biopharmaceutical company is seeking a Clinical Trial Associate (CTA) to support the Clinical Operations team across all aspects of study management. This role focuses on TMF oversight, clinical documentation, and day-to-day project coordination within a fast-paced, outsourced environment.The organization is dedicated to developing innovative therapies for patients with rare diseases. Their mission is to deliver impactful treatments by running high-quality, patient-focused clinical trials with efficiency and precision.Key ResponsibilitiesTMF & Documentation: Manage eTMF setup, quality control, audit readiness, and archiving; support Sponsor oversight and documentation compliance.Clinical Support: Track study milestones, organize training records, assist with vendor coordination, meeting scheduling, and material distribution.Project Coordination: Provide administrative support to the Clinical team, take meeting minutes, and help ensure alignment with ICH-GCP and SOPs.Key RequirementsExperience: Previous experience in pharma/biotech; hands-on expertise with eTMF systems is essential.Skills: Strong organizational, multitasking, and communication skills; high attention to detail and proficiency in Microsoft Office and SharePoint.Attributes: Self-starter, adaptable, reliable, and able to work effectively in a small, collaborative team environment.

SciPro are partnered with a leading, privately held biopharmaceutical company and leading their search for a Director of Clinical Operations based in the UK to oversee and drive global clinical trial activities for a late-stage development program in rare diseases. This pivotal leadership role focuses on managing complex outsourced trials, ensuring timelines, quality, and regulatory compliance in a fast-paced environment.The company is committed to advancing a best-in-class monoclonal antibody therapy to address unmet clinical needs in rare macrophage-driven diseases. By combining deep scientific expertise with patient-centred innovation, the organization strives to significantly improve patient outcomes and quality of life.Key ResponsibilitiesClinical Trial Oversight: Lead end-to-end global trial planning and execution, managing multiple CROs and vendors, and ensuring delivery on time and within budget.Stakeholder & Team Leadership: Act as a key liaison between cross-functional teams and senior leadership, while mentoring team members and guiding resource allocation.Compliance & Risk Management: Ensure adherence to GCP, ICH, and regulatory guidelines, maintain trial documentation readiness, and proactively manage operational risks.Key RequirementsExperience: Proven track record in clinical project management, ideally within biotech or fast-paced start-up environments; extensive knowledge of trial regulations and processes.Skills: Strong leadership, communication, and analytical skills; adept with tools like CTMS, eTMF, EDC (preferably Medidata RAVE), and Microsoft Project.Mindset: Highly organized, proactive, and flexible with a hands-on approach; comfortable working autonomously and contributing across functional areas when needed.