Clinical Project Manager

- Lund, Sweden or RTP, NC. Hybrid working is also available.

SAGA Diagnostics is a personalized cancer diagnostics and disease monitoring company focused on molecular genetic analysis of circulating tumor DNA (ctDNA). The company's mission is to improve precision cancer medicine, provide more accurate treatment monitoring, and improve patient survival using minimally invasive liquid biopsy cancer testing services. SAGA's proprietary tests can help patients, oncologists, and drug developers detect actionable mutations, stratify patient groups, and monitor treatment response, residual disease, and disease recurrence at unprecedented sensitivity and scale.

SAGA is seeking a talented and highly motivated Clinical Project Manager with a strong interest in advancing our mission to revolutionize cancer diagnostics through the use of liquid biopsies.

You will be a key member of the SAGA clinical development team, an international multi-disciplinary team, where you will plan, implement, and monitor the progress of clinical studies and be responsible for the overall clinical operational management. The trials and clinical studies may be either sponsored by SAGA or conducted in collaboration with academic, or commercial partners. We are growing our clinical development team and engaging with world leading KOLs and so this a unique opportunity to build the clinical research, reporting to the VP of Clinical Development.

This is an exciting opportunity to join a rapidly scaling cancer genomics startup with excellent momentum, international attention, and strong customer traction - where every role is critical. Through cooperation and teamwork, you will have the opportunity to help grow the company and make a real difference for people with cancer worldwide.

Key responsibilities:

• Provide effective project management of clinical research projects undertaken by SAGA in the US, EU and worldwide. You will work closely with academic and operational leads and commercial partners to ensure projects are set-up and delivered in a timely manner, resolving any issues through day-to-day clinical operational management
• Coordinate inbound clinical specimen shipments for assigned projects, ensuring accurate requisition documentation and coordination of any accessioning issues with lab operations and clinical sites, acting as a point of contact for clinical collaborators
• Coordinate with a project team of internal staff, involving wet lab personnel, bioinformatics and project management teams
• Set-up clinical supplies including lab kits, labelling and supporting documents in-house and in conjunction with third party service providers, as well as oversight of shipping logistics
• Responsible for training of collaborating investigators, project team and service providers including compliance with project plans, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines and other applicable regulations
• Participate in the development of analytical plans and study documentation, such as protocols, CRFs and informed consent documents, including essential document/TMF management where required. Prepare and review departmental Standard Operating Procedures (SOPs), guidelines, and intradepartmental procedures and other continuous process improvements programs, as assigned
• Design and implement plans for site selection, specimen collection, monitoring (in-house and contracted) and patient enrollment
• Support study budgets, contract negotiations and oversight of clinical service providers
• Potential for interacting with key external opinion leaders to help cultivate study ideas, collaborations and future protocol development
• Some travel will be required for this position (approximately 10%)
  
  

The exact accountabilities and responsibilities will be dependent on the skills and experience of the individual.

Requirements

Technical Requirements:

• Minimum degree in life sciences subject required
• Minimum 5 years of clinical research experience, some monitoring experience preferred.
• Experience of research/clinical trials in the oncology field, as well as laboratory study management, would be an advantage
• Familiar with ICH-GCP, IVDD/IVDR, CLIA and relevant regulations
• Computer literacy (including relevant software, such as Excel, Word, PowerPoint, Adobe plus specific regulatory packages)
• Experience in a Biotech/start-up environment would be advantageous
  
  
  

Skill Requirements:

• Excellent English oral and written communication skills, including experience in giving presentations
• Enjoys working in a regulated environment and willing to comply with SAGA Standard Operating Procedures and Policies
• Ability to manage multiple and complex projects and prioritize workload with attention to detail
• Able to take initiative and work independently
• Pragmatic and practical, highly motivated to ensure that studies meet challenging timelines.
• Able to identify issues quickly and propose options for resolution
• Flexibility towards work assignments, new learning and travel
  
  
  

Benefits

What we offer:

• The opportunity to build a critical clinical research portfolio from concept and develop exceptional data packages.
• As an early employee of the clinical research team, you will be involved in many aspects of the business and help set the direction/culture as we grow.
• You will be given the autonomy and resources to deliver to the highest level
• All the perks of a start-up - highly competitive salaries and benefits, flexible working, flat structure, and a dynamic work environment