Clinical Project Manager (Associate Director, Director)

Q32 BIO is advancing novel therapeutics to treat autoimmune and inflammatory disorders. We aim to deliver life-changing treatments for patients with a variety of diseases for whom no adequate treatment options exist.

With one program about to enter the clinic and another planned within the coming year, we are looking for an experienced Clinical Project Management professional to plan, manage and execute our clinical programs. This person will also assist in the management of external collaborators, consultants and CROS to ensure all timelines and budgets are met.

RESPONSIBILITIES:

• Contribute to clinical development plan (CDP) and clinical trial protocol development
  • Lead interactions with Q32 team, CRO and investigators to refine and finalize protocols
• Study execution: responsible for in-house management of 1 - 3 clinical studies
  • CRO/Vendor management: vendor selection & initiation activities
    • Responsible for feasibility assessments, investigator/site selection and qualification and vendor selection
    • Responsible for site startup: IRB/EC submissions and responses, collection and review of initial regulatory documents, planning of kickoff meetings and site initiation visits
    • Supports the tracking of actual spend to the approved budget including the communication of deviations to the budget.
  • Manages the relationship with CROs and deliverables delegated to CROs
    • Provides day to day direction/supervision to vendor teams, oversight and quality management to ensure CRO meets negotiated timelines and budget
    • Leads the development, review and approval of study documents (e.g., ICF, clinical monitoring plan, EDC/Case report Forms, pharmacy manual, oversight manual, SAP, CSR, etc)
    • Set study goals and timelines (including enrollment) and manages vendor deliverables within timelines; proactive and timely identification, escalation and solution of issues arising
    • Accountable for developing and managing overall study budgets & working with Finance to track forecasts and accruals
    • Provide regular and timely updates to the Study Team and senior management, as appropriate
  • Accountable for ensuring accurate and timely data collection, cleaning and analysis
    • Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems
    • Ensures the setup and maintenance of the sponsor Trial Master File
  • Contributes to the design and preparation of other study documents (including CSR and interim data disclosures)
    • Oversees generation of Tables, Listings and Figures (TLFs) as well as managing deliverables such as the Clinical Study Report (CSR)
    • Assists in preparation of regulatory submission packages
  • Develops Clinical Operations departmental best practices
    • Develop and/or review SOPs
    • Remains up-to-date on FDA regulatory requirements and ICH/GCP guidelines, and ex-US regulatory processes as required
    • Work closely with CMC to ensure appropriate clinical supply and drug supply forecasts

REQUIREMENTS/QUALIFICATIONS:

• Bachelor's degree or equivalent in a scientific or healthcare discipline
• 8+ years of clinical operations and study management experience in oncology clinical and drug development.
  • Effective leadership of multiple cross-functional study teams
  • Experience in project planning, and identifying and managing risk
  • Experience in setting and managing trial budgets, site selection strategies, clinical supplies management, sample management, conduct and monitoring of clinical studies
• Experience in managing and partnering with Early Phase CRO's to deliver a broad range of CRO services
• Strong communication skills with both internal and external stakeholders
• Ability to work independently in a fast-paced environment with minimal supervision
  • Working knowledge of regulatory and ICH GCP guidelines
  • Anticipated travel up to 20% (peak)