[Hiring] Senior Project Manager, Clinical Adjudication @Calyx

Role Description

As Senior Project Manager, Clinical Adjudication, you are primarily responsible for managing all, end-to-end, clinical event adjudication processes for multiple, large, complex clinical trials, ensuring they are delivered on time, within scope and budget. The role requires a high degree of autonomy, advanced judgement, and ownership of delivery outcomes, including cross project risk management, financial performance, and client satisfaction. In this role, you are also responsible for coaching and mentoring less experienced team members and developing capability within the clinical adjudication team.

Key Accountabilities

• Project Management
  • Accountable for delivery performance, quality, and compliance across multiple projects or complex programmes.
  • Manages projects within contracted scope in adherence with relevant Company SOPs and applicable regulatory standards (i.e., GCP, ICH, GDPR, etc.).
  • Ensures project deliverables are met in accordance with contract, budget, and timelines.
  • Attends and presents adjudication services/processes at Investigator Meetings.
  • Serves as main point of contact for client and internal/external stakeholders regarding contracted event adjudication services.
  • Oversees all client communications.
  • Facilitates adjudication-specific project team meetings with relevant internal and external team members.
  • Ensures internal and external project team adjudication-specific training is completed and documented.
  • Leads, guides, and supports internal adjudication project team.
  • Leads in the development and maintains all adjudication-specific trial documentation and processes.
  • Provides feedback to senior management regarding project status, metrics, client satisfaction, and resourcing issues.
  • Develops and manages adjudication specific Project Plan.
  • Conducts Adjudication Committee Kick-off meeting.
  • Ensures translation vendor contracts are executed.
  • Ensures project files are in accordance with File Management Plan.
  • Provides coaching and mentoring to less experienced team members.
  • Participates in proposal development and bid defenses.
• Adjudication Process Management
  • Ensures adjudication processes are implemented in accordance with Charter and contracted scope of work.
  • Supports adjudication project team as needed.
  • Monitors event processing metrics, KPIs, turnaround times, and proactively implements process improvements.
  • Delivers adjudication reports/metrics to client and clinical project team.
  • Performs data reconciliation.
  • Monitors Adjudication Committee Member metrics and implements changes as necessary.
  • Implements quality control measures for adjudication processes and outcomes.
  • Follows up with sites as necessary for non-compliance.
  • Ensures all events have completed adjudication process.
  • Plays an active role in developing project management capability within team.
  • Participates in departmental initiatives, supporting best-practice while driving and implementing continuous improvement activities.
• Electronic Adjudication System Management
  • Ensures contract execution of third-party vendor, if applicable.
  • Manages development and maintenance of project-specific electronic adjudication system.
  • Facilitates review and finalization of Adjudication Configuration Specifications and Adjudication Report Specification.
  • Performs review of test database to ensure operational functionality in alignment with charter.
  • Facilitates incoming and outgoing test transfers.
  • Develops EAS System Acceptance and Release Notice.
  • Oversees User Account Management Activities.
  • Initiates change requests as needed.
  • Ensures database closeout.
• Risk Management
  • Develops Risk Management Plan in collaboration with client.
  • Identifies potential risks and proactively initiates mitigation strategy.
  • Consults with Adjudication Management as necessary.
• Financial Management
  • Accountable for financial performance across multiple complex projects or portfolios.
  • Ensures project profit margin is within target.
  • Completes revenue recognition, forecasting, and invoicing tasks in collaboration with finance.
  • Ensures third party vendors and Adjudication Committee members are compensated according to terms of their contracts.
  • Identifies out of scope tasks and proactively initiates change orders.
• Quality Management
  • Ensures compliance with all organizational, departmental, and project-specific procedures and training requirements.
  • Participates in internal, client, and regulatory audits.
• Other
  • Carries out any other reasonable duties as requested.

Qualifications

• Significant demonstrable professional experience in the same or similar role.
• Relevant clinical research industry experience.
• Solid demonstrable knowledge of medical terminology.
• Demonstrable knowledge of applicable global, regional, local clinical research regulatory requirements (i.e., GCP, ICH, GDPR).
• Experience using tools (e.g., MS Office) to effectively communicate progress to internal and external stakeholders.
• Bachelor’s Degree or local equivalent in medicine or science, or relevant clinical research work experience.
• Licensed nursing professional or similar medical/scientific certification.
• English: Fluent.

Benefits

• Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs).
• Paid time off policy including holidays and sick time.
• Internal growth and development programs & trainings.
• 401(k) program, life & accident insurance and disability insurance.

Company Description

Our mission is to shape the future of clinical research. With decades of experience and the brightest minds in the industry, we help the global biopharmaceutical industry bring new, advanced medical treatments to market, faster.

We seek to change the world, and with the support of our teams across the globe, we flourish together. At Perceptive, we are one team. We learn, grow and win together.