Senior Project Manager, Clinical Adjudication at CALYX · Massachus…

Senior Project Manager, Clinical Adjudication Location: US MA Decentralized About Perceptive 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. Are you ready to help change the world? Apart from job satisfaction, we can offer you: HEALTH: - Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs) YOURSELF: - Paid time off policy including holidays and sick time - Internal growth and development programs & trainings WEALTH: 401(k) program, life & accident insurance and disability insurance About the role 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, including identifying systemic risks, improvement opportunities, and capacity or capability gaps 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, in accordance with contracted scope. 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, including agenda and minutes. 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 of and maintains all adjudication-specific trial documentation and processes (including Adjudication Charter, Adjudication Procedure Manual, Adjudication Site Manual, Adjudication Committee Manual, Data Transfer Specifications, Adjudication Configuration Specifications, Adjudication Report Specifications, File Management Plan, Communication Plan, Risk Management Plan, etc.). 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 as necessary. Delivers adjudication reports/metrics to client and clinical project team. Performs data reconciliation. Monitors Adjudication Committee Member metrics are in accordance with Charter and implements changes as necessary. Implements quality control measures for adjudication processes and outcomes as necessary. 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 through coaching and mentoring less experienced team members, contributing to training, interviews and onboarding. 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, in collaboration with electronic adjudication system vendor. 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. Facilitate 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, including proactive margin management, forecasting accuracy, recovery planning, and commercial risk mitigation.   Proactively implementing steps to correct as needed, providing insight and recommendations to business with support from Adjudication Management where needed. 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. Functional Competencies (Technical knowledge/Skills) Proactively leads medium to high complexity projects/clinical adjudication processes with a high degree of autonomy, setting direction for planning, execution and delivery across multiple workstreams. Provides delivery leadership across cross-functional and global teams, driving alignment, accountability. Demonstrates exceptional interpersonal, verbal and written communication skills, tailoring messaging for executive stakeholders, clients, technical teams and global partners. Shows agility and adaptability in managing changing priorities, new information, and evolving project needs, while maintaining composure and effectiveness. Manages multiple tasks and concurrent projects, applying strong prioritization,  organizational skills and advanced judgement to maintain accuracy, quality, and momentum. Applies advanced critical thinking and analytical skills to anticipate issues, assess risks, evaluate options, and implement robust solutions with some oversight. Demonstrates strong proficiency with Microsoft 365 (Word, Excel, PowerPoint) and project-related systems, using tools effectively for analysis, tracking, reporting and communication. Maintains an in‑depth understanding of Perceptive technologies and imaging processes, using this knowledge to guide decision‑making, troubleshoot challenges, and support client expectations. Highly organized, detail‑driven, and systematic, ensuring documentation, governance, and delivery standards are consistently met or exceeded. Takes proactive ownership of tasks and project deliverables, and drives them to completion, escalating early and proposing solutions where risks or blockers emerge. Leads others through change by anticipating impacts, setting clear expectations, and maintaining delivery performance during shifting conditions. Efficiently structures, prioritizes and delegates work effectively across competing demands, ensuring deadlines are met or exceeded without compromising quality. Applies sound judgment, influences stakeholders in decision‑making, weighing risks, data, stakeholder impacts, and business context to make timely and informed choices. Demonstrates commitment to continuous improvement and learning, staying current on imaging, project management practices and industry trends, and sharing knowledge with peers. Thrives in a high-pressure, time-sensitive environment, providing calm leadership, clear escalation, and disciplined execution during peak operational periods. Experience, Education, and Certifications Significant demonstrable professional experience in the same or similar role demonstrating capability in managing scale, complexity and organizational impact beyond single-project delivery, with experience coaching others. 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. This role is remote based. The annual base salary range for this role is $84,000- $120,000.  This range represents the anticipated initial annual salary and will vary depending on several factors including the candidate’s experience and skills as well as market rate adjustment. le is remote.  Candidates located in the following states: AZ, CT, DE, FL, GA, IL, MA, MO, NH, NJ, NC, PA, UT, VA are preferred. Come as you are. We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.