Clinical Operations

• manage the implementation and installation of diagnostic instrumentation portfolio
• coordinate with laboratory customers, hospital facilities teams, IT stakeholders
• provide quality implementations with updates to Project Teams and Stakeholders
• act as the single point of contact between the customer and BCI
• maintain all project related documentation

Project Manager, Clinical Lab Equipment Installation

• Supports back of house operations and store maintenance
• Contribute to supporting the service experience, visual processes, and daily business operations
• Leads by example in cultivating Terrain’s four promises
• Delivers a seamless, multi-channel shopping experience
• Participates in supporting visual priorities, facility standards
• Maintains organizational standards in the back of house
• Supports team development with new hire onboarding
• Provides timely and specific employee feedback
• Leads daily product flow processes
• Guides the operational support associates

Terrain Assistant Manager – Site Operations

• Provide global leadership for the planning, set up, execution, oversight, and delivery of complex oncology clinical trials from First in Human (FIH) through late phase Ph2/3 registration studies and submission.
• Lead the end to end execution of global Phase I–III oncology studies, including FIH and registration enabling trials, from startup through closeout, to ensure the study is delivered within timelines, budget and with high quality.
• Provide hands-on project leadership in a global, cross-functional setting, including study timelines projection, protocol development support, site selection/activation, vendor management, timeline/budget oversight, risk/issue resolution, and CRO performance management.
• Plan, drive and oversee study start up, site activation, enrollment strategy, patient retention, data quality oversight, database readiness, study reporting and CSR delivery aligned with regulatory strategy submission plans.
• Ensure rigorous vendor oversight, particularly CRO performance (monitoring, data management, labs, imaging, ePRO, etc.).
• Proactively identify operational risks and implement robust mitigation plans. Escalate critical issues and propose solutions to senior leadership.
• Plan and manage study timelines, project site activation, recruitment and readout timelines, including building various scenarios depending on data-driven study outcome assumptions and other requirements.
• Manage clinical trial budgets, forecasting, accruals, and change orders.
• Ensure adherence to ICH GCP, local/global regulations, SOPs, and audit readiness, including respond to audits/inspections, and coordinate CAPA implementation, as needed.
• Partner closely with internal and external stakeholders to deliver integrated milestones.
• Chair global study team meetings, drive team collaboration and ensure clear decision making and documentation.
• Build strong relationships with investigators, global KOLs, and academic partners as required.

Clinical Study Delivery Lead, Global Clinical Operations, Oncology

• Provide global oversight for significant portion of EO clinical portfolio, guiding project planning, operational delivery, and resource allocation to Global and Clinical Project Teams (GPTs/CPTs)
• Champion the deployment and integration of artificial intelligence, digital tools, and process automation across all clinical operations
• Consistently embrace novel operational models, platform studies, and customized strategies for complex modalities
• Anticipate and address emerging regulatory requirements by embedding compliance into operational strategy
• Foster strong cross-functional and external partnerships, engaging with Tumour Councils and industry thought leaders
• Build, inspire, and mentor high-performing, diverse teams
• Establish and refine operational frameworks, leveraging AI and analytics to monitor performance
• Lead strategic vendor engagement and procurement, ensuring effective collaboration with key delivery partners
• Set and uphold target metrics for clinical quality, overseeing compliance and process improvement initiatives

Executive Director, Clinical Development Operations – Early Oncology

• Leading and executing complex clinical trial contracts and budget negotiations with investigative sites, CROs and vendors
• Partnering with Clinical Operations leadership to develop and deliver contracting and budgeting strategies across programs and portfolios
• Providing strategic input into study feasibility, start-up planning, and early budget development
• Ensuring contracts and budgets comply with company policies, regulatory standards, and regional requirements
• Collaborating closely with Clinical Operations, Finance, Legal, and study teams to drive timely execution and approvals
• Identifying financial, operational and regional risks and proactively proposing mitigation strategies
• Tracking contract and budget performance, reporting trends and key metrics
• Driving continuous improvement initiatives to enhance efficiency, consistency, and best practices
• Acting as a subject matter expert on contract templates, budget models, and industry standards

Senior Specialist, Clinical Operations – Contracting & Budgeting

• Serve as an integral part of the Clinical Operations core team to drive operations efficiently including generating integrated project plans, identifying and tracking key project milestones and metrics, and monitoring budgets, invoices, and accruals.
• Provide cross-functional transparency of the clinical trial(s) progress to ensure team is efficiently progressing forward with deliverables, including deliverables from CRO and other partners.
• Organize internal and external meetings (development of agendas, minutes, and presentations)
• Manage ancillary supplies for clinical trials
• Support risk management including risk assessment, mitigation planning, and internal and external audit preparation and follow-up
• Contribute to development of clinical study plans and manuals, including version tracking and team training.
• Provide support to senior leadership in defining the deliverables on the clinical trial(s) which coincide with the expectations defined in the departmental and company goals.
• Maintain ongoing communication with team members and all stakeholders including senior leadership and external partners or vendors.
• Foster a sense of inclusion and create a shared sense of purpose.

Senior Project Manager, Clinical Operations

• Serve as business lead for one or more systems owned by Clinical Operations. Provide business support for multiple systems and applications used by Clinical operations.
• Work closely with the business owner/lead, IT systems owner/team, and relevant vendor partners. Contribute to or lead vendor management, where appropriate, dependent on owning department for vendor relationship.
• Work closely with business stakeholders inside and outside of Clinical Operations, where applicable, to understand current processes, needs, gaps, and value potential. Draft business requirements that are clear and actionable by IT/vendor partners.
• Oversee business requirements to successful implementation, including communication to IT/vendor partners and business stakeholders, perform business testing, develop processes/trainings, and where needed, refine requirements.
• Oversee use and accuracy post go-live by monitoring data/metrics, hosting office hours, and managing user inquiries (mailbox). Utilize a proactive approach to assessing accuracy, troubleshooting, and seeking user feedback.
• Maintain a repository of standard terms, definitions, and calculations utilized in respective systems (the “lexicon”). Collaborate with stakeholders on business needs, create a common understanding, and build alignment across systems.
• Serve as a system Subject Matter Expert (SME) and provide support to users and teams on various use cases. This could include providing initial training or guidance ahead of an activity; providing routine support throughout an activity; assisting in vendor management for a subset of data-focused activities or of a vendor-owned system; or, where appropriate, leading the business team on a particular activity e.g., a one-time deep-dive analysis.
• Support department-level system, data or process needs for Clinical Operations. This will include, but not limited to, management of the department SharePoint page and support on the clinical trials mailbox.
• Support Core Capabilities and broader Clinical Operations team members on system and data-related needs. This could include SME support for a particular system, compilation of information, or broader input from the system/data/process perspective based on expertise.
• Support/manage process improvement efforts, ensuring adherence to BRT standards, and all applicable regulations and guidelines.
• Review/develop business terms, BRT Working Practices, Standard Operating Procedures (SOPs), templates, training, platforms and systems to drive improvements that are advantageous to BRT.
• Represent values-based leadership consistent with BRT Core Values: courage, urgency, integrity and community.

Senior Manager, Systems and Metrics – Clinical Operations

• Provide strategic input into the global development plan
• Direct, supervise and manage all operational aspects of global clinical projects
• Ensure quality deliverables on time and within budget
• Lead large, complicated program development and/or multiple programs simultaneously
• Teach, coach and mentor direct reports

Clinical Operations Project Lead

• Provides strategic and operational leadership for one or more complex clinical studies, ensuring successful delivery through the study lifecycle (planning to execution) ensuring adherence to timelines, budgets, and quality standards.
• Develops executable study plans and milestones. Establishes and maintains clinical study timelines.
• Utilizes operational data and metrics to drive high-quality planning processes and operational execution. Monitors the same to drive overall performance and risk management.
• Maintains a comprehensive overview of study status, proactively communicating progress, risks, and mitigation strategies to stakeholders.
• Leads/partners in the development and/or QC review of key study documentation (e.g, study protocols, informed consents, monitoring plans, operational manuals)
• Drives operational initiatives key to successful study execution including but not limited to site identification/qualification, site activation strategy, site performance management, overall enrollment success (including mitigation/rescue actions as needed).
• Ensures clinical activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines and internal quality standards.
• Supports or leads aspects of audit and inspection readiness and risk mitigation initiatives, including root cause analysis and CAPA development/closure for operational findings on assigned studies.
• Actively contributes to the advancement of department and organizational initiatives and processes.
• Leads study and/or project team(s), including effectively partnering with colleagues from other disciplines. (Clinical Development, Regulatory, Data Management, Safety, Quality) and external partners (CROs, vendors, academic collaborators, alliance partners) to ensure seamless trial execution.
• Participate in the mentorship of clinical operations staff.
• Contributes to the development and implementation of novel clinical operations activities and methods in cell therapy.

Clinical Operations jobs in Massachusetts

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