Clinical Operations Manager

Tessera Therapeutics•Somerville, MA

About The Position

The Clinical Operations Manager will actively engage in day-to-day clinical trial management activities and lead the cross-functional study team. This role will contribute to the development and presentation of clinical trial operational strategy and updates to leadership. The manager will provide input into baseline budget development and management, timeline development and management, and identify outsourcing needs of the study. They will lead the team in the evaluation, selection, and management of global Contract Research Organizations (CROs) and other vendors. Responsibilities include reviewing, contributing to, and/or authoring study Protocol, Informed Consent Forms, Investigator Brochures, Clinical Study Reports, and Regulatory submission documents. The role involves conducting on-going trial risk identification and analysis, and developing risk-based mitigation strategies to maintain study deliverables. The Clinical Operations Manager will oversee, manage, and ensure clinical trial(s) are executed in compliance with key metrics, timelines, budget, operational and quality standards (ICH/GCP/SOPs). They will ensure CROs and Third Party Vendors perform in alignment with study plans and deliver per the scope of work. The role includes leading feasibility assessment to select relevant regions and countries for the study, overseeing and/or conducting site evaluation and selection, and liaising with clinical site staff and Investigators. The manager will lead the development of and oversee implementation of patient recruitment and retention strategies and act on any deviations from plan. They will oversee and provide input to the development of study specific documents, including site training materials, case report forms (CRF), statistical analysis plan, and other study plans and manuals. The role involves leading and/or participating in regular review of clinical trial data and metrics, including protocol deviations, to ensure timely identification and closure of data quality issues and non-compliance by sites. The manager will develop, monitor, and manage the budget for clinical trial(s) including proposals, contracts, and scope changes for study vendors. They will provide input to the study drug and clinical supplies forecasting and oversee drug accountability and drug reconciliation. The role requires escalating issues related to study conduct, quality, timelines, or budget to line management and other stakeholders, and developing and implementing appropriate actions to address issues. Ensuring inspection readiness through the study lifecycle, supporting internal audits and external inspection activities, and contributing to CAPAs as required are key responsibilities. The manager will oversee set-up and maintenance of study systems and documents by CRO, including Trial Master File (TMF), and manage and oversee study close-out activities including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability. Ensuring compliance with clinical trial registry requirements is also part of the role. The ideal candidate is an individual with excellent team management abilities, who will lead the cross-functional Clinical Study Team and be responsible for overall clinical study delivery. They will be the primary point of contact for leadership and oversight of the assigned study(ies). The candidate will have demonstrated ability to partner with and proactively manage internal stakeholders, CROs, and vendors, and collaborate cross-functionally to deliver global clinical trials according to the planned timelines and budget, while ensuring quality in accordance with ICH-GCP guidelines and regulatory requirements.

Requirements

Bachelor’s degree in a relevant scientific or healthcare discipline
8+ years of clinical operations experience
4+ years as a clinical trial manager
Experience leading cross-functional teams
Experience accountable for planning and executing global clinical trials
Experience in managing global clinical operations for first-in-human to Phase 3 Programs from start-up to close out
Experience managing clinical CRO and other vendors, budgets and timelines
In depth knowledge of ICH/GCP guidelines
Working knowledge of regulatory guidelines/directives
Proficiency in trial management systems, IVRS/IWRS, eTMF, EDC, SmartSheets and Microsoft applications including Project, PowerPoint, Word and Excel
Effective project management skills
Cross-functional team leadership skills
Organizational skills
Ability to thrive in a fast-paced environment
Demonstrated ability to prioritize and manage multiple competing tasks
Flexibility to adapt to changing program needs
Excellent team management abilities
Demonstrated ability to partner with and proactively manage internal stakeholders, CROs, and vendors
Ability to collaborate cross-functionally to deliver global clinical trials according to the planned timelines and budget, while ensuring quality in accordance with ICH-GCP guidelines and regulatory requirements

Nice To Haves

FDA and other regulatory inspection experience is a plus
Current rare disease experience and/or gene therapy experience is highly preferred

Responsibilities

Actively engage in day-to-day clinical trial management activities and lead the cross-functional study team
Contribute to the development and presentation of clinical trial operational strategy and updates to leadership
Provide input into baseline budget development and management, timeline development and management
Identify outsourcing needs of the study and lead the team in the evaluation, selection and management of global Contract Research Organizations (CROs) and other vendors
Review, contribute to and/or author study Protocol, Informed Consent Forms, Investigator Brochures, Clinical Study Reports and Regulatory submission documents
Conduct on-going trial risk identification and analysis, and develop risk-based mitigation strategies in order to maintain study deliverables
Oversee, manage and ensure clinical trial(s) are executed in compliance with key metrics, timelines, budget, operational and quality standards (ICH/GCP/SOPs)
Oversee and ensure the CROs and Third Party Vendors are performing in alignment with study plans and are delivering per the scope of work
Lead the feasibility assessment to select relevant regions and countries for the study.
Oversee and/or conduct site evaluation and selection, and liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships
Lead the development of and oversee implementation of patient recruitment and retention strategies and act on any deviations from plan
Oversee and provide input to the development of study specific documents, including site training materials, case report forms (CRF), statistical analysis plan, and other study plans and manuals
Lead and/or participate in regular review of clinical trial data and metrics, including protocol deviations, to ensure timely identification and closure of data quality issues and non-compliance by sites
Develop, monitor and manage budget for clinical trial(s) including proposals, contracts, and scope changes for study vendors
Provide input to the study drug and clinical supplies forecasting and oversee drug accountability and drug reconciliation
Escalate issues related to study conduct, quality, timelines or budget to line management and other stakeholders and develop and implement appropriate actions to address issues
Ensure inspection readiness through the study lifecycle and support internal audits and external inspection activities and contribute to CAPAs as required
Oversee set-up and maintenance of study systems and documents by CRO, including Trial Master File (TMF)
Manage and oversee study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
Ensure compliance with the clinical trial registry requirements