Clinical Operations Manager

Tessera Therapeutics•Somerville, MA

7h•$164,000 - $199,000

About The Position

The Clinical Operations Manager will lead the cross-functional Clinical Study Team and be responsible for overall clinical study delivery. This role serves as the primary point of contact for leadership and oversight of the assigned study(ies). The individual will partner with and proactively manage internal stakeholders, CROs, and vendors, and collaborate cross-functionally to deliver global clinical trials according to planned timelines and budget, while ensuring quality in accordance with ICH-GCP guidelines and regulatory requirements. Tessera employees are creative and collaborative problem solvers with a strong sense of integrity and unwavering commitment to scientific excellence.

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

Nice To Haves

FDA and other regulatory inspection experience
Current rare disease experience
Gene therapy experience

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