In this role, Deb is responsible for the operational oversight of clinical studies sponsored by Inventiva. She provides direction within the Clinical Operations department while managing and developing Clinical Operations staff members. She is accountable for all operational aspects of the assigned clinical studies, including allocation of resources and delivery of the study on time, within budget and scope, and in compliance with applicable regulatory and quality standards.

Devises efficient, effective clinical trial execution strategies; informs planning and monitors execution of clinical studies, including management of study budgets / timelines and external vendor(s) management.Regularly interacts with Clinical, Medical, Regulatory on matters concerning clinical development status.Efficient at clinical trial timeline and budget forecasting, using objective measures and tools to plan and communicate key clinical trial metrics.Exceptional planning, communication, and creative problem-solving skills, ensuring trial delivery for one or more clinical trials.Assists with development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations.Integrates best practices as appropriate.

Management of monitoring operations.Develop and implement clinical operations strategies across clinical programs.Establish best practices for Clinical Operations.Management of Clinical Operations personnel.Responsible and accountable for the for the day-to-day oversight of all clinical technical and operational activities.Provide leadership, project management, program oversight, and mentorship to Clinical Operations teams and activities ensuring activities are performed in accordance with CFR, EMA, and ICH-GCP regulations.

Management of Clinical Operations personnel.Responsible and accountable for the conduct of clinical trials.Responsible for the implementation and maintenance of clinical systems.

Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.Participates in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process. Conducts onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.Ensures that staff has the proper materials, systems access and training to complete job responsibilities. Provides oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.Participates in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training.Manages the quality of assigned staff's clinical work through regular review and evaluation of work product.Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.May fill in as a CRA or CRS for a defined project or to assist with milestone achievement on a temporary basis.Participates in clinical operations quality or process initiatives.

Oversee the delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables.Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.Develop, implement and maintain the Site Recruitment, SPS Operations and SPS Risk Management Plan within the agreed project strategy.Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to appropriate SPS management and project management leaders.Act as the first line of escalation for site management questions and issues on assigned projects.Lead preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).Develop and deliver presentations/training to clients, colleagues and professional bodies, as required.Participate in business development activities such as proposal development and bid defenses.May conduct co-monitoring and/or assessment visits as needed to ensure the study is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.

• Lead study start-up activities (i.e., site recruitment, regulatory document collection, IRB submission) including the review of clinical and project-related documents. • Serve as a clinical resource for sites, Project Managers, Clinical Data Managers, contract Clinical Research Associates, and other Outcome staff for project-related inquiries and issues; conduct initial and ongoing site, sponsor, and project staff training as necessary.• Participate regularly in client calls; provide updates on study reports (site, enrollment, regulatory document, query, monitoring status, etc.); assist the client in problem solving and provide consultation on study-related activities where applicable.• Manage and track study progress on recruitment/site selection, site readiness, IRB/EC submissions, patient enrollment, etc.• Understand and contribute to EDC specification, database requirements, customizations, queries/form controls.• Independently conduct all types of monitor visits, including but not limited to qualifying site assessments, initiation, interim, and closeout to monitor study progress and assure compliance with protocol-requirements, applicable regulations and ICH/GCP; ensure Investigator Site File is up to date; assist site with IRB/EC submissions; generate monitoring visit reports, confirmation and follow-up letters; identify and solve or escalate problems/issues where appropriate.• Participate in remote monitoring and data quality audits.• For select studies, act as Lead CRA by coordinating resources, trainings, and CRA activities.• Mentor and train less experienced Clinical Study Assistants and less experienced CRAs.• Participate in site contract negotiation and budgeting.• Participate in financial budget management, bid defense meetings, and formulating strategic solutions to ensure study success (i.e. contingency plans recruitment strategies patient retention strategies, site/patient incentives, collaborate/interact with KOLs).

• Lead study start-up activities (i.e., site recruitment, regulatory document collection, IRB submission) including the review of clinical and project-related documents. • Serve as a clinical resource for sites, Project Managers, Clinical Data Managers, contract Clinical Research Associates, and other Outcome staff for project-related inquiries and issues; conduct initial and ongoing site, sponsor, and project staff training as necessary.• Participate regularly in client calls; provide updates on study reports (site, enrollment, regulatory document, query, monitoring status, etc.); assist the client in problem solving and provide consultation on study-related activities where applicable.• Manage and track study progress on recruitment/site selection, site readiness, IRB/EC submissions, patient enrollment, etc.• Understand and contribute to EDC specification, database requirements, customizations, queries/form controls.• Independently conduct all types of monitor visits, including but not limited to qualifying site assessments, initiation, interim, and closeout to monitor study progress and assure compliance with protocol-requirements, applicable regulations and ICH/GCP; ensure Investigator Site File is up to date; assist site with IRB/EC submissions; generate monitoring visit reports, confirmation and follow-up letters; identify and solve or escalate problems/issues where appropriate.• Participate in remote monitoring and data quality audits.• For select studies, act as Lead CRA by coordinating resources, trainings, and CRA activities.• Mentor and train less experienced Clinical Study Assistants and less experienced CRAs.• Participate in site contract negotiation and budgeting.• Participate in financial budget management, bid defense meetings, and formulating strategic solutions to ensure study success (i.e. contingency plans recruitment strategies patient retention strategies, site/patient incentives, collaborate/interact with KOLs).

• Participate in writing and reviewing phase I, II, and III protocols.• Assist in selecting sites and vendors for participation in clinical trials sponsored by biotech and pharmaceutical companies.• Create training and educational materials for physicians and patients.• Collaborate in creating databases for clinical data and patient demographics.• Prepare data monitoring committee charter, monitoring plan, communication plan, case report forms and completion guidelines, and other supporting documents for clinical trial studies.• Develop innovative patient recruitment strategies.• Train and assist sites in collection of quality data.• Evaluate data quality and compliance at sites participating in industry-sponsored clinical trials. • Support Program Director in quality assurance reviews.• Build and maintain lines of communication between study sites, sponsors, vendors, CROs and other study personnel.• Conduct study-specific training at sites.• Assist with preparation of clinical/statistical study reports and patient registration/randomization • Prepare progress reports for clients in regards to accrual, patient demographics, data trends, data accuracy, and site and patient compliance to the protocol.• Prepare materials and assist in the planning, coordination, and organization of CRA meetings, CRA teleconferences, and Investigator Meetings.• Assist in the creation of Investigator Manuals, CRA Training materials, Investigator Meeting materials, and data tracking systems for clinical studies.• Review regulatory documents for proper completion.• Track monitoring visits, visit reports and expense reports.• Maintain regular contact with study site to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests.

• Provide Partners Worldwide representation and services in the Northeastern geographical region of the United States.• Promote and manage Partners Worldwide partnerships in Africa and Eastern Europe.• Develop and implement management information systems for entire organization.

• Oversee all research data management and regulatory needs of the organization.• Work with study doctors on developing investigator-driven protocols.• Act as a liaison between sponsor companies and investigators.• Prepare projects for grant submissions.• Oversee project from development phase to study completion.• Work with team on phase I through phase IV protocols.• Provide QA for satellite sites.• • Manage all aspects of conducting clinical trials, work with hospitals, community health center, and physician’s offices bringing clinical research to communities and enrolling their patients in CRI HIV/AIDS research studies.• Be responsible for site-specific and study-specific duties in enrollment. • Act as liaison between the investigators, primary care providers, the New England Institutional Review Board (NEIRB), and the sponsor.• Screen, enroll, and follow study subjects along with the investigator, ensuring protocol compliance and close monitoring while the subjects are on study.• Have responsibility of all data and source documentation, adverse incident reporting, and maintenance of complete regulatory files.• Facilitate internal and external Institutional Review Board (IRB) submissions by preparing documents and related correspondence, and maintain regulatory files.• Respond to requests for modifications, clarification, and renewal of regulatory documents.• Oversee research department’s regulatory files and assist in various logistical functions for department activities.