Genice Jacques

While at Accelsiors I have led a team of up to 10 CRAs to successfully initiate and conduct global projects across multiple clinical trial phases. Overseeing all clinical operations activities, including site selection, initiation, monitoring, and close-out. I have been added to multiple projects as a Rescue CTM, to successfully revitalize the trail conduct. Completing this by implementing new strategies and optimizing workflows, I was able to realign the timeline to meet our study metrics and clinical obligations

Which helped increase the project success rate

Key Responsibilities:

• Clinical Operations Oversight/ Leadership: Overseeing all clinical operations activities, including site selection, initiation, monitoring, and close-out
• Led and managed complex clinical trials, including Phase II, therapeutic areas, or study designs
• Team Management: Leading and managing the clinical team, including workload allocation, training, and performance evaluation
• Regulatory Compliance: Ensuring adherence to regulatory guidelines and company SOPs
• Risk Management: Identifying, assessing, and mitigating clinical risks
• Budget Management: Monitoring and managing clinical budgets
• Communication: Effective communication with internal and external stakeholders, including sponsors, investigators, and regulatory authorities
• Problem-solving: Identifying and resolving clinical issues and challenges
• Quality Assurance: Ensuring the quality and integrity of clinical data

Company Overview: Multiple Military Treatment Facilities Ft Sam Houston, Ft, Cavazos, Lackland Air Fours Base.

Successfully led the planning installation and execution of three temporary medical facility setups. This allowed the rapid deployment and operationalization of medical care and Clinical trial conduction for COVID-19 treatment and vaccines without impacting or adding additional burden to the already existing DHA-medical treatment facilities

• As a Sr Clinical Trials Manager- Program Lead, I managed and mentored a team of 43 diverse professionals. Provided strategic direction and operational oversight
• Collaborating with the Project Manager to set targets for clinical monitoring, staffing, and ensuring the conduction of trials were in compliance with project goals

Key Responsibilities:

• Clinical Operations Oversight/ Leadership: Overseeing all clinical operations activities, including site selection, initiation, monitoring, and close-out
• Led and managed complex clinical trials, including Phase II, therapeutic areas, or study designs
• Team Management: Leading and managing the clinical team, including workload allocation, training, and performance evaluation
• Regulatory Compliance: Ensuring adherence to regulatory guidelines and company SOPs
• Risk Management: Identifying, assessing, and mitigating clinical risks
• Budget Management: Monitoring and managing clinical budgets
• Communication: Effective communication with internal and external stakeholders, including sponsors, investigators, and regulatory authorities
• Problem-Solving: Identifying and resolving clinical issues and challenges
• Quality Assurance: Ensuring the quality and integrity of clinical data

• Company Overview: Join base San Antonio
• Facilitates clinical trials at DHA-operated medical treatment facilities in connection with CROs and pharmaceutical, device, and biotech companies presenting unique public-private partnership opportunities
• Collaborating with the Project Manager to set targets for clinical monitoring, staff, and ensuring the recording of trials in compliance with project goals
• Join base San Antonio
• Key Responsibilities:
• Clinical Operations: Developed and implemented study-specific clinical tools and documents
• Team Leadership: Coordinated and supervised cross-functional teams and provided project-specific training and led regular team meetings
• Regulatory Compliance: Ensured adherence to SOPs, local regulations, and international guidelines (CFR, ICH, GCP)
• Project Management: Developed and executed comprehensive project plans and timelines
• Stakeholder Management: Built and maintained strong relationships with stakeholders and vendors
• Organizational Agility: Successfully operated within a matrix organizational structure

• Key Responsibilities:
• Oversee the day-to-day function of the Research, nursing, and medical staff members of various clinics
• Develop and maintain the clinical trial deliverables including timelines, budgets, and resource requirements within a therapeutic area
• Attend and support the clinical sub team
• Provide matrix management of cross functional representatives to manage clinical execution deliverables
• Review and refine clinical operations plans for each study
• Manage CRO/vendors to achieve goals and ensures that performance expectations are met
• Participate in patient identification activities and the development of patient recruitment plans
• Identify, recruit, and approve clinical investigators in collaboration with Medical Monitor and Clinical Operations leadership
• Manage internal supporting staff to ensure that all activities are moving according to trial timeline(s)