Benjamin Flagg Email & Phone Number

Boston, Ma, Us

Boston, Ma, Us

• Provide scientific, clinical, and operational input to early clinical development programs, with an emphasis on protocol-specific activities• Serve cross-functional study teams for the design, execution, and medical monitoring of clinical trials• Assist with data interpretation and communication by interfacing directly with other functions (including Clinical Development, Global Clinical Operations, Medical Writing, Biometrics, Patient Safety, Medical Affairs, Clinical Pharmacology and Biomarkers, and Regulatory Affairs) to support the development of novel therapeutics for Type 1 Diabetes.

Boston, Ma, Us

• Project manage Phase I through Phase IV clinical trials from Start-Up to sNDA submission respectively• Collaborate with Study Execution Team to manage MS Project timeline and to meet study timeline deliverables • Train the CRO/CRU teams, investigators, and staff as needed regarding protocol and assigned logistics of the clinical trial• Manage multiple FIH trials concurrently • Review clinical study data prior to dose escalation and Clinical Study Report• Assist leadership of Phase 1 Center of Excellence in strategic initiatives and program management• Management of vendors responsible for safety laboratory services, ECG monitoring, site payments, and IWRS• Site management including review of monitoring reports, EDC metrics, tracking of site visits, and communication with monitor and sites• Perform process review and improvement initiatives of study plans, WIs and SOPs• Develop and finalize study plans used by the Sites, CRO/CRU and Vertex• eTMF QC, auditing, reconciliation, archiving and maintaining inspection ready quality at all times. • Maintain study trackers for site activation/enrollment (actuals and baseline/forecast), document version control, action/decision/issue log, CTMS key study milestones, and protocol deviation log

Boston, Massachusetts, Us

• Member of a comprehensive clinical research team managing multiple diabetes and cardiometabolic focused research projects • Led interdepartmental ICH/GCP training sessions and assisted in protocol feasibility evaluation with Principal Investigator • Performed clinical laboratory procedures, coordinated patient recruitment, facilitated sponsors’ regulatory and initiation visits• Maintained research subjects records, regulatory binders, compliance documents, monitored safety reports and provided ad hoc statistical analysis for PIs. • Project manager for a Phase III (IND) multicenter clinical trial testing the effectiveness of allopurinol in preventing kidney function loss in diabetes• Led study initiation trainings for new research sites on study protocol, systems operations on-site and during Investigator Meetings.• Interviewed and examined patients in the clinic communicating the essence and implication of involvement in a clinical trial• Conducted clinical study assessments including vital signs, ECG traces, Ankle-Brachial Index, and phlebotomy. • Recorded and managed data in electronic databases, regulatory binder and properly monitored patient health and compliance according to Good Clinical Practice (GCP) guidelines and IRB protocols.

Boston, Ma, Us

Facilitated and managed multiple online patient and provider communities to achieve high-quality deliverables and actionable insights for healthcare and pharmaceutical clients. Supported storytelling and reporting by providing qualitative data analysis, managing aggregate data, and leveraging multiple research methodologies. Developed and sustained excellent relationships with multiple clients

• Assisted veterinarians through preliminary examination, surgery support, x-ray radiography, phlebotomy, gathering patient history, managing invoices, and fundamental veterinary care for a busy, domestic small animal practice• Oversaw in-house pharmacy operations, cytology laboratory, vaccine preparation, kennel procedures, and client services staff

East Falmouth, Ma, Us

• Seasonal biomedical laboratory technician responsible for Atlantic horseshoe crab (Limulus polyphemus) blood serum isolation processing• Worked on a team of technicians collaborating through various techniques to manufacture Limulus Amebocyte Lysate (LAL) products used to screen and quantify gram-negative bacterial endotoxins and (1→3)-β-d-glucans

St. Petersburg, Florida, Us

• Aided Professor in laboratory demonstrations, preparations, and administering practicums• Assisted students in laboratory techniques, protocols, dissections, computing phylogenetic data programs, and tutoring

St. Petersburg, Florida, Us

• Oversaw 32 students and served a professional presence in upperclassman housing• Provided counseling support, community event planning, and a reference to campus resources• Met weekly with 53 RAs and college officials to collaborate on campus life and security

St. Petersburg, Florida, Us

• Served on a board responsible for reviewing and designating judicial sanctions of accused student offenders breaking Eckerd College policies• Served on various conduct review committees with Eckerd College faculty and staff to review more serious student offenders.

St. Petersburg, Florida, Us

• Responsible for marine equipment check-out procedures, liability release, and retail processes• Managed, trained, and scheduled staff of 20 student employees for three years.• Led, planned, and facilitated campus events for students

Bachelor Of Science (B.S.), Biology And Spanish, Chemistry Minor

Spanish Language And Culture

Education record