Daniel Larson Email & Phone Number

Marlborough, MA, US

Boston, Massachusetts, US

Boston, Massachusetts, US

Clinical Development Operations support

Waltham, Massachusetts, US

Waltham, Massachusetts, US

Maynard, MA, US

• Design, implement, and maintain post-marketing, decentralized, real-world evidence clinical trial platform
• Develop specialty pharmacy work flows for patient recruitment
• Provide strategic guidance for next-generation software platform
• Responsible for protocol and GCP adherence during study conduct
• Develop and manage study plan and recruitment forecast to ensure that milestones are achieved on schedule
• Oversee subcontracting of ancillary services (e.g. patient recruitment sites, CROs, etc.)

Waltham, MA, US

• Responsibilities included overseeing conduct of multiple clinical studies for one or more drug program
• Managed relationship of pharmaceutical partner and provided strategic guidance on clinical study execution
• Revised clinical operations and regulatory Standard Operating Procedures (SOPs), Work Instructions (WIs), forms and templates

Waltham, Massachusetts, US

• Implemented a scalable clinical operations outsourcing model based on vendor core competencies with an integrated risk mitigation strategy
• Successfully rescued a Phase 1 first-in-human oncology study that was failing to enroll patients
• Advanced clinical development of two drugs while simultaneously initiating a first-in-human study in another drug
• Refined and executed complex biomarker strategy involving the processing of tissue, whole blood, and plasma samples at multiple labs for multiple drug programs
• Supported operational aspects of international studies including country-specific import licensing, regulatory submission, patient privacy, and safety reporting requirements
• Directed and managed cross-functional teams in the planning and execution of clinical trials from start-up through close-out

US

• Managed complex, randomized, multicenter, double-blind, placebo-controlled Phase II study for novel cell therapy addressing acute kidney injury occurring in cardiac surgery patients post cardiopulmonary bypass using.
• Supported fully-outsourced study utilizing vendors for data management, statistics, site monitoring, safety, drug distribution, and in-home nursing for a study population that was transitioned from in-patient to.

• Oversaw all aspects of clinical trial conduct for a cutting-edge radiopharmaceutical diagnostic and therapeutic compound for the treatment of pheochromocytoma / paraganglioma
• Provided general strategic support for all ongoing clinical studies with focuses on vendor management, risk analysis, and data management

• Managed all aspects of day to day operations for two studies: o Phase III study for activated macrophage solution for the treatment of chronic diabetic wounds o Pivotal study for combination device / biologic product.
• Functioned as primary sponsor study contact for all study-related activities, and accountable for internal departmental study leads' performance
• Responsible for ensuring the quality of clinical projects, and that they were conducted according to ICH/GCP, Averion and/or Sponsor SOPs, guidelines, and requirements
• Collaborated on the management of site monitoring, database development and maintenance, data management and entry, programming, safety, statistics, report writing, and agency presentations
• Authored and reviewed study documents to ensure quality standards were met (e.g. Protocol, Case Report Forms, Monitoring Plan, Data Management Plan)
• Proactively identified issues and developed solutions for assuring study timelines and budgets were met without compromising quality deliverables

• Oversaw internal and external project activities including project timelines and budgets, to ensure study execution was in accordance with regulations, GCP, and corporate standards
• Managed vendors, investigative sites, senior management deliverables, cross-departmental clinical communications
• Coordinated and communicated project activities; produced project status reports; conducted project meetings
• Reviewed vendor requests for proposals, scopes of work, budgets, and operating procedures
• Directed investigator recruitment and selection; conducted investigator and site staff training
• Managed reporting of serious adverse events to safety medical monitor and to regulatory agencies

Cambridge, MA, US

• Managed all aspects of in-house clinical trials, including oversight the activities of medical writing, clinical data management, biostatistics, drug supply, regulatory, independent contract site monitors, central.
• Collaborated with the medical director and biostatistician to design clinical trials that were in alignment with the clinical development plan and that maximized a study’s potential
• Assessed feasibility of clinical sites (e.g. design, size, location, site staff experience, and patient population) to determine probability of success in clinical trial participation
• Ensured clinical trial conduct was in compliance with good clinical practice, country-specific regulations, and corporate standard operating procedures
• Reviewed all vendor requests for proposals, scopes of work, budgets, and operating procedures
• Led periodic reviews of study data to ensure that the correct patients were recruited, data trends were detected, and study objectives were met

Cambridge, MA, US

• Conducted site visits, including site qualification, initiation, monitoring, and close-out
• Performed site training, source data verification, study drug accountability, regulatory binder review, and assisted in data query management
• Co-monitored with contract monitors to ensure their quality and compliance

Cambridge, MA, US

• Acted as lead clinical data manager on multiple studies concurrently, performing all data management functions from study start-up to close-out, including developing data management plans, designing case report forms.
• Managed all data management activities performed by contract research organizations and external vendors supplying data, including negotiating scopes of work, budgets, and timelines
• Played a key role in the implementation of electronic data capture technology, and spear-headed process and documentation improvements associated with the system

Waltham, MA, US

• Designed electronic case report forms, specified edit checks, developed validation plans and test data, annotated electronic case report forms, specified mappings for sponsor specific data tables, converted protocols.
• Simultaneously managed multiple sponsors and trials in various life-cycle stages, including study start-up, change-orders, and study close-out, and assisted sponsors in creating new work-flows associated with the.
• Solely responsible for implementation of new patient diary technology, including the creation of specifications, work-flow, and validation processes

Durham, North Carolina, US

• Performed all data management functions from study start-up to close-out, including designing case report forms, authoring case report form guidelines, specifying edit checks, designing data entry databases in SAS.
• Managed data management timelines and budgets, acted as principal data management contact for sponsors, collaborated with internal clinical operations and statistical teams in the execution of studies
• Trained and mentored new hires, authored new work instructions and standard operating procedures, developed and implemented new technologies

Bachelor Of Science, Biomedical Laboratory And Clinical Sciences (Summa Cum Laude)

Ecology & Evolutionary Biology

Engineering

Education record