Chris Bertz Email & Phone Number

Bedford, Ma, Us

Bedford, Ma, Us

Bedford, Ma, Us

Provide independent consulting services for clinical trial project management and clinical operations activities.

Morrisville, Nc, Us

Foster City, Ca, Us

-Provide guidance and oversight for the successful management of all aspects of international hepatitis B and C clinical trials within designated program budgets and timelines. -Responsible for development and monitoring of study budgets and timelines. -Partner with functional peers to manage, adjust, and revise project timelines/budgets as necessary. -Successfully develop, implement, and complete clinical trials. -Develops RFPs, select CROs/vendors, and manages external resources. -Communicates project status and issues and ensure project team goals are met. -Participates in development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, and safety documents. -Manage direct reports and support their professional development. -Participate in training of Project Assistants and Clinical Research Associates.

-Provide project oversight of all study activities for migraine (phases I and II), neuropathic pain (PHN; phase II), and schizophrenia (phase II).-Coordinate internal/vendor activities (centralized laboratory, centralized ECG, data management, drug supplier, and other study supplies).-Provide oversight of site monitoring, regulatory file maintenance.-Provide oversight of site recruitment, training, and ongoing performance.-Conduct vendor selection.-Assist in the development of protocols, informed consent documents, and case report forms.-Lead training for study investigator meetings.-Lead globalization initiative of common document handling processes (both paper and electronic).-Assist in the integration of legacy company processes with a focus on SOP development and harmonization.

-Coordinate all monitoring activities and reporting for multi-study projects.-Draft monitoring plans, staff, and train all monitoring staff to project procedures.-Coordinate site regulatory oversight for multi-study projects including master regulatory files, INDs, certificates of confidentiality, etc.-Provide monthly summary of all quality assurance issues across all ongoing trials to the Sponsor.-Coordinate medical monitor SAE review and reporting to regulatory bodies.-Coordinate DSMB reporting activities related to safety and site study conduct.-Provide expertise to protocol development teams for protocol document development, manual of procedures development, CRF development, drug accountability plans, source documentation requirements, and training needs.-Provide training to study investigators and site staff in trial conduct.-Draft project SOPs.-Develop new business proposals and budgets and contribute to negotiation of new contracts.

-Coordinate all monitoring activities and reporting for multi-study projects.-Draft monitoring plans, staff, and train all monitoring staff to project procedures.-Coordinate site regulatory oversight for multi-study projects including master regulatory files, INDs, certificates of confidentiality, etc.-Provide monthly summary of all quality assurance issues across all ongoing trials to the Sponsor.-Coordinate medical monitor SAE review and reporting to regulatory bodies.-Coordinate DSMB reporting activities related to safety and site study conduct.-Provide expertise to protocol development teams for protocol document development, manual of procedures development, CRF development, drug accountability plans, source documentation requirements, and training needs.-Provide training to study investigators and site staff in trial conduct.-Draft project SOPs.-Develop new business proposals and budgets and contribute to negotiation of new contracts.

-Performed study initiation, interim monitoring, and study termination visits.-Provided reports of study visits to sponsors and site staff.Developed a generic site visit report template for multi-project use.-Performed Pharmacy Audits.-Provided support to study sites for all regulatory and clinical issues.-Performed internal quality control audits of study files.-Prepared investigator meeting presentations and training sessions.-Assisted in protocol and informed consent development.Completed preparation of IND initial and subsequent informational and safety submissions.-Completed preparation of NIH Recombinant DNA Activities Committee (RAC) initial and annual review submissions.-Developed both paper and electronic Case Report Forms (EDC).-Assisted in annual project and corporate SOP revisions.-Designed Study Manuals of Operations.-Performed data entry of Case Report Forms and QA auditing of data entered by others.-Developed automated database checks and produce queries.-Supervised all CRA activities as a CRA Manager.-Developed and conducted site monitoring training module of corporate orientation class.

-Performed study initiation, interim monitoring, and study close out visits.-Supervised Patient Phone Interview sub-study.-Participated in authoring an Investigator Brochure.-Assisted in Case Report Form Development.-Authored study specific SOP’s.-Maintained internal study and legal files as document controller. -Created study test data for database edit check verification.-Assisted in the design of study Manuals of Operations.-Inventoried and performed data entry of case report forms. -Assisted in QA audits of database listings, CRF’s, and source documents. -Planned Investigator and Study Coordinator Meetings.