Bobby Clark Email & Phone Number

San Antonio, TX, US

Deerfield, Illinois, US

• Works as a member of Clinical Operations to lead technical integration execution and risk-based monitoring business specification development for clinical trials. Interacts cross functionally within sponsor.
• Manage visual analytic business specification activities with input from cross functional study teams to determine study level dashboards to be utilized for monitoring/oversight during the study.
• Lead development & implementation of ePlatform components to ensure efficient performance of the integrated platform.
• Lead communication pathways for new and established integration data streams in collaboration with internal and external stakeholders.
• Liaison with internal and external project teams to manage the integration of new ePlatform components and associated training.
• Manage weekly integration meetings to review integrated vendor timelines and processes to ensure seamless execution of technology.

Morrisville, NC, US

• Risk Manager accountable for the oversight, execution, and management of Risk Based Monitoring (RBM) processes and day-to-day activities for one or more programs and/or assigned trials in conformance to all relevant.
• Served as the RBM liaison with internal and external project teams and functional areas for assigned programs/studies.
• Oversaw risk management activities to ensure consistency in execution across programs and studies.
• Led the development, implementation and continuous improvement of the RBM activities for assigned studies.
• The Risk Manager represented the Risk Management Group on program team meetings.
• Oversaw training of internal project team members and data stewards on RBM.

Morrisville, NC, US

• Maintained timely and effective communication among team members and site staff.
• Developed clinical plans and guidelines, including clinical monitoring plans.
• Reviewed the study scope of work, budget, and protocol content. Provided training to project teams on protocol, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and.
• Prepared and presented materials for bid defense meetings.
• Provided status reports to senior management and the Sponsor on-site initiation, enrollment, visit(s) scheduled, and trip report completion.
• Was responsible for the supervision and administrative oversight of direct reports. Completed performance. Ensured CRA metrics were met. Mentored and evaluated workload and metric compliance of CRAs. Identified project.

Princeton, New Jersey, US

• Lead core project team and facilitate team's ability to lead extended/complete project team.
• Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services.
• Serve as escalation point for Clinical Research Associate issues.
• Resolve conflicts as needed.
• Monitor project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations.
• Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Covance and client requirements.

Paris, France, FR

• Assumed North American primary oversight and responsibility for the conduct of a global Phase III Multiple Sclerosis clinical study from initiation through close out.
• Oversaw North American CRO – 25 CRAs (81 clinical sites in US & Canada; 506 Subjects).
• Planed the regional clinical trial timelines, budgets, and resources needed to achieve program objectives and corporate milestones.
• Reviewed and approved monitoring visit reports, expense reports, and study payments.
• Oversaw the construct, review and editing of protocols/amendments, investigator’s brochures, Study Operations Manual, Monitor’s Manual, source document templates and Electronic Case Report Forms (eCRFs).
• Prepared complex components of amendments, periodic study reports, and final study reports.

Paris, France, FR

• Assumed supportive oversight and responsibility for the conduct of a global Phase II Multiple Sclerosis clinical study from initiation through close out.
• Oversaw global in-house CRAs and CROs – 15 CRAs (49 clinical sites in US, UK, Croatia, Russia & Poland; 334 Subjects).
• Supported activities such as planning the clinical trial timelines, budgets, and resources needed to achieve program objectives and corporate milestones.
• Reviewed and approved monitoring visit reports, expense reports, and study payments.
• Supported activities such as the construct, review and editing of protocols/amendments, investigator’s brochures, Study Operations Manual, Monitor’s Manual, source document templates and Case Report Forms (CRFs).
• Prepared and participated in the presentations of in-house and outside symposia / medical meetings.

• Supported activities involved in the conduct of a global Phase II Multiple Sclerosis clinical study, specifically on-site study monitoring from initiation through close out.
• Assisted in the oversight of US in-house CRAs and CROs – 6 CRAs (31 clinical sites in US; 156 Subjects).
• Monitored clinical sites, audited CRAs, prepared monitoring reports and completed DCF process.
• Assisted in the maintenance of in-house GCP documentation and the development of: tracking databases, study manuals, investigational site communication, and informed consent templates.
• Reviewed and edited protocols, and participated in the design of Case Report Forms (CRFs).
• Actively participated in the initiation and close out of study sites.

• Provided clinical pharmacy services to clinical research teams in order to achieve clinical study objectives.
• Developed drug forecasts and drug demand tables based on clinical protocol design, patient enrollment, drug inventories and manufacturing schedules.
• Directed planning and operations for packaging, labeling and distribution of clinical trial material.
• Educated internal and external clinical study staff on pharmacy issues through in-services, clinical site visits and/or investigator meetings.
• Prepared, reviewed, and revised clinical study drug information for inclusion into clinical study protocols.
• Developed strategies to optimize the conduct of clinical trials to meet the overall program objectives.

• Directed several aspects of pharmaceutical drug product development and manufacturing including project management of in-house and contract projects.
• Organized and lead project teams, convened team meetings, prepared meeting agendas, composed and issued meeting results, follow-up on action items, and identified project issues and actively participated in resolution.
• Conducted critical path analyses and evaluated tactical options and alternative integrated plans.
• Developed and implemented work plans/budgets associated with fill, packaging, labeling, release testing, and controls used in the preparation of investigational clinical trial materials.
• Was responsible for evaluation, selection, and management of contract pharmaceutical manufacturing services in support of production of clinical trial materials.
• Other duties included site audits of contract manufacturing organizations, review of drug product production batch records and ensure that production operations are compliant with all applicable Federal, State and.

• Developed and maintained a document management system for the Regulatory Affairs department.
• Maintained IND files and databases for all active INDs.
• Prepared and reviewed regulatory submissions to the FDA.
• Reviewed clinical protocols, compassionate treatment requests, and adverse events reports.
• Designed and prepared SOPs pertaining to Regulatory Affairs functions.
• Maintained working knowledge and understanding of CFR21, parts 50, 56, 210, 211, 312, and 314.

• Was responsible for the implementation of the laboratory quality assurance program.
• Supervised laboratory QC documentation, as well as, reviewed and approved analytical and statistical data for QC reports.
• Performed statistical analysis utilizing the results of quality control analysis generated by the laboratory in order to create control charts and resolve non-conformances and out of control situations.
• Prepared project QC reports including electronic deliverables for environmental clientele.
• Other responsibilities have included laboratory analysis of environmental samples, sample control, hazardous waste management, and prepared and collected samples from environmental sites.