Danielle McNulty

• Consulting responsibilities include full scope of study activities, including site activation, patient recruitment, study monitoring, and site and vendor management on Phase 3 trial.

• Assist with the development of Phase I-IV Dermatology protocols as they relate to the operational aspects of the trial
• Lead the creation of consent forms, monitoring plans, case report forms, source documents, and other clinical documents related to clinical trials
• Review medical monitoring plans
• Lead the selection and management of CROs, vendors, and other consultants to ensure adherence to domestic and international regulations and standards (GCP, MDD, ICH)
• Assist with the negotiation of contracts and budgets with clinical investigators and other vendors
• Participate in the development and maintenance of clinical project timelines
• Work closely with CMC and Research departments to ensure adequate clinical and non-clinical supplies, open communications for clinical trial inputs and outputs, and co-authoring of related clinical trial procedural documents
• Ensure investigative site compliance with protocols and overall clinical objectives; including traveling to sites to conduct pre-study, initiation, interim and closeout visits, site and study management, trial management file maintenance, and/or co-monitor with CRO or contract associates
• Organize and manage SIV's
• Supervise clinical site monitors (internal and/or contract), including review and approval of interim monitoring visits and other study documents
• Oversee domestic and international shipping of investigational products and collection samples with transit temperature requirements
• Oversee domestic and international shipping of clinical trial supplies and equipment
• Lead or participate in preparation of IRB or International Ethics Committee submissions as required
• Partner with the Data Manager for EDC design, implementation, data review and cleaning, database lock, and CSR data as the subject matter expert
• Assist the Medical Monitor in safety review and reporting
• Work prospectively with Clinical Operations study team(s), vendors, and investigative sites to attain a state of audit- readiness, and prepare for and support audits or inspections of sites and sponsor as required
• Lead internal study team meetings
• Work with project management to keep the project plan current and managed to critical path
• Work closely with the Chief Medical Officer and Director of Clinical Operations to lead the planning and execution of successful Investigator meetings
• Lead or participate in preparation of IRB or International Ethics Committee submissions as required
• Participate in preparation of FDA submissions as required
• Mentor Clinical Trial Associates (CTAs) and Interns
• Perform other related duties as required to support the Clinical Operations Team and company goals.

• Serve as primary contact for Dermatology Sponsors on operational and study deliverable issues
• Maintain in depth knowledge or protocols
• Develop operational project plans
• Oversee the day-to-day operations of the projects
• Manage and mentor project management team
• Provide projections, forecasts, and project updates to executive team
• Track and manage clinical trial budgets
• Coordinate with business development on RFPs
• Review Sponsor and Vendor master service agreements and work orders
• Continuously evaluates process improvements, implements new or updated procedures to create efficiencies and best practices for managing the clinical trials
• Lead BID defenses

• Facilitate periodic (e.g., weekly) MLR meetings, to conduct reviews, set and reinforce expectations of process and planning or confirming that materials are submitted on time/in line with FDA regulations, including as it pertains to their approval and OPDP submission prior to use, as applicable.
• Creating the MLR schedule and agendas
• Verifying that submitted materials meet the pre-defined quality standards for MLR review, and that the information uploaded in ePROMO EDMS is complete (e.g. availability of references or other information sources)
• Distributing to committee members materials for review with deadlines;
• Tracking the review process and MLR decisions;
• Documenting and maintaining consolidated comments (“blacklines”) during MLR meetings;
• Coordinating and documenting approvals;
• Coordinating resubmissions and elevation of MLR submissions for supplemental review;
• Ensuring, along with the Initiator of the piece, that all agreed-upon changes are reflected in the final version of the submission; and confirming materials have final approval of Regulatory Affairs, Legal, and Medical and are cleared for release.
• Oversee the execution of promotional reviews in general, as well as operational compliance of the MLR by working closely with Medical, Legal/Compliance, and Regulatory Affairs towards the completion of the review, approval, documentation & submission of promotional materials.
• Maintain the system and repositories used to conduct compliance reviews of promotional materials in an audit ready state at all times.
• Collaborate with Regulatory Affairs to ensure proper submission of materials to OPDP via the FDA Form 2253 process, as required.
• Onboard new users: train on ePROMO EDMS, ensure timely communications with stakeholders on update and process improvements as well as content management system enhancements.

• Manage the day-to-day activities for successful start-up and completion of Phase III global clinical programs
• Develop and monitor study budgets and timelines
• Selection and oversight of CRO, vendors and contract personnel
• Partner with function peers to manage, adjust and revise project timelines and budgets, as required
• Participate in development of SOPs, protocols, Investigator Brochures, INDs, CSRs and other clinical and safety documents
• Contribute to development of abstracts, presentations, manuscripts and other external forms of communication
• Determine activities that are critical to company success and priorities within the functional area
• Anticipates obstacles of varying complexity and implements solutions to achieve project goals

• Provided clinical management for outside vendors from start-up through study closure
• Line management of CRAs
• Drafted study-related documents such as the informed consent template, source documents and protocol-specific training documents
• Safety Management oversight
• Oversight of the trial master file to ensure that it is complete and up to date
• Managed the oversight of vendor budgets
• Primary liaison between vendors and manages the Project Team to ensure study progress is accordance to upper management requirements
• Maintained effective communication with vendors and/or sites as required through frequent meetings, teleconferences, written correspondence
• Responsible for quality, composition and maintenance of the study files
• Maintained and evaluates study progress by using tracking systems, status reports, site visit scheduling, and project budget review; ensures expected progress and performance are on target throughout the study
• Developed project specific procedures as necessary, with responsible functional areas
• Tracked and adhered to project budget and milestones
• Co-ordinates and generates contracts with external providers/third party vendors, and investigators
• Reviewed and approved clinical project expenses and ensures all study related contractual and budgeting issues are upheld and performed; over sees and tracks invoicing and payment issues, as required
• Chairs project team meeting/teleconferences Site selection, training of investigators
• Worked with Lead CRA/Clinical Manager to maintain regular communication with CRAs to review overall study progress
• Oversaw the regulatory document collection and submission process; maintained liaison with QA personnel to ensure a trial is appropriately audited

• Primary liaison between Premier Research and the client on studies; manages the Project Team to ensure study progress is according to client and Premier Research requirements
• Worked on multiple projects simultaneously
• Maintained effective communication with client and/or director within Premier Research as required through frequent meetings, teleconferences, written correspondence, and study progress reports
• Provided supervision of clinical team including, but not limited to, performance management (quality, quantity and timelines of work performed), guidance on corporate policy, training and support
• Responsible for quality, composition and maintenance of the study files for all assigned studies
• Ensured completion of all tasks assigned to members for the project team, including Regulatory, Data Management
• Biostatistics, QC/QA, Clinical Monitoring, and Medical Affairs/Safety
• Maintained working knowledge of assigned Protocols, Case Report Forms, and any other study-related documents; develops a Project Operations Manual and monitors against project progress; ensures project activity compliance with plan; takes corrective action where necessary; provides knowledgeable, demonstrated leadership of all study requirements to Premier Research staff
• Maintained and evaluates study progress by using company tracking systems, status reports, site visit scheduling, and project budget review; ensures expected progress and performance are on target throughout the study both at the project team and investigator level
• Developed project specific procedures as necessary, with responsible functional areas
• Tracked and adhered to project budget and milestones to ensure project profitability; takes corrective measures where necessary to keep project in line with budget and profit expectations; identifies scope of work changes on assigned projects
• Co-ordinates and generates contracts with external providers/third party vendors, and investigators, if applicable
• Reviewed and approved clinical project expenses and ensures all study related contractual and budgeting issues are upheld and performed; over sees and tracks invoicing and payment issues, as required
• Worked with Lead CRA/Clinical Manager to maintain regular communication with CRAs to review overall study progress and to resolve any therapeutic or recruitment issues
• Oversaw the regulatory document collection and submission process; maintained liaison with QA personnel to ensure a trial is appropriately audited
• Reviewed site visit reports as per SOP requirements in order to stay current with site issues and CRA performance on studies
• Coordinated the data cleanup between Clinical Operations, Data Management, Biostatistics, and Medical Affairs/Safety
• Assisted in Business Development activities and presented at bid defense meetings
• Assisted in prospective study feasibility assessment

• Assisted sponsor with protocol development, case report form design, informed consent form content, investigator agreement and monitoring plan development
• Prepared Project Plan including timelines and deliverables
• Developed appropriate study tools and tracking systems
• Supervised activities of the monitors, including scheduling of monitoring visits, other activities associated with the project (e.g., review of visit reports for completeness and accuracy, assisting monitors with "problem sites", etc.), and time accountability for the project
• Coordinated the planning and conduct of the investigator and training meetings
• Coordinated Investigator Product and other services provided by vendors (e.g., IVRS, lab services) as needed
• Ensured processing and reporting of SAEs
• Ensured effective communication between sponsor and all project team members
• Provided sponsor and Clinsys senior management with status reports and metrics throughout the project
• Reviewed and approved monitors' expenses and time associated with the project
• Conducted quality control and co-monitoring visits with monitors to ensure quality and compliance with SOPs, GCPs and project requirements
• Served as back-up monitor as needed
• Provided training, coaching and mentoring for assistant project managers, monitors and clinical trial coordinators
• Assisted with the preparation and presentation of capability presentations to existing or new clients

• Managed Phase I-IV Dermatology clinical trials form start to finish for multi-site US and international studies
• Provided oversight in site selection process and mass mailing process for study documents
• Prepared and negotiated all site budgets and contracts
• Collected, reviewed and submitted all regulatory documents to IRB
• Collaborated with meeting coordinators on all aspects of Investigator Meetings
• Prepared, selected and coordinated Laboratory for specimen samples for International and US shipment of study drug, lab kits, and other study materials for US and International sites
• Responsible for managing and overseeing job responsibilities of vendors, CRAs, data management, and other members of study team
• Served as Lead CRA on various studies, monitoring 1 to 2 sites, as well as reviewed and approved monitoring reports
• Accountable for administrative report and updates sent to the sponsor
• Key contact person and decision maker for all vendors, study team, sponsor, and sites
• Participated in new staff training

• Responsible for the start-up and continued growth of the dermatology clinical trials division
• Played a leadership role in the business development of new business for conducting dermatology clinical trials
• Created presentations for new clients and proposals for potential projects
• Served as sponsor liaison during proposal phase to successful negotiation of the contract
• Developed and maintained relationships with outside sub-contractors, including Investigators
• Managed activities of clinical coordinators and provided leadership and management to ensure activities matched project timelines
• Conducted new staff training
• Calculated the department budgets and prepared projections
• Provided oversight for all dermatology projects and coordinated all aspects of study related duties

• Coordinated and trained CRAs for study-specific needs
• Managed Investigator sites
• Identified, qualified, and Initiated sites
• Performed field monitoring of Investigator sites
• Maintained Central Files Managed clinical trial coordinators
• Created and negotiated clinical trial budgets and contracts
• Created Informed Consents and amendments
• Coordinated Investigator payments
• Performed clinical review of subject files for Data Management
• Facilitated team meetings
• Performed trouble-shooting of problems for efficient and effective solutions

• Facilitated communication between team members regarding project tasks and deadlines.
• Produced and distributed study newsletters and other forms of communication.
• Sent enrollment reminders to investigators
• Collected and tracked enrollment information for each site
• Conducted payment administration and tracked according to the site contract (monthly milestones)
• Facilitated and negotiated site budget and site contract preparation of status reports and updates for the project manager

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• Handled screening of potential subjects
• Compiled all regulatory, protocol, and subject consent forms
• Developed proper documentation of study progress
• Completion of CRFs