Danielle Mccabe Email & Phone Number

New York, US

New York, US

• Manages the eTMF for assigned programs/projects; identifies, requests and ensures delivery of outstanding and outdated documents from CROs/vendors/investigators/consultants
• Periodically during study conduct and in accordance with the study eTMF oversight plan, reviews overall study eTMF for organization, quality, and for completeness as per ICH GCP requirements
• Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP and regulatory requirements and consistent with the protocol for assigned studies/programs
• Works with Regulatory Affairs and Regulatory Operations, identifies and prepares documents for country requirements in the framework of regulatory submissions as needed
• Provides leadership in vendor management and issue escalation
• Assists Clinical Operations leaders as appropriate and as needed in various study management and monitoring activities, including liaising with monitors, CROs and vendors for study related tasks

New York, NY, US

• Direct and manage the delivery of all required start-up, maintenance and regulatory activities for assigned sites and/or studies.
• Manage the overall quality, completeness and timely release of the Site Start-Up Regulatory Package required for site initiation and release of investigational product.
• Responsible for engaging clinical site personnel in the negotiation of investigator site contracts and budgets and ethics and regulatory submissions.
• Creation of master informed consents (ICFs), review of local ICFs, review and tracking and ongoing maintenance and review of essential documents.
• Work with Central and Local IRBs to acquire approval for Final Protocol, Amendments, ICFs, and any additional study documents.
• Assist study teams in site feasibility and/or site identification for assigned studies.

New York, NY, US

• Associate Clinical Project Manager, Clinical Trial Management
• Lead study management activities for assigned trials and track study progress against agreed upon timelines and goals.
• Conduct qualification and site initiation visits to train sites on protocol requirements.
• Anticipate issues that may affect study goals or timelines put measures in place to correct or mitigate them.
• Meet with upper management on study status updates and resource allocation.
• Provide input on protocol design and prepare necessary informed consent documents.

US

• Support study feasibility activities and perform database/web searches for sites as needed.
• Work closely with the Site Start Up (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation.
• Organize and maintain project working files and track critical documents. Report discrepancies to the appropriate clinical team member in a timely manner and reconcile and transmit all essential documentation to CDIC.
• Track and assist with processing site/vendor payments. Follow up on any issues as required.
• Collect and track patient enrollment information and update study management reports as necessary.
• Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems.

US

• Investigate meeting locations and negotiate hotel contracts/prices to achieve the maximum savings for the company without compromising meeting quality.
• Plan and implement meetings, conferences and special functions, which include recommending site locations that fall within defined constraints of the budget and compliance guidelines.
• Manage meeting staff and cross-departmental project teams of internal customers and external vendors to define project scopes, business requirements, set deliverables, and keep projects on schedule and within budget.
• Oversee all logistical aspects of various company meetings including Request For Proposals, planning, budgeting, communication, surveys, reservations, contract negotiations, rooming lists, audio visual needs, food &.
• Manage the registration process for attendees in the program registration system.
• Prepare program materials, including but not limited to, invitations, confirmations, welcome packets, name badges and tent cards for each assigned meeting.

US

• Draft, negotiate, and manage contracts for assigned projects.
• Work with outside vendors to obtain quotes on projects, prepare bid packages for vendor selection for goods and services.
• Ensure all contractual and financial requirements have been met.
• Provide consistency across assigned projects by identifying process-related issues and assuring implementation of process improvements.
• Provide customers with status reports of assigned projects.
• Assist with the development of processes and standards templates.

US

• Assist the Director of Clinical Trial Support, in addition to the Contracts Management Group, Payments Group, Clinical Document Information Center, and the Meeting Planning Group.
• Manage Outlook calendar for the Director Clinical Trial Support and Associate Director of the Contracts Management Group.
• Arrange internal and external meetings and conferences.
• Coordinate travel arrangements and itinaries.
• Maintain current Investigator Lists.
• Maintain all Confidential Disclosure Agreements.

New York, New York, US

• Manage daily administrative activities of one Senior Vice President, Head of Logistics and two Vice Presidents, Head of Document Management and Head of Training & Conference Services.
• Responsible for all lease terminations and invoicing for all Logistic and Document Management vendors.
• Maintain high call volume from internal and external contacts and vendors.
• Compose and maintain PowerPoint presentations, Access databases, and Excel spreadsheets per department protocol.
• Coordinate and maintain Outlook calendars for one Senior Vice President and two Vice Presidents.
• Plan and coordinate internal and external meetings

New York, New York, US

• Respond to heavy influx of telephone calls from clients, prospective clients and other financial institutions in a timely and efficient manner.
• Maintain / update various records in computer system, including those related to personnel.
• Schedule meetings and book conference rooms for senior management staff.
• Work on special projects and assignments, as needed; examples including assisting with various marketing and promotional activities.
• Provide training, direction and support to newly-hired personnel