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• Manages the eTMF for assigned programs/projects; identifies, requests and ensures delivery of outstanding and outdated documents from CROs/vendors/investigators/consultants • Periodically during study conduct and in accordance with the study eTMF oversight plan, reviews overall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• Provides oversight and mentorship of Clinical Trial Assistant(s), Clinical Trial Coordinator(s) and directs and oversees external consultant(s) for eTMF related activities• May assist with document retrieval, minuting and other related tasks as needed in inspections/audits and will be part of inspection readiness planning• Assists QA and Clinical Operations leadership in reviewing SOPs related to eTMF and inspection readiness / document control• Provides back-up support to Regulatory Operations

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. • Schedule and lead site start-up meetings with clinical team to review any issues, items for escalation, regulatory document issues, and IRB status. • Support Clinical Trial Management System (CTMS) data entry and regulatory document management lifecycle of Trial Master File (TMF) study documents with strict adherence to ICH, GCP and FDA regulations as applicable. • Direct the performance of periodic regulatory document QC and reconciliation activities to ensure document quality standards are maintained for eTMF documents. • Provide operational expertise and manage the quality and compliance of CTMS and TMF.• Responsible for the training and mentoring of junior team members. • Develop and maintains SOPs, processes, templates and training documents. • Enhance organizational performance and efficiency through the collaboration with other departments on process improvement initiatives across all Clinical Regulatory and Study Start-up activities.

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. • Maintained proactive communication with all sites to ensure quality standards and timelines are met.• Work collaboratively with data management on data reviews, query resolution, and cohort data locks.• Partner with Contracts and Outsourcing to prepare site and vendor contracts.• Actively participate as member of CTMS implementation team. Clinical Trial Assistant, Clinical Trial Management• Support set-up and maintenance of the Study Master File (SMF).• Assist in the collection of essential documents, and review them for completeness and compliance with the study protocol, LICR SOPs and applicable regulations.• Establish and maintain the tracking tools for assigned trials, including collaborative trials.• Produce reports from tracking systems as required.• Distribute clinical trial related materials to study sites or clinical team members.• Act as a central contact for designated project communications, correspondence and associated documentation.• Assist in preparation of meeting agendas and minutes, and track the resulting action items.• Assist CRAs in preparation for clinical trial site monitoring visits.• Assist in the creation of study materials, including essential documents, presentations, and reports.• Establish and maintain public trial registries (e.g. www.clinicaltrials.gov).• Perform other administrative tasks to support team members as directed.

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 as per Forest policy.• 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.• Assist senior team members with in the planning, preparation, and on-site support of investigators meetings.• Assist with ongoing data review and discuss comments with the clinical study team as needed.• Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings.• Support the Regional Site Managers by providing study related information and supplies, as requested.• Communicate with IRBs and outside vendors to provide information and/or resolution to specific requests/issues.• Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies).• Contribute to process improvement efforts including task forces and committees.• Support clinical team with requests from management and function as a back up to general Clinical Scientist activities as needed.• Deliver training related to day-to-day responsibilities for new CTA and CS hires within department.

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 & beverage and travel schedules. • 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.• Audit program budget by tracking and reviewing all meeting planning and vendor invoices against budgeted items and contract requirements. • Plan and conduct formal and informal participation surveys.

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.• Advise customers on best practices and vendor management.• Assist with the development of working documents/SOPs for contract/vendor management.

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.• Maintain files, tracking logs & master attendance as directed.• Handle the collection and distribution of tax forms from outside vendors.• Prepare, reconcile and submit expense reports.• Handle phone calls and inquiries from outside vendors.

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• Coordinate travel arrangements and itinaries.• Continuously prepare departmental expense reports in excess of $20,000 per month.• Securely handle cash advances and foreign currency exchanges on a weekly basis.

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