Frank Clancy Email & Phone Number

San Diego, California, US

Madison, Wisconsin, US

• Assist with studies and support the logistical aspects of clinical trial conduct in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs)
• Maintain Trial Master File by setting up and using tracking tools
• Assist in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to SOPs and study requirements, as well as periodic review of study files for accuracy and.
• Assist with review of clinical study data and essential documents for quality control purposes.
• Work closely with other members of the Clinical Team to support activities during a study startup, study execution and close out phases
• Facilitate and document the internal project meetings, draft internal and external correspondence and file the associated documentation; schedule team / internal meetings and track attendance

Seattle, WA, US

• Streamlined operations across studies by identifying gaps and consistencies. Edited effected policy & procedures and SOPs in accordance with ICH/GCP and applicable regulations.
• Proactively identified study and clinical department tracking needs: designed trackers, assembled, audited and recorded records for accuracy.
• eTrial Master File review and reconciliation (Veeva Vault)
• Created and maintained a master list of potential sites globally across studies.
• Managed outsourced global payment providers (DrugDev, using Bioclinica software) for in-house and CRO-managed studies. Reconciled discrepancies between invoicing and electronic data entries (Medidata/Rave).
• Assisted with the development and continued editing of site tools

• Trained newly hired Clinical Trial Assistants to perform daily tasks.
• Organized operational aspects of multiple Phase III & IV clinical studies throughout study life-cycle, maintaining multiple tracking spreadsheets
• Coordinated pre-study site selection matrix by increasing potential list to 4000+ sites through research, vetting purchased lists and revising Site Contact Questionnaires; Tracked pre-study site selection.
• Initiated and tracked site contract negotiations; Managed start up deliverables of study materials, clinical, marketing and vendor supplies; Served as point of contact for all study sites and monitors for additional.
• Organized, maintained multiple studies’ TMFs, transitioning from hard to electronic filing systems during study-end quality review.
• Received, reviewed and tracked (updates to) sites’ essential regulatory, financial and critical documents, as well as licenses, ensuring accuracy and compliance to company SOPs and federal & international guidelines.

Jersey City, NJ, US

• Trained and mentored department administrative staff.
• Managed department and executive meeting logistics (WebEx, NetMeeting, videoconferencing, teleconferencing, etc.), prepared meeting agendas, materials, and minutes; Managed organization charts and contact lists.
• Managed executive calendars, academic and professional memberships, expenses reporting, professional meeting registrations and travel for executive and supporting staff.
• Organized international and domestic meeting logistics and operations for staff, partners and consultants.
• Executed confidentiality agreements and contracts - negotiating hourly and per diem fees - for study and executive consultants.
• Coordinated with Human Resources and employment vendors to systematize resume review and interview schedules during three-month expansion of over 300 candidates and subsequent 80+ hires.

Acted as the central key to office organization - tracked priorities; managed Managements' schedules with a responsiveness to their needs/priorities; Oversaw department forecast and budget; created media/trade/publication contact data reference source; tracked & coordinated all media coverage, maintaining accurate information for website communication.

Versatile management and administrative responsibilities included: Created, designed and managed direct mail campaign strategies and promotions; Developed strategic alliance/partnership negotiations and constructing public relations initiatives; Streamline operations; Meeting planning and event management.Clients included: WNET/Thirteen, Gevity Human.

Supported the planning and coordination of marketing, business development and sales strategy implementations: Direct marketing, CRM, Trade Shows, Sponsorships, Advertising and Promotions, Outsource Telemarketing and Educational seminars; Duties included promotional material development and packaging, market research, competitive analysis.

New York, New York, US

Re-structured, trained and supervised Accounts Payable, Administrative and Facility personnel for full service, multi-cultural advertising and marketing agency and partner companies. Managed purchasing, inventory and property controls, cost allocation, vendor payments, office/records management, shipping/receiving, travel/transport, as well as Health.

Provided Sales support for International Sales Managers, subsidiaries and distributors. Processed and coordinated inventory, purchase order and service requests, as well as repair & replacement of defective units and parts. Coordinated shipping with production and material needs with Procurement. Reconstructed international distributor and customer.