• Oversee operational aspects of the Trial Master File (TMF) from study start-up through study close-out archiving, providing guidance to functional area team members and their vendors.• Define and manage projects and work being performed by external CRIM service providers to ensure timelines are met and deliverables meet expectations.• Define and manage projects to ensure completeness and integrity of legacy TMFs for drug programs/studies (e.g., records from acquisitions/in-licensing deals, office relocations, etc.).• Manage and/or contribute to projects related to development and implementation of new or enhanced processes and/or technologies related to the management of the clinical portion of the TMF.

• Responsible for ensuring appropriate resource is available and projected to support all clinical document management trials (Phase I-IV) for Clinical Development Operations & Biometrics (CDO&B) Department.• Ensure quality and compliant document management deliverables are met in a timely manner during the lifecycle of a study. • Oversee US CDO&B Archivist management of record archival and record retention processes.• Represent Global Clinical Document Management in strategy development for optimizing departmental processes as well as outsourced business model. • Collaborate with fellow Clinical Document Managers and/or Clinical Document Management Associate Directors to ensure global processes are being implemented; co-ordinate effective communication between global Clinical Document Management team and Clinical Document Management Director.• Lead efforts across functions in the proposal, development and/or implementation of, tools and practices to instill inspection readiness within the department.• Oversee initiatives in the process development for electronic Trial Master File including assessment of service providers for scanning services, and strategy for compliance with ICH/GCP regulations and guidances and company SOP policies and processes.• Interface with global functions such as Records Management, Compliance, Regulatory and Legal to develop, implement or adjust processes where necessary to ensure compliance of company practices and procedures.• Line management of permanent and contract US and UK Clinical Document Management staff; coach direct reports at varying levels in development; ensure staff has established business and development goals and ongoing performance management assessments and feedback.

• Collection, review, approval, tracking, and filing clinical trial documentation in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies according to established timelines. Coordinating and/or tracking central/local IRB or EC site submissions. Working closely with CRO, if applicable, to ensure submission deadlines are met and appropriate approvals obtained.• Review of informed consent forms, ensuring, if appropriate, that any procedural or medical or safety change within a site specific informed consent form are acceptable to the trial’s Therapeutic Area Representative. Also ensuring that any legal modifications within a site-specific informed consent form are acceptable to Centocor’s Legal Department.• Development and training of applicable Centocor personnel on SOPs, worksheets, workflow, and guidelines related to the conduct of Trial Document Services for trials who have site management using internal/contracted CRA resources and those outsourced to CROs.

• Supported clinical trial mangers in all site communications (internally and globally). Served as liaison for field monitors and consultants, coordinating communications among internal study team and field operations. Coordinated and distributed study documents and Discovery Labs communications to sites. Maintained call logs and other documentation of correspondence with sites. Prepared and/or distributed study newsletters, IND safety letters, press releases, and related communications.• Coordinated in-house site start-up activities. Served as primary site contact person throughout study start-up. Responsible for the collection, review, tracking, translation, and transmitting of regulatory documents throughout lifecycle of the study. Maintained close relationships with key site personnel to ensure that all necessary documents were collected prior to shipment of investigational drug and study site initiation. Maintained study central and investigator files; prepared records for FDA Inspection in 2005.• Updated study progress reports (i.e., enrollment, budget, timeline) and activity spreadsheets. Coordinated key operations for two Phase III multinational clinical trials: planned investigator meetings, shipment of drug and non-drug supplies, processing of grant payments, scheduling of initiation visits, etc.

• As recruiter assistant made initial contact calls and pre-qualified candidates for current job openings. Promoted to technical recruiter, became responsible for identifying, qualifying, interviewing, referencing, and placing candidates in contract and permanent IT employment opportunities throughout the country.

• Provided primary administrative support and first point of contact for a large technical staffing firm. In May 2000 was promoted to Marketing Specialist, duties included Internet advertising, maintaining online candidate and career database, and managing the National Networking Referral program.