LANA ROMANOVIĆ

 

12 Coventry Terrace, Columbus, NJ 08022 ® Residence (609) 424-0205 ® Mobile (609) 577-3590 ® rlana@comcast.net

BD21328_
 

 


Clinical Administrative Manager

  Expertise in Clinical and Regulatory Affairs in the Biotechnology and Pharmaceutical Industry

 

·         Excellent skills with Regulatory Submissions to FDA – INDs and NDAs

·         Proven abilities with Institutional Review Board Submissions

·         High level of proficiency with GCP Good Clinical Practice

·         Global Clinical Trials start-up expertise (USA, Eastern Europe, India and Asia)

·         Diplomacy with senior executives and high profile dignitaries

 

Professional Experience

 

Theradex® Systems, Inc.

Manager, Clinical Administrative Services, Princeton, NJ – 2010 to 2011 (company downsized)

International contract research organization (CRO) providing services to the pharmaceutical industry

Brought on board to oversee the administrative and site regulatory documentation of staff supporting clinical trials conducted at approximately 30 clinical sites for commercial clients to ensure quality control and regulatory compliance. Assigned projects, identified team leaders, and managed overall performance.

 

­  Driving force in a major project revamping the entire document & tracking system to a web portal SharePoint. Instrumental role in creating extensive customization to ensure data met protocols.  

­  Introduced vigilant efforts in staff training on Standard Operating Procedures (SOPs), regulatory documentation and follow through to ensure quality control in regulatory compliance.

­  Served as key liaison and internal resource to clinical and regulatory teams, particularly with adherence to ongoing major changes in FDA guidelines.  

­  Organized superior quality in records management for extensive documentation through entire clinical trial process, and for efficient retrieval for audits and general requests.

­  Coordinated with the Theradex® Safety Desk regarding IND safety reports and provided guidance to sites regarding IND safety reporting procedures.

 

Transave, Inc. 

Regulatory/Clinical Trials Associate, Monmouth Junction, NJ – 2006 to 2009

A start up Biotechnology Company

 

Provided support to members of the global study team (Managers, Directors, CMO) in the daily tasks involving initiation, planning, recruitment, execution and close out of clinical trials. Instrumental in assisting with vendor selection, contributing to selection of CRO, and management of budgets and contracts.

 

­  Established liaison relationships with ambassadors in different countries (India, E Europe and UK) and high profile physicians in top notch institutions such as Montefiore and Sloan Kettering.

­  Streamlined systems by developing a formal document nomenclature for systemic filing of regulatory/clinical files and maintained Trial Master File documents in a secure room.

­  Assisted with updating the Investigator’s Brochure and Annual Report for filing with the FDA and maintained the FDA Correspondence Log Book.

­  Collaborated extensively with Clinical Research, Operations and Manufacturing teams, CROs and vendors.

­  Trained and supported the study sites on the use of study specific equipment (spirometer), and scheduled and participated in weekly teleconferences with CROs and vendors.

 

Trilogy Leasing Company, LLC 

Contract Administrator, Cranbury, NJ – 2005 to 2006

Leasing New/Used Data Processing Equipment

Liaison in leasing transactions; handled vendor Purchase Orders and processed lease terminations. Generated sales documents, prepared correspondence regarding lease schedules, interacted with Sales Representatives, communicated with customers/vendors and performed various administrative tasks.

 

Elementis 

Project Coordinator, Hightstown, NJ – 2003 to 2005

Global Chemical Company

Managed tracking of Patent and Trademark renewals. Supported the Corporate Project Director with the creation of presentations and communications to high profile leaders and executive teams. Analyzed and updated global project budgets. Managed the purchase and inventory control of supplies to support the global project.

 

­  Acknowledged for success in obtaining the Iranian renewal for the patent for this company; collaborated with legal team, consulate in Iran and Washington.

­  Initiated and established cost saving contracts with hotels, awarding them over $250K in business due to global partners coming from UK, Scotland, Eastern Europe, as well as the Midwest.

 

Bristol-Myers Squibb

Various Administrative & Clinical Study support roles to VP of Preclinical Candidate Optimization, Senior Director of Regulatory Affairs, Dept. Head of Clinical Operations, Princeton/Plainsboro, NJ – 1990 to 2003

Instrumental role in clinical trial studies and regulatory affairs. Active involvement in attending FDA meetings with executive leader to gain approvals. Provided key support and reviewed/edited information submitted by internal departments for content and format in the FDA submission process for INDs and NDAs. Tracked departmental capital expenses and prepared quarterly $1M budgets and financial reports. Supervised/directed clerical workers and oversaw systems, records and documentation for cross-functional projects. Spearheaded the development of an Excel database for tracking vendor invoices, payments, patient enrollment, clinical supply shipments and supervisors’ expense records. Created, maintained and updated Clinical Trial Studies files and documentation for submission to the FDA and coordinated the preparation of Investigator Contracts. Selected as an executive liaison at weekly meetings with PR agencies to screen and advise on content and corporate image.

 

 

Prior Experience

Physiome , Executive Assistant to the President/CEO; Pharma Net, Inc,  Administrative Assistant to the VP - Regulatory Affairs;  State of NJ, Grants Coordinator, DEP, Administrative Assistant, Lottery Commission

 

Education • Skills • Training

 

Mercer County Community College, West Windsor, NJ - Paralegal Coursework - 60 Credits

            Certification: Notary Public of New Jersey • Languages: Serbo-Croatian: complete fluency spoken

Computer Skills: Word • Excel • PowerPoint • Outlook • EzReq • SAP • Internet Explorer • Windows® 7

 

Training & Development

 

FDA Training: Administrative, Documentation, and Protocols

Extensive training on SOPs and oncology topics, Good Clinical Practice (GCP), clinical trial research, disease states, treatment modalities, regulatory requirements, safety reporting, data management, and report writing. (Detailed Addendum available)