Job Title: Medical Monitor

Job Location:SAIC-Frederick, Inc.

Job Description:
Responsible for providing medical leadership for the oversight of investigational drug safety and associated aspects of investigational drug safety, data and safety monitoring, and related activities of the RCHSPP/B. These activities range from adverse event reporting to product safety reviews to preparation of technical and regulatory documents. Provides medical safety monitoring for ongoing clinical trials conducted under RCHSPB sponsorship. Reviews and interprets clinical data on a real-time basis in collaboration with the PI or Data Management Center, if applicable, to determine the safety of the study agents being evaluated. Reviews SAE reports from clinical sites to determine if an IND Safety Report is needed. Oversees and approves the preparation of safety information for reporting to regulatory bodies. Assures, in conjunction with Regulatory Affairs, compliance with regulatory reporting requirements for safety reporting in clinical trials, domestically and internationally. Assists with preparation of IND and IND Annual Reports as they relate to clinical safety information. Provides expertise for developing procedures to capture, manage, and report clinical trial safety data including, but not limited to, SAEs, lab abnormalities, subject withdrawals due to adverse events, capture of AE information and coding, unblinding issues, and IB updates, in accordance with regulatory requirements. Participates in protocol development, specifically protocol design and statistical analysis plans. Serves on assigned project/product teams or subteams to provide guidance regarding safety-related issues.

Job Requirements:
Must have a current MD license from a US accredited school or be license-eligible in the US. In addition to the educational requirement, five years relevant experience in drug safety within the pharmaceutical industry, academic facility or clinical research. Must have working knowledge of pharmacovigilence; clinical safety regulations and guidelines, and clinical research trials methodology, design, implementation and analysis. Must have demonstrable knowledge of FDA regulations, ICH GCP guidelines, NIH Standards of Clinical Research, and clinical trials research and management. Must have the ability to communicate effectively with the Sponsor or designee, clinical study staff and RCHSPP staff; render decisions and policy interpretations; and provide guidance and leadership in the performance of complex planning, coordination and evaluation of duties for a clinical trial project. Ability to independently identify problems and effectively offer solutions to problems. Exhibit excellent technical skills including the ability to comprehend, integrate and interpret scientific and medical data from a variety of sources.

Person of Contact:
Mary L. Siegle, SPHR. SAIC-Frederick, Inc.
Email: msiegle@ncifcrf.gov
Phone: 301-846-5366
Website: www.saic.com
http://saic.ncifcrf.gov