Dr. Robin Farmer Email & Phone Number

California, United States

Menlo Park, Ca, Us

Leading Clinical Compliance eTMF Records Management ,Quality Document Control, QMS/GCP SOP Training and management of LMS and internal GCP Education

Menlo Park, Ca, Us

Leading Clinical Systems Veeva Vault CTMS and eTMF as well as managing Records Management team

Menlo Park, Ca, Us

Responsible for the oversight of the Clinical Systems and Records Management(TMF and CTMS) Department within Clinical Compliance

Emeryville, Ca, Us

Provided management and oversight of the document control department, eTMF systems, TMF and internal training records.

Foster City, Ca, Us

Oversaw the establishment and implementation of procedures for clinical records (TMF) lifecycles in accordance with regulations and record retention policy. Managed implementation of the eTMF and maintained the security and maintenance of the Trial Master File (TMF) filerooms in all relevant Gilead TMF locations (Foster City, Seattle, and Stockley Park). Managed, development, and implement procedures for the establishment, security, and maintenance of Trial Master File and eTMF documentation for inspection. Develop and maintain Trial Master File SOPs.

Emeryville, Ca, Us

Provided leadership and management oversight of clinical document control and clinical training. Partnered with Clinical Development, Quality Assurance, and Regulatory Affairs to enable the development and maintenance of Standard Operating Procedures (SOPs) and clinical documents. Ensured Clinical Development was appropriately trained on SOPs. Managed and oversaw the team responsible for the clinical document room and maintenance and tracking of training records.

Lake Forest, Illinois, Us

Managed the Clinical Document Control Department. Oversaw the flow of documents that were submitted to the department by internal/external customers. Managed timelines, assured processes were adhered to. Kept upper management abreast of bottlenecks in work processes to ensure smooth daily workflow and completion.

Thousand Oaks, Ca, Us

Oversaw and monitored assigned company internal therapeutic products as Subject Matter Expert.Executed the coding, scanning, indexing, tracking, filing, and archiving of high volumes of clinicalrecords within the company records archive department. Performed quality assurance checks of outsidevendors of outsourced work assignments. Inspected and coordinated readiness preparations for FDAaudits for internal customers.Selected Accomplishments: Managed thirty-five direct reports individuals -- in office and remote Experienced in working in accordance with Title 21 CFR Parts 11 and 312 and ICH E6 Improved internal process workflow timelines, resulting in shorter customer response times Formulated process improvements in accordance with Standard Operating Procedures Ensured accuracy of documents filed to FDA for drug approval audits; Worked with five Contract Management Analysts within the areas of Oncology/Nephrology involvingdepartmental site contracts at high dollar levels, including coordinating with different department leaderswithin the company to obtain timely contract approvals.Selected Accomplishments: Assured excellent communication skills while interacting with other departments Achieved timely results by quickly learning the processes of the position Improved processes to ensure timely completion of all tasks assigned Increased internal customer satisfaction through rapid turnaround of signed contracts Minimized company costs by ensuring proper contracts were sent to appropriate sites

Us

Assumed sole responsibility to manage the Human Resources Department during a planned absence ofthe incumbent. Communicated orally and in writing with upper management and employees throughoutthe country in coordinating and overseeing travel arrangements to various sites, on-boarding newemployees and performing a comprehensive corporate switch in insurance providers.

Santa Barbara, Ca, Us

Gained comprehensive knowledge of human resources protocol Improved process of on-boarding new staff by eliminating redundant processes Organized process to facilitate the corporate switch from one insurance provider to another; Planned and organized student activities and events. Dealt directly with the Vice Chancellor andChancellor offices to advocate funding for University cultural functions. Conducted and mediatedconflict resolution sessions to promote cooperation among students.Selected Accomplishments: Addressed students in public speaking formats at University functions Advised students and parents regarding University cultural events Clarified and differentiated the various educational program options to students

Washington, District Of Columbia, Us

Worked in the office of Presidential Personnel preparing various documents for the Presidential Library.Responsible for answering letters addressed to the President of the United States and routing responses tothe appropriate Government departmental offices for review and signatures.Selected Accomplishments: Guaranteed a high level of professionalism and decorum while handling confidential and time sensitive information Maximized work time effectiveness to ensure all tasks were completed during assigned hours Maintained relationships with other internal offices to aid in timely transfer of information as needed

Filed legal documents with the Ventura County Court. Basic office duties pertaining to legal matters.

Doctor Of Education - Edd, Oranizational Leadership

Mba, Organizational Leadership And Management

Negoitation And Mediation Certificiate

Ba, Law And Society