Company DescriptionMEDVACON Life Sciences works with many leading pharmaceutical companies to hire consultants, contractor's and full-time employees to join their organizations. One of our pharmaceutical clients is looking to fill a Development Business Operations Associate position ON-SITE in Foster City, CA. This is a HYBRID position, worked two days per week in office, and the rest is worked remotely.Job DescriptionLocation: HYBRID – 2 days per week on-site in Foster City, CAContract Duration: 6 monthsResponsibilities:Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreementsCollaborate with Development Business Operations leadership, Development Business Operations functional groups, clinical operations teams, and functional areas outside of Development Business Operations to ensure compliance with policies, procedures, and the records management/TMF archival initiativeWork with management and DMT personnel in the development, implementation and maintenance of classification and filing systems to meet administrative, research, regulatory, legal, and financial requirements (e.g. filing of agreements in legal archive, Apttus, and eTMF GDAR system)Data mining/modeling (e.g. statistical models) and enhancing data collection procedures to identify patterns and extract knowledge from large data setsProcessing, cleansing, and verifying the integrity of data used for analysisDoing ad-hoc analysis of department data and presenting results in a clear mannerWork with management to manage business continuity procedures, including management of paper agreementsPerform central intake activities including creating records of incoming documents within the first business day of receipt, filing of incoming documents, and retrieve copies of paper protocol agreements from TMF room for Apttus filingCollaborate with management to generate central intake report on a daily and published in a timely fashionResponsible for keeping DMT Master Inventory up to date and accurateEvaluate regulatory and business recordkeeping, archiving requirements, and organizational objectives and ensure Development Business Operations DMT is aligned with allResponsible for the continued maintenance of eTMF (GDAR) and Apttus contract filingFile incoming documents and retrieve copy of paper protocol agreements from TMF room for Apttus filingEnsure record filing is kept up to date is performed accurately by DMT membersWork with management to develop and maintain quality assurance and control plansResponsible for monitoring accuracy of the team’s work by providing reports and metrics to management teamQualificationsQualifications / Requirements:3-5 plus years of relevant experienceBA/BS required3plus years of data science experience with common data science toolkits and data visualization tools5 plus years of project management experience with PMP preferred3 plus years of Clinical Research Associate (CRA) or relevant records management/ TMF management experience equivalent experience preferredKnowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document ManagementAdditional InformationW2/1099 CONTRACT CANDIDATES ONLY!!! NO C2C/CONSULTANTS!!!