Clinical Contracts Associate - II

Description:

The Development Business Operations Associate II in the Document Management Team (DMT) will collaborate with Development Business Operations functional groups, Clinical Records, Clinical Operations Teams, and Development Business Operations functional groups in the planning, development, and implementation of standards, processes, and projects for DMT designed to ensure the effective and efficient archiving of clinical agreements and related information. Comply with relevant regulatory, legal, country-specific, and corporate requirements to produce and maintain inspection readiness for clinical records.

Job Responsibilities:
• Maintain thorough and current knowledge and understanding of GCP, ICH, and GLP regulations associated with the maintenance and retention of clinical agreements
• Collaborate 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 practices of company records management/TMF archival initiative
• Work 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
• Data mining/modeling (e.g. statistical models) and enhancing data collection procedures to identify patterns and extract knowledge from large data sets
• Processing, cleansing, and verifying the integrity of data used for analysis
• Doing an ad-hoc analysis of department data and presenting results in a clear manner
• Work with management to manage business continuity procedures, including management of paper agreements
• Perform central intake activities including creating records of incoming documents within the first business day of receipt, filing incoming documents, and retrieving copies of paper protocol agreements from the TMF room for Apttus filing
• Collaborate with management to generate a central intake report on a daily and publish in a timely fashion
• Responsible for keeping DMT Master Inventory up to date and accurate
• Evaluate regulatory and Gilead business recordkeeping, archiving requirements, and organizational objectives and ensure Development Business Operations DMT is aligned with all
• Responsible for the continued maintenance of eTMF (GDAR) and Apttus contract filing
• File incoming documents and retrieve copies of paper protocol agreements from the TMF room for Apttus filing
• Ensure record filing is kept up to date is performed accurately by DMT members
• Work with management to develop and maintain quality assurance and control plans
• Responsible for monitoring the accuracy of the team's work by providing reports and metrics to the management team
• Potential lead of assigned meetings/projects and will mentor/help more junior staff with complex projects
• Develop and maintain department process guidance, training materials, policies and procedures, and other quality documents
• Define and manage processes associated with the storing, archiving, indexing, scanning, and classifying of clinical records
• Manage the off-site storage of records for Development Business Operations agreements and collaborate closely with the company Clinical Records team to ensure proper process is in place for off-site archival of paper agreements
• Collaborate and partner with the Information Technology (IT) GDAR Team, through stellar communication and solid project management. Resolve efficiently any issues encountered by collaborating with IT in the improvement of processes, procedures, and effective use of available information technologies
• Operate as the Subject Matter Expert (SME) in the electronic TMF (eTMF)
• Respond to internal and/or external information inquiries related to contract filing and records retention of those agreements; supports internal and external audits and inspections, including the provision of data on contract filing
• Contribute to the DMT mailbox by responding to daily email inquiries, review of incoming agreements for technical review and 30-day contemporaneous filing requirements and SLA turnaround time in eTMF (GDAR) and Apttus
• Participate in the development, implementation, and maintenance of internal systems and processes used to manage collections of agreements and filing of documents to GDAR and Apttus
• Track and maintain departmental metrics related to operational activities, the progress of contract filing and archive, quality measurements, and other variables. Develops appropriate tool sets for capturing metrics and generating reports.
• Responsible for the day-day activities associated with the quality check of clinical agreements and management of contract filing and archival
• Ensure appropriate documentation is completed to track the archival of files
• Support Development Business Operations Functional Teams and Clinical Operations Study Teams in understanding TMF-related responsibilities, requirements, and expectations
• Manage Development Business Operations TMF protocol list for legacy and active protocols and Development Business Operations TMF Comprehensive Review Trackers and Agreements Missing in TMF
• Provide management with DMT metrics; completeness and quality of TMF documentation and content, including the percent completeness and risk level of outstanding items on a periodic and/or ad-hoc basis as requested by management

Qualifications / Requirements
• 3-5 plus years of relevant experience
• BA/BS required
• 3+ years of data science experience with common data science toolkits and data visualization tools
• Expert in Client programs including, but not limited to, MSWord, PowerPoint, Visio, Access, and Excel
• 5 plus years of project management experience with PMP preferred
• 3 plus years of Clinical Research Associate (CRA) or relevant records management/ TMF management experience equivalent experience preferred
• Exemplary interpersonal skills with a proven demonstration
• Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management