Remote - East Coast - USA Mission The Senior Clinical Documentation Manager acts as point person in the organization providing day-to-day support across the organization in the management of the trial master file (TMF) and in the use of the eTMF system. They will support established processes and address any questions or issues that arise through to resolution in a timely manner. Reporting Relationship The Senior Clinical Documentation Manager will report to the Director, Clinical Documentation and Site Management, or designee. Duties and Responsibilities Partners with the Clinical Operations (CO) and Site Management (SM) teams for assigned trials to ensure adherence to TMF management processes to achieve a complete, timely, inspection-ready, and high quality TMF on an ongoing basis. • Facilitate the creation and maintenance of the study specific TMF Management Plan and the TMF Index. • Work with TMF Functional Owners and their delegates in the management of TMF records. • Manage TMF records into the eTMF system as a delegate of functional owners. • Manage communications and queries in the eTMF system. • Facilitate the conduct of periodic quality reviews of the study specific TMF and monitors to ensure issues are brought to resolution. Perform quality reviews of the TMF. • Oversight of the TMF quality check vendor per the TMF Management plan, working with vendor to address issues to acceptable resolution. • Review study specific TMF management status and develop target goals using the eTMF system reports and metrics. • Monitor TMF management-related process steps and identifies areas that need attention. Communicates these needs to the Director, Clinical Documentation & Site Management or designee. • Communicate with TMF Functional Owner, any issues identified and offering assistance and support to ensure timely, accurate, and high-quality management of TMF records. • Travel to clinical trial sites as needed to assist the CSMs with reconciliation the eTMF with the Investigator Site Files (ISFs). • Provide input on the improvement of TMF management related processes. Assists in preparation and maintenance of manuals, quick reference guides, training materials, procedures, and other procedural documents. Takes on special projects, with oversight, to improve the process of TMF management at Beacon Therapeutics. • Supports activities as assigned and overseen by Director, Clinical Documentation & Site Management or designee, during the preparation and conduct of internal and external audits and inspections, including contribution to development and tracking to closure of any CAPA activities. • May perform job responsibility-specific User Acceptance Testing of the eTMF system when periodic system updates are executed under the direction of the eTMF System Owner or delegate. Other duties as assigned. This job description is subject to change at any time. Educational Qualifications A bachelor’s degree (scientific discipline preferred) with at least ten (10) years of clinical research experience or medical/nursing certification with over fourteen (14) years of clinical research experience. Additional Qualifications • Twelve (12) preferred years of clinical research experience or an equivalent combination of advanced degree and experience in a scientific discipline acceptable. • Includes at least three (3) years’ of TMF Management experience with an intermediate understanding of the documentation created in support of the clinical study including use of eTMF systems and basic understanding of records management requirements in Drug Development/ICH-GCP and knowledge of scanning and indexing principles, relational databases. • Proficiency with eTMF system and TMF record management practices. • Knowledge of the CDSIC TMF Reference Model • In-depth understanding of ICH/GCP guidelines and FDA regulations as they pertain to the operational aspects of clinical studies and the management of trial master file content. • Ability to communicate with diverse customers and provide a high level of service and value-added products; demonstrated customer focus is required. This position requires the ability to partner with co-workers, internal customers, external vendors, and the ability to evaluate, identify, and influence new process required or established process improvements. • Ability to identify and respond to problems in efficient and timely manner. • Ability to handle complex projects. • Knowledge of cross functional roles and responsibilities. • Demonstrate strong problem solving and judgement skills. • Excellent written and verbal communication skills. • Understanding/working knowledge of Microsoft Word, Excel and Microsoft Project. Physical Requirements Physical demands: (check one) • sedentary (< 10 lbs.) Physical activity: (check all that apply) • repetitive motion • standing • typing/grasping • walking • hearing Visual acuity (preparing/analyzing data, transcribing, reading, and writing) Working conditions (indoor office environment) Supervisor Responsibilities This position does not require previous supervisory experience.