Skill required: Clinical Data Services - Clinical eTMF Management
Designation: Clinical Data Svs Manager
Qualifications:Bachelor of Pharmacy/Master of Pharmacy
Years of Experience:15+ years
Language - Ability:English - Advanced
About Accenture
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What would you do? Role Name: eTMF Operations and Service Delivery Lead Process related Roles & Responsibilities will be as follows: 1) Be a Functional Subject Matter Expert and Lead a team of 100+ eTMF experts delivering eTMF Operational services to the client in Veeva Vault Platform as well as legacy platforms and databases 2) Develop and implement strategic plans for the eTMF function, aligning with overall company objectives. 3) Oversee the implementation, maintenance, and enhancement of the eTMF system 4) Ensure that the eTMF system is compliant with regulatory requirements and industry standards. 5) Monitor and evaluate eTMF system performance, identifying areas for improvement 6) Ensure that all clinical trial documentation is maintained in accordance with GCP, ICH guidelines, and applicable regulatory requirements. 7) Be a Functional Subject Matter Expert and Lead a team of 100+ eTMF experts delivering eTMF Operational services to the client in Veeva Vault Platform as well as legacy platforms and databases 8) Deep hands-on expertise with eTMF Technical QC and eTMF Sample based QC and awareness of the eTMF priorities during different eTMF Lifecycle stages such as Inspection Readiness / eTMF Migrations / different health authority requirements etc. 9) Closely interact with the Pharmaceutical client and execute eTMF migrations plans related to movement of eTMF documents from legacy platform to Veeva Vault platform in a timely manner - create and execute operational plan for delivering on client requirements through the Accenture delivery team 10) Set-up day to day operational metrics to report the status of eTMF backlog of documents across different databases and platforms. Be a part of and Lead all client operational and governance meetings to report back the status of daily volume accomplishments as well as plan for the future delivery and forecasts 11) Deep understanding of the clinical trial lifecycle from study start-up to close-out 12) Experience with preparing and managing regulatory submissions to FDA, EMA, and other global health authorities 13) Be the Single Point of Contact for the Pharmaceutical client to understand their day-to-day requirements related to eTMF Operations such as Priorities related to Headquarters, Country, Sites and plan for the execution to be done by the Accenture delivery team
What are we looking for? 14) Drive process improvements & optimization related to eTMF filing of document, quality. review & metrics generation 15) Must have exposure to building business case related to the development and deployment of technologies such as RPA / AI / GenAI on Veeva Vault platform, as necessary to cut down on the human interventions in the process and drive improvements 16) Set-up, establish and manage operational metrics related to KPIs / SLAs and other process level core metrics to be reported to the Pharmaceutical client in the pre agreed frequency. Work on CAPA measures, as needed to ensure full proof delivery of eTMF processes 17) Closely watch over and monitor the available capacity within the Accenture eTMF Delivery team to meet the clients eTMF processing requirements and flag any risks & issues to Accenture Senior Management for timely support and resolution 18) Lead and manage audit expectations from both internal as well as external auditors. Must be able to take the lead in explain the process details and showcase the required artifacts during any audit / inspection 19) Conduct interviews and assessments to add new team members to cater to attrition and other business growth opportunities People and Talent Management Responsibilities will be as follows: 1) This role will have the below functional layer – eTMF Line Managers, eTMF Managers & eTMF Analysts. Clearly define and operate with an eTMF team reporting structure that has the different layers 2) To set up clear accountabilities and role boundaries for the above roles for the team members to be successful in their day-to-day client delivery 3) Ensuring that there is a proper succession and career progression plan available for Key roles and individuals within the team and the same is practiced to provide the best learning & career growth experience to the team members 4) Manage performance evaluation cycle for the entire eTMF delivery team
Roles and Responsibilities: Educational & Experience Requirements will be as follows: 1) Overall experience of 15+ years with at least 5 to 6 years in a leadership role leading eTMF Operations for any Tier-1 Pharmaceutical client 2) Prior experience related to running large eTMF operations spanning across different shift timings / different delivery centers geographically 3) Should have worked on new business RFP / RFI opportunities related to eTMF operations and suggested ways of process improvements and optimization