.We are seeking an experienced and highly motivated Senior Centralized Study Specialist to join our team. This role involves managing clinical systems, supporting study documentation, ensuring compliance, and providing leadership and mentorship to junior team members. The successful candidate will play a pivotal role in the successful execution of clinical trials and contribute to process improvement initiatives.Key Responsibilities:Clinical Systems Management:Manage clinical systems, including CTMS milestone updates at Site/Country/Protocol levels.Manage and review study documents and support eTMF management.Manage internal/external communications by publishing and distributing newsletters, memos, and global communication under the guidance of the PM team.Create study plans and templates, including drafting and final formatting of slide decks for meetings, monitoring plans, etc.Data Review:Follow up with CRAs for resolution of outstanding issues/action items related to assigned tasks.Perform Associate Lead/Lead role for assigned projects.Draft and send study-specific reports as per study team instructions.Collaborate with Data Management and Programming teams for reports and communication of data review-related tasks.Initiate standardization of processes across different studies within data review.Perform quality reviews and suggest metrics improvements for data review tasks.Train, coach, and mentor new team members on all data review-related tasks.Perform other data review-related tasks as instructed by the project team and manager.Document Review:Review Initial/Amended Investigator Packages for regulatory compliance before granting green light for site patient enrollment.Review Core/Country/Site Informed Consent Forms for compliance with sponsor and regulatory requirements, and GCP guidelines.Review patient recruiting materials (advertisements) for compliance with sponsor, regulatory requirements, and GCP guidelines.Review Core Protocols for thoroughness, completeness, and GCP compliance.File informed consent forms, patient recruiting materials, and Investigator Package approval documentation in TMF and eTMF.Draft Investigator Package Plans documenting required quality of documents included in Investigator Packages with manager oversight.Provide input for CAPAs related to document review activities.Review CSSP Country and Site Document Review activities to ensure regulatory compliance and adherence to departmental processes.General Responsibilities:Follow all applicable departmental SOPs and Work Instructions.Complete required trainings within specified timelines.Create, review, and revise training materials and plans to support departmental training requirements.Create, review, or revise SOPs or Work Instructions to align with process or tool modifications.Manage day-to-day tasks ensuring quality and productivity.Generate monitoring processes to ensure trainee competence.Manage project and technical documentation appropriately