Senior Manager, System Operations

Job Description: Help guide report strategy, help determine important safety concerns and review medical and medical safety content that will be included or discussed in the report, including but not limited to safety signals, health authority requests, safety-related literature, adverse event case reviews, benefit-risk assessments, and overall medical assessments and conclusions. Work in collaboration with contributing team members, particularly with the reports assigned to the Global Risk Assessment and Safety Physician. Review all stages of the report that are assigned during the report authoring process, record their recommended revisions, and indicate completion of their reviews in the corresponding systems. Key Responsibilities: Provide medical and scientific judgment in the evaluation of data pertaining to the efficacy and safety of Client products including, but not limited to, PBRER-PSURs and benefit-risk evaluations Review and contribute to strategy discussions, including determination of the important safety concerns and review of draft/final data, HA feedback topics, signals, and benefit-risk evaluation. Coordinate with Global Risk Assessment and Safety Physicians regarding PBRER steps and hand-offs and collaborate with other members of the report authoring team. Review the drafts and final reports as assigned and provide feedback, which may include pre-initial, drafts, drafts, final drafts, and final reports as assigned. Experience/Qualifications: Requirement: Medical Physician Technical Skills: the ability to analyze, interpret, and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential. Attention to detail: diligence in record-keeping and records organization, ability to manage high workload and critical issues, computer literate and proficiency in MS Office applications. Interpersonal skills: team player, displays initiative, strong communication, and presentation skills. I

Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS; Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan; Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts; Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) Create electronic submission packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision. Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges; Serve as point of contact (POC) of programming with statisticians for statistical input and analysis interpretation; Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiatives. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams; Review draft and final production deliverables for project to ensure quality and consistency. Work with global team or sponsors to coordinate project deliverables, timelines and resources. Skills and Responsibilities: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Expert level in applying concept in Artificial Intelligence and Machine Learning in real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical tria

Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS. Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. Proficient in analyze information and develop innovative solutions to programming and data analysis challenges; Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiative. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams. Review draft and final production deliverables for project to ensure quality and consistency. Skills and Qualifications: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 4+ years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. Good understa

At ClickUp, we're building the future of work: the first truly converged AI workspace unifying tasks, docs, chat, calendar, and enterprise search, all supercharged by context-driven AI. We are an AI-native company. Every team member is expected to leverage AI daily, and we evaluate AI fluency as part of our hiring process. Join us and help redefine what's possible. 🚀 ClickUp is looking for a Senior Partner Sales Support Specialist based in the Philippines. This role is a critical enablement function supporting our Enterprise Partner Managers worldwide. You’ll be the operational backbone that keeps our partner sales motion running smoothly, helping Enterprise Partner Managers close deals faster by handling sales support activities across all regions. This is a high-impact, globally-scoped role that sits at the intersection of partner operations, sales enablement, and deal support. The candidate will be customer and partner-facing (on Zoom). The role: Provide day-to-day partner support to Enterprise Partner Managers across all regions (AMER, EMEA, APAC, LATAM), including deal registration processing, pipeline management, and opportunity tracking. Own and process smaller partner-sourced deals end-to-end, managing them through internal systems to ensure fast, accurate closure. Manage internal system administration (Salesforce, deal desk, CPQ) to remove friction from the partner deal cycle, including quote generation, order processing, and approval routing. Coordinate and manage partner onboarding logistics, ensuring new partners are set up in systems, trained on tools, and equipped to transact effectively. Maintain partner CRM data hygiene, ensuring accurate pipeline inputs, deal stage progression, and timely reporting for leadership. Act as the internal point of contact for partner deal escalations, liaising with Deal Desk, Legal, Finance, and RevOps to unblock and accelerate closures. Process MDF (Market Development Fund) submissions, track claims, and ensure timely

At ClickUp, we're building the future of work: the first truly converged AI workspace unifying tasks, docs, chat, calendar, and enterprise search, all supercharged by context-driven AI. We are an AI-native company. Every team member is expected to leverage AI daily, and we evaluate AI fluency as part of our hiring process. Join us and help redefine what's possible. 🚀 We’re looking for a Technical Implementation Account Manager (TAM) to support our customers as a trusted partner and problem-solver, blending strong relationship management with a growing understanding of ClickUp’s platform and capabilities. This role sits at the intersection of customer success, solution strategy, and technical enablement, contributing to long-term growth, adoption, and measurable business outcomes. This role operates in an AI-native environment, and we expect TAMs at this level to use AI tools as a daily multiplier across account preparation, workflow analysis, solution design, follow-through, and customer enablement. TAMs at this level manage a defined book of business and own day-to-day execution for their accounts, while working closely with more senior TAMs and cross-functional partners on complex initiatives. You’ll use established frameworks, playbooks, and templates to guide onboarding and adoption, monitor account health, and help ensure stakeholders see continuous value throughout their lifecycle. At the L04 level, success means not just understanding AI-enabled features, but showing sound judgment in when and how to use AI to improve execution quality, speed, and customer outcomes. Technical Account Managers are responsible for delivering measurable value and driving meaningful business outcomes across their customer portfolio by focusing on: Customer Enablement & Onboarding: Supporting customers through onboarding and implementation for assigned customers, following established discovery frameworks and implementation plans. Account Health & Engagement: Monitoring a

Secure Every Identity, from AI to Human Identity is the key to unlocking the potential of AI. Okta secures AI by building the trusted, neutral infrastructure that enables organizations to safely embrace this new era. This work requires a relentless drive to solve complex challenges with real-world stakes. We are looking for builders and owners who operate with speed and urgency and execute with excellence. This is an opportunity to do career-defining work. We're all in on this mission. If you are too, let's talk. At Okta, we believe in simplifying the journey for our sellers and our customers. Our Deal Operations Team is the engine that drives this mission, partnering closely with Sales to structure, navigate, and close complex commercial contracts. Operating within the Quote-to-Cash team under the Finance Operations umbrella, we bridge the gap between policy integrity and deal velocity. We are looking for an experienced Operations professional who thrives in a dynamic SaaS environment. In this role, you will leverage your expertise in SaaS subscription structures to drive friction-free, seamless booking processes. At the same time, you will serve as a key gatekeeper, validating that all commercial structures map cleanly to Okta’s baseline corporate finance metrics. If you want to deeply analyze business friction points and collaborate across teams to build a more seamless, compliant operational blueprint, this is the role for you. In this role, your responsibilities included but are not limited to: Supports all commercial related activities including, but not limited to, deal structuring with deals under $100k, contract creation, pricing guidance, review approval, contract management and providing support to field sales for quoting purposes. Ensures deals are structured and processed efficiently and align to company policies. Reviews, interprets and confirms contract terms and conditions; works closely with finance and legal teams to ensure all contract