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Sitero LLC

8 Job openings at Sitero LLC
Senior Software Engineer Bengaluru, Karnataka 5 years INR Not disclosed On-site Full Time

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title : Senior Software Engineer Location : Bangalore, Karnataka ESSENTIAL DUTIES AND RESPONSIBILITIES Design, develop, test, debug, document software, and create /enhance existing components to ensure that software meets business needs Conduct design and code reviews to ensure code developed meets coding best practices guidelines, unit testing, security, and scalability and maintainability guidelines Deploy and maintain enterprise level Applications/Systems Collaborate with other team members, business stakeholders and product owners, both inside and outside the team Demonstrate application features and fixes with product management and users Mentor junior team members on procedures and technical standards Troubleshoot and support deployed systems Attend and participate in applicable company-sponsored training Maintain a strong understanding of software development trends and technology Maintain a strong understanding of the regulatory requirements applicable to software development in clinical trials EDUCATION AND EXPERIENCE REQUIRED: Bachelor’s degree in computer science, strongly preferred Minimum of 5+ years’ experience in Angular with a WebAPI Backend Experience with Microsoft SQL Server or SQL Azure. Experience with an Agile development process Experience with .net Framework and C# Strong interpersonal and communication skills, both verbal and written. Experience identifying and troubleshooting software problems. Strong organization skills and ability to prioritize and meet deadlines Experience conducting process re-engineering and improving costs/quality. COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Full Time, Permanent COMMITMENTS: Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed. Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Medical Reviewer - Aggregate Report Bengaluru, Karnataka 1 years None Not disclosed On-site Full Time

Medical Reviewer-Drug Safety Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title : Medical Reviewer Location : Mysore-Hybrid Function : Drug Safety Services ESSENTIAL DUTIES AND RESPONSIBILITIES: Oversee overall Pharmacovigilance (PV) and risk management activities. Review all appropriate data for product specific reports. Provide draft and review (carried out by separate individuals) all single/aggregate/cumulative medical assessments/benefit risk assessments for safety reports. Provide medical oversight white creating draft reports based on the approved SOP/WI process. Coordinate internal review process and finalize draft reports from medical point of view. Assist medical writer in addressing all comments from client and finalize. Should review the finalized report even if participated in assisting medical writer. Provide expert guidance in PV and Aggregate reporting areas. Coordinate all post marketing regulatory reporting and PV activities for assigned products to be carried out by Sitero aggregate reporting team. Preparation of sections of medical significance/inputs for aggregate safety reports such as PSUR, PBRER, Periodic Adverse Drug Experience Report (PADER), Summary Bridging Report, Addendum to Clinical Overview, DSUR, RMP, and addendum to PSUR. Responsible for the medical assessment, recommendation, and conclusion section of the Aggregate Safety Reports. Prepare and review responses to adhoc regulatory queries. Appropriate scientific interpretation of relevant information for inclusion into drug safety documents, prepare and write analytical aggregate reports and other drug safety medical documents. Creating all documents in accordance with applicable Standard Operating Procedure (SOPs), conventions, and regulatory requirements. Planning, organizing, and managing daily work to meet service level timelines and deliverables. EDUCATION AND EXPERIENCE REQUIRED: 1-3 years’ experience in Clinical Practice required. 1+ yr of experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products is preferable. Medical Degree (MBBS or higher) from recognized medical school. COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Permanent, Full Time COMMITMENTS: Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed. Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Assistant Manager - FP&A karnataka 3 - 7 years INR Not disclosed On-site Full Time

As an Assistant Manager/Manager - FP&A at Sitero, you will play a crucial role in the finance function by ensuring accurate financial planning and analysis. Your primary responsibilities will include preparing monthly MIS reports and other key performance indicators (KPI) metrics. You will be involved in developing and enhancing budgeting, financial projections, and operational forecasts to support the annual operation plan and budget finalization process. In this role, you will collaborate closely with business unit (BU) leaders to analyze BU profitability, drive decision-making through data analytics, and enhance overall profitability. Tracking various operational and financial KPIs, such as variance analysis, project profitability, and utilization rates, will be essential to ensure business success. Moreover, you will be responsible for revenue recognition in compliance with contractual agreements and preventing revenue leakages on a monthly basis. Working in coordination with the accounting team, you will assist in month-end closing activities to accurately accrue costs and revenues. Additionally, you will support the annual statutory audit process by addressing revenue-related queries and tracking order bookings and backlog forecasts regularly. Ensuring timely invoicing in alignment with contracts, mapping appropriate material codes for revenue recognition, and conducting ad-hoc financial analysis will be part of your responsibilities. As an integral part of the finance team, you will implement business intelligence tools and dashboard reports to enhance reporting efficiency. Collaboration with cross-functional teams, including Legal, Sales, and other support functions, will be essential to facilitate data flow for reporting and analysis purposes. You will also lead automation projects within the finance function to drive process efficiency and accuracy. The ideal candidate for this role should have 3-5 years of core FP&A experience, along with an MBA/CA or any other relevant professional qualification. This position offers a full-time, permanent employment opportunity with standard working hours of 40 hours per week, Monday to Friday, with additional hours as needed. Flexibility to work in shifts when required is expected to meet business demands. Join Sitero as an Assistant Manager/Manager - FP&A to contribute to innovative financial solutions and drive business success through effective financial planning and analysis.,

Operations Associate II Bengaluru, Karnataka 3 - 5 years None Not disclosed On-site Full Time

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Operations Associate II Location: Bangalore, Karnataka (Hybrid) Function: Service Delivery – Site and Patient Payments ESSENTIAL DUTIES AND RESPONSIBILITIES: Primary Responsibilities Support the operational implementation and ongoing investigator payment services for Payments projects or programs Support the creation and maintenance of vendor, site, and Principal Investigator (PI) records, bank setup entries, and user management Analyze clinical trial agreements, study protocols, and contract budgets, and support the review of contract budgets and the import of contracts Provide support for ongoing payment transactions, invoicing process, batch processing services, payment settlement, and query resolutions, in accordance with contractual Service Level Agreements Use strong critical thinking and problem-solving skills to assist project managers, operations lead, and other team members in resolving payment and other work-related issues Work well independently as well as collaboratively in a team with strong communication skills to ensure the project manager and project stakeholders are aware of the status of operational activities including successful completion of deliverables Participate in project team meetings, execute project deliverables on time, and provide status updates in implementations of Site and Patient Payments from project kickoff to study closeout Make final decisions on internal team discussions or escalate problems to the appropriate management personnel Manage expectations and deliverables on a client-by-client basis Provide excellent customer service at all times during all interactions with customers Maintains Quality Service and Departmental Standards by Contributing to the development and maintenance of the Site and Patient Payments product roadmap resulting in the production of new features or enhancements to existing products with product management Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”) Establishing and enforcing departmental standards Reviewing and updating company SOPs related to Site and Patient Payments Secondary Responsibilities Contributes to team effort by Exploring new opportunities to add value to organization and departmental processes Helping Payments Project Managers to accomplish deliverables Performing other duties as assigned and deemed necessary Maintains Technical Knowledge by Attending and participating in applicable company sponsored training EDUCATION AND EXPERIENCE REQUIRED: Education: Bachelor’s degree in business, finance, technology/software development area preferred Experience: 3-5 years of successful experience in the Operations Associate role or other equivalent investigator payments experience required Experience in invoice processing preferred Experience in contract entry accuracy, transaction processing, and client satisfaction preferred Background knowledge, understanding, or experience in clinical trial research field is highly desirable Additional skill set: Excellent customer service, documentation, and organizational skills Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong computer skills, including MS Office suite Ability to work in a collaborative group setting and independently and to adjust to changing priorities Ability to manage multiple priorities well and error-free Ability to project and maintain a professional and positive attitude Working conditions: Travel: 0-25% Lifting: 0-20lbs Other: Computer work for long periods of time COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Full Time, Permanent COMMITMENTS: · Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed. · Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Medical Reviewer - Aggregate Report Bengaluru, Karnataka 1 years None Not disclosed On-site Full Time

Medical Reviewer-Drug Safety Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title : Medical Reviewer Location : Mysore-Hybrid Function : Drug Safety Services ESSENTIAL DUTIES AND RESPONSIBILITIES: Oversee overall Pharmacovigilance (PV) and risk management activities. Review all appropriate data for product specific reports. Provide draft and review (carried out by separate individuals) all single/aggregate/cumulative medical assessments/benefit risk assessments for safety reports. Provide medical oversight white creating draft reports based on the approved SOP/WI process. Coordinate internal review process and finalize draft reports from medical point of view. Assist medical writer in addressing all comments from client and finalize. Should review the finalized report even if participated in assisting medical writer. Provide expert guidance in PV and Aggregate reporting areas. Coordinate all post marketing regulatory reporting and PV activities for assigned products to be carried out by Sitero aggregate reporting team. Preparation of sections of medical significance/inputs for aggregate safety reports such as PSUR, PBRER, Periodic Adverse Drug Experience Report (PADER), Summary Bridging Report, Addendum to Clinical Overview, DSUR, RMP, and addendum to PSUR. Responsible for the medical assessment, recommendation, and conclusion section of the Aggregate Safety Reports. Prepare and review responses to adhoc regulatory queries. Appropriate scientific interpretation of relevant information for inclusion into drug safety documents, prepare and write analytical aggregate reports and other drug safety medical documents. Creating all documents in accordance with applicable Standard Operating Procedure (SOPs), conventions, and regulatory requirements. Planning, organizing, and managing daily work to meet service level timelines and deliverables. EDUCATION AND EXPERIENCE REQUIRED: 1-3 years’ experience in Clinical Practice required. 1+ yr of experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products is preferable. Medical Degree (MBBS or higher) from recognized medical school. COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Permanent, Full Time COMMITMENTS: Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed. Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Senior Software Engineer Bengaluru, Karnataka 5 years None Not disclosed On-site Full Time

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title : Senior Software Engineer Location : Bangalore, Karnataka ESSENTIAL DUTIES AND RESPONSIBILITIES • Design, develop, test, debug, document software, and create /enhance existing components to ensure that software meets business needs • Conduct design and code reviews to ensure code developed meets coding best practices guidelines, unit testing, security, and scalability and maintainability guidelines • Deploy and maintain enterprise level Applications/Systems • Collaborate with other team members, business stakeholders and product owners, both inside and outside the team • Demonstrate application features and fixes with product management and users • Mentor junior team members on procedures and technical standards • Troubleshoot and support deployed systems • Attend and participate in applicable company-sponsored training • Maintain a strong understanding of software development trends and technology • Maintain a strong understanding of the regulatory requirements applicable to software development in clinical trials EDUCATION AND EXPERIENCE REQUIRED: • Bachelor’s degree in computer science, strongly preferred • Minimum of 5+ years’ experience in - Angular with a WebAPI Backend - Experience with Microsoft SQL Server or SQL Azure. - Experience with an Agile development process - Experience with .net Core and C# • Strong interpersonal and communication skills, both verbal and written. • Experience identifying and troubleshooting software problems. • Strong organization skills and ability to prioritize and meet deadlines • Experience conducting process re-engineering and improving costs/quality. COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Full Time, Permanent COMMITMENTS: · Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed. · Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Operations Associate II Bengaluru, Karnataka 0 - 5 years None Not disclosed On-site Full Time

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Operations Associate II Location: Bangalore, Karnataka (Hybrid) Function: Service Delivery – Site and Patient Payments ESSENTIAL DUTIES AND RESPONSIBILITIES: Primary Responsibilities Support the operational implementation and ongoing investigator payment services for Payments projects or programs Support the creation and maintenance of vendor, site, and Principal Investigator (PI) records, bank setup entries, and user management Analyze clinical trial agreements, study protocols, and contract budgets, and support the review of contract budgets and the import of contracts Provide support for ongoing payment transactions, invoicing process, batch processing services, payment settlement, and query resolutions, in accordance with contractual Service Level Agreements Use strong critical thinking and problem-solving skills to assist project managers, operations lead, and other team members in resolving payment and other work-related issues Work well independently as well as collaboratively in a team with strong communication skills to ensure the project manager and project stakeholders are aware of the status of operational activities including successful completion of deliverables Participate in project team meetings, execute project deliverables on time, and provide status updates in implementations of Site and Patient Payments from project kickoff to study closeout Make final decisions on internal team discussions or escalate problems to the appropriate management personnel Manage expectations and deliverables on a client-by-client basis Provide excellent customer service at all times during all interactions with customers Maintains Quality Service and Departmental Standards by Contributing to the development and maintenance of the Site and Patient Payments product roadmap resulting in the production of new features or enhancements to existing products with product management Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”) Establishing and enforcing departmental standards Reviewing and updating company SOPs related to Site and Patient Payments Secondary Responsibilities Contributes to team effort by Exploring new opportunities to add value to organization and departmental processes Helping Payments Project Managers to accomplish deliverables Performing other duties as assigned and deemed necessary Maintains Technical Knowledge by Attending and participating in applicable company sponsored training EDUCATION AND EXPERIENCE REQUIRED: Education: Bachelor’s degree in business, finance, technology/software development area preferred Experience: 3-5 years of successful experience in the Operations Associate role or other equivalent investigator payments experience required Experience in invoice processing preferred Experience in contract entry accuracy, transaction processing, and client satisfaction preferred Background knowledge, understanding, or experience in clinical trial research field is highly desirable Additional skill set: Excellent customer service, documentation, and organizational skills Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong computer skills, including MS Office suite Ability to work in a collaborative group setting and independently and to adjust to changing priorities Ability to manage multiple priorities well and error-free Ability to project and maintain a professional and positive attitude Working conditions: Travel: 0-25% Lifting: 0-20lbs Other: Computer work for long periods of time COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Full Time, Permanent COMMITMENTS: · Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed. · Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Medical Reviewer - Aggregate Report karnataka 1 - 5 years INR Not disclosed On-site Full Time

As a Medical Reviewer at Sitero, you will play a crucial role in overseeing Pharmacovigilance (PV) and risk management activities related to drug safety services. Your responsibilities will include reviewing data for product-specific reports, providing medical oversight for draft reports, coordinating internal review processes, and finalizing reports from a medical perspective. You will collaborate with medical writers to address client comments and ensure the accuracy and compliance of all safety reports. Additionally, you will offer expert guidance in PV and aggregate reporting areas, manage post-marketing regulatory reporting and PV activities for assigned products, and prepare sections of medical significance for various aggregate safety reports. Your role will involve providing medical assessments, recommendations, and conclusions for Aggregate Safety Reports, as well as responding to adhoc regulatory queries with appropriate scientific interpretation. To excel in this position, you should have 1-3 years of clinical practice experience, including at least 1 year in Drug Safety and Pharmacovigilance within a pharmaceutical, biotech company, CRO, or regulatory agency. A Medical Degree (MBBS or higher) from a recognized medical school is required for this role. Your daily tasks will involve creating drug safety documents in accordance with SOPs and regulatory requirements, managing work efficiently to meet service level timelines, and ensuring the quality and accuracy of all medical documents. This role is permanent and full-time, with standard working hours of 40 hours per week, Monday to Friday, and a willingness to work in shifts when needed. Join Sitero's dynamic team and contribute to the safety and well-being of stakeholders in the clinical research community through your expertise and commitment to excellence in drug safety services.,