1157 Clinical Research Jobs - Page 34

We are seeking a highly skilled Clinical Statistician with extensive experience in CDISC-compliant statistical programming. The ideal candidate will be responsible for providing statistical support for individual clinical trials as we'll as integrated summaries of safety (ISS) and efficacy (ISE). This role requires a deep understanding of clinical trial design, data analysis, and regulatory requirements. Key Responsibilities: Develop and execute statistical analysis plans for clinical trials. Perform statistical programming using SAS and R, ensuring compliance with CDISC standards. Conduct integrated analyses for ISS and ISE, ensuring consistency and accuracy across studies. Leverage experience (if applicable) to support the preparation of datasets and documentation for regulatory submissions, such as ISS/ISE, in line with global standards (eg, FDA, EMA) Generate tables, listings, and figures (TLFs) for clinical study reports (CSRs) and regulatory submissions. Collaborate with cross-functional teams, including clinical research, data management, and medical writers, to ensure accurate and timely delivery of statistical outputs. Provide statistical input for study design, protocol development, and sample size calculations. Review and validate statistical deliverables to ensure quality and compliance with regulatory guidelines. Stay current with industry trends and advancements in statistical methodologies. Contribute to process optimization and development of templates, or standardized processes to enhance team efficiency and consistency. Qualifications: Masters or Ph.D. in Statistics, Biostatistics, or a related field. Minimum of 5 years of experience in clinical statistics, with a focus on CDISC-compliant statistical programming. Proficiency in SAS and R programming, in aim of increasing efficiency. Experience with integrated summaries of safety (ISS) and efficacy (ISE). Strong understanding of clinical trial design, data analysis, and regulatory requirements. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills, with the ability to guide diverse groups of people through complex processes in a team environment. Ability to manage multiple projects and meet deadlines in a fast-paced environment. Preferred Qualifications: Experience in the pharmaceutical or biotechnology industry. Knowledge of other programming languages (eg, Python) is a plus. Familiarity with regulatory submission processes (eg, FDA, EMA). Experience in management, Agile/scrum-type experience is a plus. Experience of working with international teams remotely is a plus.

-Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting compliance with timelines. About the Role Major accountabilities: Lead statistical programming activities for several studies or drive the implementation of data analytics reports -Make decisions and propose strategies at study or project level. May act as functional manager for local associates including providing supervision and advice on functional expertise and processes. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical aspects (timelines, scope, resource plan), eg as representative in study or project-level team. Ensure project-level standardization -Provide and implement programming solutions; ensure knowledge sharing. Act as expert in problem-solving aspects. Ensure timely and quality development and validation of datasets and outputs for regulatory submissions/interactions, safety reports, publications, post-marketing activities etc -Leads/co leads novel projects within the team -Generates innovative ideas within own team and /or project team /functional community -Recognizes and leverages innovation opportunities for own team across projects -Mentors and inspires others to solve problems -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across functional activities and deliverables. Adherence to Novartis policy and guidelines -Customer / partner feedback and satisfaction Minimum Requirements: Work Experience: Biostatistics. Clinical Research Phases. RD Portfolio Management. Statistical Programming. Data Management Systems. Regulatory Submissions. Innovative Analytical Technologies. Clinical Trial Design, Data Review Reporting. Skills: Classification Systems. Clinical Trials. Computer Data Storage. Computer Programming. Cross-Functional Teams. Data Analysis. Data Structures. Initiative. Programming Languages. Reporting. Statistical Analysis. Languages : English.

-Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. -Applicable to Clinical Scientific Expert IThe Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE I is a core member of the Clinical Trial Team (CTT) and may support program level activities as assigned. Major accountabilities: Implementing issue resolution plans; -Assist with program level activities (eg, tracking of program -Managing interactions with relevant line functions including data management, drug supply management, clinical development and/or Novartis Country Pharma Organizations; -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards. Proactive operational planning with effective contingency and risk mitigation plans. Applicable for Clincial Scientific Expert I: -Performing clinical data review and insights consistently and accurately which meets the Novartis quality standards, timelines, and is inspection ready. High quality contributions to study documents (eg protocol, ICF, clinical sections of CTA) -Clearly demonstrates Novartis Values and Behaviors (ie Innovation, Quality, Collaboration, Performance, Courage and Integrity. Minimum Requirements: Work Experience: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management. Skills: Clinical Research. Clinical Trial Protocol. Clinical Trials. Data Integrity. Learning Design. Lifesciences. Risk Monitoring. Trends Analysis. Languages : English.

To support the development, dissemination, and maintenance of Value Access deliverables for selected key strategic asset/s for a specific disease/condition. Deliverables: Indirect treatment comparison, Cost effectiveness models, budget impact models and their updates, and other activities as directed by clients across Novartis Key Responsibilities: Develop optimal knowledge and experience in Health Economic Modeling and Evidence Synthesis Develop and maintain the qualitative and/or quantitative deliverables as per the client requirements in accordance with the agreed standard process and timelines Liaise with clients on project schedule/planning of deliverables Ensure that the new associates/junior colleagues deliver quality deliverables by providing guidance and performing QC/review Support clients to conduct feasibility assessment and update indirect treatment comparisons as and when required Deliver adhoc trial data based statistical requests and activities Support the development of additional guidance and training materials (ie checklists, QA processes etc) Develop long-term, peer-level relationships with key clients Take responsibility and accountability to train, mentor, coach and also ensure functional development of new associates/junior colleagues within VA team Perform effective project management and stake-holder management Contribute to VA initiatives / work-streams Complies with and support group s project management tool, standards and policies. Maintains records for all assigned projects including archiving. Maintains audit, SOP and training compliance Essential Requirements: Undergraduate degree in a relevant scientific discipline plus graduate degree (Masters or PhD) in relevant discipline (including health economics, statistics, biostatistics, epidemiology, health services research, public health, or business management) Proficiency in English is a pre-requisite; while knowledge of other in-scope country languages would be an advantage Pharmaceutical domain knowledge MS-Office skills (MS-Excel, MS-Word, and MS-Power-point) 7+ years conducting Quantitative evidence synthesis or health economic modeling for pharmaceutical products in pharma industry, contract research organization, or academic institute; or experience in a closely related discipline within the pharma industry (eg clinical research, statistics, epidemiology, trial data analytics) Ability to work, prioritize, and drive projects independently.

To support the development, dissemination, and maintenance of Value Access evidence generation deliverables for selected key strategic asset/s for a specific disease/condition. Deliverables: Targeted literature review, systematic literature review, Global value dossier, publications, and other activities as directed by stakeholders. Key Responsibilities: Develop complete knowledge and experience in VA/ HEOR evidence generation Develop and maintain the qualitative and/or quantitative deliverables as per the client requirements in accordance with the agreed standard process and timelines Support clients to conduct HEOR evidence generation activities. Liaise with clients on project schedule/planning of deliverables Ensure that the new associates/junior colleagues deliver quality deliverables by providing guidance and performing QC/review Support the development of additional guidance and training materials (ie checklists, QA processes etc) Contribute to the continual improvement of the assigned deliverables and the guidance template Take responsibility and accountability to train, mentor, coach and also ensure functional development of new associates/junior colleagues within VA team Perform effective project management; Perform effective stake-holder management and ensure repeat projects / business Contribute to VA initiatives / work-streams Complies with and support group s project management tool, standards and policies. Maintains records for all assigned projects including archiving. Maintains audit, SOP and training compliance Essential Requirements: 7+ years conducting HEOR (health economic and outcomes research) evidence generation for pharmaceutical products in pharma industry, contract research organization, or academic institute; or experience in a closely related discipline within the pharma industry (eg clinical research, statistics, epidemiology, pricing analytics) Undergraduate degree in a relevant scientific discipline plus graduate degree (Masters or PhD) in relevant discipline (including health economics, epidemiology, health services research, public health, or business management) Proficiency in English is a pre-requisite; while knowledge of other in-scope country languages would be an advantage Pharmaceutical domain knowledge MS-Office skills (MS-Excel, MS-Word, and MS-Power-point) Ability to work, prioritize, and drive projects independently

-Responsible for all statistical programming/data review reporting and analytics development aspects of assigned studies or project-level activities. Acts as a key contributor in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Major accountabilities: Responsible for planning, monitoring, documenting of projects and analysis of information -Co-ordinate activities of all programmers either internally or externally assigned to the study/project work -Contribute to project level standards -Review and discuss data structures and participate in data review activities. Responsible for development of programming specifications of analysis datasets or user requirement documentation -Contributes to some cost center goals and objectives -Broadens technical knowledge via departmental activities, literature reading and experiential learning. May train junior. new team members -Skilled in collaboration across project team(s) -Responsible for quality control and audit readiness of all assigned statistical programming deliverables as we'll as accuracy and reliability of statistical analysis results -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across functional activities and deliverables. Adherence to Novartis policy and guidelines -Customer / partner feedback and satisfaction Minimum Requirements: Work Experience: Biostatistics. Clinical Research Phases. RD Portfolio Management. Innovative Analytical Technologies. Regulatory Submissions. Data Management Systems. Statistical Programming. Clinical Trial Design, Data Review Reporting. Skills: Clinical Trials. Computer Programming. Data Analysis. Programming Languages. Reporting. Statistical Analysis. Languages : English.

Working in partnership with the Client Engagement team, Medical Communications, and the Writing delivery team for a designated client group/therapeutic area (TA)/brand, this role will be responsible for delivering and supporting scientific excellence of Medical Communications services across their accounts Key Responsibilities: Prepares / supports the preparation of highly complex scientific documents to meet highest quality standards. Initiates, implements and champions process improvement techniques. Manages multiple projects across multiple brands and therapeutic areas. Defines and implements customer management strategies and tactics. Develops a Center of Excellence (CoE) for identified TA/disease area/deliverable. Provides strategic inputs to development and brand plans and assists in policy decision making as TA/disease/deliverable champion. Ideates and implements tactics to influence internal and external development environment. Complies with and support group s project management tool, standards, policies and initiatives. Commitment to Diversity Inclusion: : Essential Requirements: : Minimum science degree or equivalent, B.Sc./equivalent with 12 years Clinical Research (CR) experience, M.Sc./M.Pharm +10 years of clinical research (CR) experience Provides strategic inputs to development and brand plans and assists in policy decision making as TA/disease/deliverable champion. Desired Requirements: Thorough knowledge of Good Clinical practice. Demonstrated ability to establish effective working relationship in a matrix and multicultural environment. Demonstrated presentation and diplomacy skills. Strong customer-oriented mindset.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Key Accountabilities: Release deployment Assesses and analyses release components. Provides input to scheduling. Carries out the builds and tests in coordination with testers and component specialists maintaining and administering the tools and methods - manual or automatic - and ensuring, where possible, information exchange with configuration management. Ensures release processes and procedures are maintained. Service acceptance Engages with project management to confirm that products developed meet the service acceptance criteria and are to the required standard. Feeds into change management processes. System software Reviews system software updates and identifies those that merit action. Tailors system software to maximise hardware functionality. Installs and tests new versions of system software. Investigates and coordinates the resolution of potential and actual service problems. Prepares and maintains operational documentation for system software. Advises on the correct and effective use of system software. Programming software development Designs, codes, tests, corrects and documents complex programs and scripts and integration software services and subsequent iterations. Applies agreed standards and tools, to achieve well-engineered outcomes. Participates in reviews of own work and leads reviews of colleagues work. Systems integration build Defines the software modules needed for an integration build and produces a build definition for each generation of the software. Accepts completed software modules, ensuring that they meet defined criteria. Produces software builds from software source code for loading onto target hardware. Configures the hardware and software environment as required by the system being integrated. Produces integration test specifications, conducts tests and records and reports on outcomes. Diagnoses faults and records and reports on the results of tests. Produces system integration reports. Systems design Undertakes complete design of simple applications using simple templates and tools. Assists as part of a team on design of components of larger systems. Produces detailed designs including for example: physical data flows, file layouts, common routines and utilities, program specifications or prototypes, and backup, recovery and restart procedures. Methods and tools Provides advice and guidance to support adoption of methods and tools and adherence to policies and standards. Tailors processes in line with agreed standards and evaluation of methods and tools. Reviews and improves usage and application of methods and tools. Conformance review Conducts formal reviews of activities, processes, products or services. Collects, collates and examines records as part of specified testing strategies for evidence of compliance with management directives, or the identification of abnormal occurrences. Analyses evidence collated and drafts part or all of formal reports commenting on the conformance found to exist in the reviewed part of an information systems environment. Emerging technology monitoring Supports monitoring of the external environment and assessment of emerging technologies to evaluate the potential impacts and opportunities to the organization for new ways of working. Contributes to the creation of briefings and presentations, technology road mapping and the sharing of knowledge and insights about the relevance and potential value of new technologies to the organization. Specialist advice Actively maintains knowledge in one or more identifiable specialisms. Provides detailed and specific advice regarding the application of their specialism(s) (i.e. in an aspect of information or communication technology, technique, method, product or application area). Capacity management Monitors service component capacity and initiates actions to resolve any shortfalls according to agreed procedures. Applies techniques to control the demand upon a particular resource or service. Contributes to capacity modelling and planning. Supports the design of service component capacity. Incident management Prioritises and diagnoses incidents according to agreed procedures. Investigates causes of incidents and seeks resolution. Escalates unresolved incidents. Facilitates recovery, following resolution of incidents. Documents and closes resolved incidents according to agreed procedures. Other Carryout any other reasonable duties as requested. S kills: Excellent interpersonal, verbal and written communication skills and positive stakeholder management Demonstrates ability to present to small-medium sized audiences A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, including management of documentation Takes ownership and responsibility; shows initiative and self-confidence, is adaptable and is able to cope with changing and evolving priorities Must have the ability to work methodically in a fast-paced, time-sensitive environment Demonstrates problem solving and critical thinking skills and ability to work under pressure Willingness to work in a matrix environment and to value the importance of teamwork Awareness of the value and perception of your activities on your peers and wider team Ability to operate collaboratively within a global team environment A self-starter and able to work under own initiative Maintains an in-depth knowledge of specific specialism in the field and provides expert advice regarding the application showing leadership when researching and implementing new solutions Natural coach/mentor who leads by example with an approachable demeanor Knowledge and Experience: Azure PaaS IaaS VM setup, configuration, engineering development experience Experience in Microsoft Office 365 and PowerApps engineering desirable Understanding of CI/CD pipeline build, improvement, and management Hands on demonstrable experience with cloud infrastructure: Azure PaaS IaaS, PowerShell ARM Template Automation, Software Defined Networking, Virtual machine automation for Windows Server, Linux and associated infrastructure management layer automation Exposure to and maintenance of configuration management and orchestration tools Diagnosing and troubleshooting incidents, problems and service-outages in web applications and network services Exposure to system and application-level telemetry for large distributed micro services Cloud Architectures Understanding in building cloud services within regulated environments Azure Devops, Octopus Deploy, TeamCity, Jenkins, SonarQube, Git experience or knowledge of similar products also be useful Experience of robust and repeatable automation of third-party products into Azure IaaS (e.g., Oracle, Java, Tenable, etc.) Excellent knowledge of ITIL, Foundation certification is desirable Experience in Scrum Agile methodologies Microsoft Azure Certifications are desirable Education: Bachelor s Degree in a technical discipline (Software Engineering, Computer Science etc.) or a related study, or equivalent related experience English: Fluent Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Aster Pharmacy (India) is looking for Resident.Anaesthesiology.MIMS Hospital Calicut to join our dynamic team and embark on a rewarding career journey Administer anesthesia for surgeries and procedures Monitor patient response and vital signs Collaborate with surgical teams for safety Manage post-operative recovery and pain control

NATIONAL HOSPITAL is looking for NURSING TUTOR to join our dynamic team and embark on a rewarding career journey Develop and deliver nursing curriculum and training programs Mentor and guide nursing students in clinical practice Evaluate student performance and provide constructive feedback Stay updated with the latest nursing practices and standards Collaborate with healthcare professionals to enhance training programs

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Key Responsibilities Security Engineering Implementation Deploy, configure, and maintain security technologies, including firewalls, IDS/IPS, endpoint security, and XDR solutions. Work closely with IT and DevOps teams to integrate security into system and application architectures. Threat Detection Incident Response Monitor security alerts and investigate incidents to identify root causes and remediation actions. Support security operations teams in responding to threats and improving detection and response capabilities. Endpoint, Cloud, and Network Security Implement and manage security controls for endpoints, cloud environments, and networks. Work on securing hybrid cloud infrastructures and enforcing Zero Trust principles Vulnerability Patch Management Conduct security assessments and penetration tests to identify vulnerabilities. Work with IT teams to prioritize and apply security patches and remediations. Compliance Risk Management Assist in maintaining compliance with industry regulations (ISO 27001, GDPR, HIPAA). Participate in security audits, risk assessments, and policy development to strengthen the organization s security framework. Security Awareness Collaboration Work closely with internal teams to provide security guidance and training. Contribute to security awareness programs to enhance the organizations security culture. Functional Competencies (Technical knowledge/Skills) Strong knowledge of security frameworks (NIST, ISO 27001, CIS Controls). Hands-on experience with security tools such as firewalls, IDS/IPS, EDR, and XDR solutions. Understanding of cloud security in AWS, Azure, or GCP. Experience with vulnerability management and penetration testing. Knowledge of IAM, PAM, and Zero Trust security principles. Strong analytical skills and problem-solving capabilities. Effective communication skills to work with technical and non-technical teams. Experience, Education, and Certifications 9+ years of experience in cybersecurity, with hands-on expertise in security engineering. Bachelors degree in Computer Science, Cybersecurity, or a related field. Relevant certifications such as CISSP, CEH, OSCP, or equivalent are preferred. Experience in security operations, incident response, and vulnerability management. Strong understanding of regulatory and compliance requirements in cybersecurity. Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Job Description Summary The Accounts Payable Data Entry Specialist is responsible for processing all invoices received for payment and ensuring the timely processing with right coding details. Key Responsibilities Invoice Management Ensure all the invoices are reviewed and verified before processing. Invoices received on dedicated mailbox are actioned on timely and agreed TAT. Ensuring the invoices are verified using the 3-way matching principle. Data entry and Queries management From the allocated invoices ensure processing of the invoices as per the TAT on system and sent for approval. Manage the in-progress invoices and ensure the approvers are approving the invoices on timely manner. Responding to the Internal and External queries on Payment and invoice related queries. Assist with the supporting documents as and when requested by Auditors. Complexity Ability to perform a range of work activities in varied environments. May contribute to routine issue resolutions. Autonomy Working under routine direction. Uses limited discretion in resolving issues or enquiries work without frequent reference to others. Environment Understand the business drivers. Other Carryout any other reasonable duties as requested. Functional Competencies (Technical knowledge/Skills) Preparing the daily invoices on ERP system and providing them for approver to review. Ensure all the invoices are processed with right coding details. Reaching out to internal stake holders on the invoice related queries. Working closely with Procurement team on the PO related issues. Applying the 3-way matching concept to make sure the invoices are accurate and as per the agreed terms. Performing vendor reconciliation and identifying any discrepancies and communicating with vendor. Ensure the payments are properly applied by the vendor as per the remittance advices generated out of the payment run. Extend support during the close to ensure all the invoices are processed before close. Support during the audit with requested documents and other reports. Experience, Education, and Certifications 1+ years of relevant experience in invoice processing. Exemplifies traits of being a team player With continuous improvement and critical mindset With solid communication skills verbal and nonverbal. Preferably with a bachelor s degree in finance/accounting as Major Subject. English: Fluent Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Job Summary: The Senior Solution Architect is responsible for defining end to end solutions and / or business offerings to meet the functional and non-functional requirements of the end customer while ensuring it is costed, delivered to specification and can be operated. It is the Solution Architects role to ensure that all elements of the solution are delivered including the business, application, technology layers while complying to information and security requirements and provision an operational service by directing the domain and functional experts within each of these domains. We are seeking a highly skilled and experienced Senior Solutions Architect to join our team. The ideal candidate will be an expert in building modern PaaS and SaaS platforms, following agile architecture and leveraging cloud-native technologies, particularly Azure. They will have a strong background in the life sciences and clinical trials segment and a proven track record of leading change and adopting new technologies, such as AI, to deliver high-quality designs to engineering teams. Key Responsibilities: Lead the development of end-to-end solutions that meet functional and non-functional requirements. Ensure the delivery of business, application, and technology layers while complying with information and security requirements. Provide technical leadership and guidance to architects, engineering teams, and other related functions. Drive the adoption of agile methodologies and cloud-native technologies, particularly Azure. Lead the implementation of new technologies, such as AI, to accelerate solution delivery. Collaborate with stakeholders to define and prioritize requirements and manage competing priorities. Conduct risk assessments and develop countermeasures and contingency plans. Monitor emerging technologies and evaluate their potential impact on our solutions. Qualifications: Bachelors Degree in a technical discipline (Maths, Science, Engineering, Computing, etc.) or equivalent project-related experience. Demonstrable experience in technical delivering utilising modern SaaS Platforms with a proven record in design and architecture activities. Certification in agile delivery (e.g., SAFe, Scrum) and design methodologies (e.g. TOGAF, UML). Expertise in cloud-native technologies, particularly Azure, including Service Bus, PaaS DBs, Azure Functions and Containers. Experience with medical imaging and DICOM. Knowledge of the life sciences and clinical trials segment is highly desirable, as is any experience in AI-driven image analysis and machine learning algorithms for medical imaging. Excellent interpersonal, verbal, and written communication skills. Ability to manage multiple tasks with enthusiasm and prioritize workload with attention to detail. Strong initiative, self-confidence, and adaptability to cope with changing priorities. Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Key Responsibilities Information Security Operations Incident Response Monitor information security alerts and logs using XDR and other security tools. Investigate potential information security incidents, escalate critical issues, and support information security incident response processes. Endpoint, Cloud, and Network Security Assist in managing security controls for endpoints, cloud services, and network environments. Support security hardening initiatives to reduce risks. Email Security Gateway Anti-Phishing Manage and optimize email security solutions to prevent phishing, malware, and spam attacks. Work on email filtering policies, domain security (DMARC, DKIM, SPF), and respond to email-based threats. Vulnerability Patch Management Perform routine security assessments to identify vulnerabilities and misconfigurations. Work with IT teams to prioritize and implement security patches and updates. Threat Intelligence Risk Mitigation Analyze emerging threats and recommend proactive security measures. Assist in conducting risk assessments and security reviews of new technologies and processes. Compliance Security Governance Assist in maintaining security policies and ensuring compliance with contractual regulatory requirements (ISO 27001, GDPR, HIPAA, etc.). Support audits and security assessments. Security Awareness Training Promote cybersecurity awareness by assisting with security training sessions and phishing simulations. Support internal teams with security best practices. Functional Competencies (Technical knowledge/Skills) Strong understanding of cybersecurity frameworks (ISO 27001, NIST, CIS Controls). Experience with XDR, firewalls, endpoint security, and cloud security solutions. Familiarity with Email Security Gateways (Proofpoint, Mimecast, etc.) and anti-phishing technologies. Basic knowledge of penetration testing and vulnerability scanning tools. Hands-on experience with IAM and access control mechanisms. Understanding of regulatory and compliance requirements in cybersecurity. Strong analytical skills with attention to detail. Good communication and collaboration skills to work across teams. Behaviour Competencies Mandatory Success Factors: Accountability Adaptability Customer Focus Optional Success Factors: Willingness to Learn Time Management Analytical Thinking Results Orientation Experience, Education, and Certifications 5+ years of experience in cybersecurity operations or security administration. Bachelor s degree in Cybersecurity, Information Technology, or a related field. Certifications such as CompTIA Security+, CEH, or equivalent preferred. Experience working with email security solutions and incident response processes. Knowledge of cloud security in AWS, Azure, or GCP is an advantage. Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Job Purpose: As Principal Software Quality and Test, you will be responsible for efficiently leading a team of testers to meet the team s testing goals. In this role, you will also be responsible for identifying tests suitable to be automated, defining the approach, and either creating reusable modules and scripts, or overseeing others to create. To fulfil this role, you must understand the project technically functionally and implement the test approach defined in the test plan documents. You must also understand the functional and technical aspects of the work and implement the test approach defined with an understanding of how it changes throughout the software development lifecycle (SDLC). In this role , you may be required to support customer validation activities to support the successful validation of our products and services within customer organisations, by leading a team and/or providing expert advice to stakeholders. Another key aspect of the role is the contribution to the continuous improvement of the capability within the organisation to facilitate first-time-quality, and as such the role must be oriented towards teamwork in an emerging and flexible environment. Skills: Excellent interpersonal, verbal and written communication skills A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to effectively delegate work to team members Must have the ability to work methodically in a fast-paced, time-sensitive environment Demonstratable ability to apply critical thinking to problems and tasks Builds and maintains an in-depth knowledge of testing and validation within the life sciences industry and how they affect customers adopting our products Ability to identify and plan testing activities to meet testing / validation goals Ability to identify tests suitable for automation Ability to create automated test scripts that meet the testing objectives or can instruct others to implement the automation approach Proactively participates in skills improvement training Ability to coach and mentor colleagues in the test team Maintains an up-to-date awareness of trends, tools, technology, techniques and processes that affect testing and technology within the Life sciences domain A self-starter and able to work under own initiative Knowledge and Experience: Experience on Medical Imaging domain Ability to develop test automation frameworks using Selenium, Playwright and Tosca Hands-on experience in scripting languages like C#, Java Script, Java Ability to perform automation code reviews Must have knowledge on latest Software Testing trends and implement in MI testing by adopting shift left approaches Must have Performance testing and Security testing knowledge Proven experience leading or mentoring colleagues in a software testing / validation team Experience using tools to communicate progress to Stakeholders Experience of coaching and mentoring a range of junior colleagues and cross functional peers ISTQB Foundation or equivalent Extensive experience in the same or very similar role Experience of working in and knowledge of the life sciences sector Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Job Summary: A Senior Medical Writer will create, research, edit and coordinate the production of clinical documents related to independent review, including independent review charters, clinical data forms, manual case report forms, applicable reviewer training materials, project deviations and supplementary imaging reports, either independently or using available central content and templates. The medical writer will serve as a contact with clients. Key Accountabilities: Information Content authoring Gather, review, analyze, and evaluate relevant resources to prepare, develop, and finalize applicable clinical documents for submission to regulatory authorities. Prepare, develop, and finalize applicable clinical documents not intended for submission to regulatory authorities. Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable. Perform literature searches/reviews as necessary to obtain background information and training for development of documents. Draft and/or ghost-write clinical documents for more experienced medical writers Act as support to others in the team to ensure that all documentation is accurate and encompasses all relevant information based on Stakeholder needs. Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, central content, and general guidelines for clinical documentation and workflow procedures. Initiate and participate in marketing initiatives, such as white paper, abstract, poster, and manuscript development Document Project Management Serve as primary client contact for medical writing projects, negotiating deliverable timelines, and resolving project-related issues. Serve as the medical writing representative on assigned project teams communicate content requirements, lead/facilitate authoring team meetings to agree on expectations Coordinate and conduct interdepartmental team reviews of draft and final documents, Evaluate progress on tasks, identify issues and facilitate resolutions, and advance document development to approval, according to Perceptive and/or client guidelines/SOPs. Distribute final documents to project team and client in a timely manner and to agreed timescales Identify potential project challenges and raise with all relevant stakeholders, including changes in timelines or out of scope requests, and suggest possible resolution options. Attend project team meetings as required. Ensure appropriate filing of applicable project documentation May provide project management of contractual and financial aspects. Relationship management Implements stakeholder engagement/communications plan. Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information. Collects and uses feedback from customers and stakeholders to help measure effectiveness of stakeholder management. Helps develop and enhance customer and stakeholder relationships. Quality management Uses appropriate methods and a systematic approach in the development, maintenance, control and distribution documents. Prepares documents for publishing readiness, ensuring document consistency and integrity Ensures documentation adheres to FDA/EMA or other appropriate regulatory guidelines, and / or relevant SOPs. Provides medical editing review of draft and final documents prepared by other medical writers before internal or external distribution. This includes both copyediting and content review. Follows required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable. Makes changes to and controls the updates and distribution of quality standards. Relationship management Implements stakeholder engagement/communications plan. Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information. Collects and uses feedback from customers and stakeholders to help measure effectiveness of stakeholder management. Helps develop and enhance customer and stakeholder relationships. Other Carryout any other reasonable duties as requested. Skills: Excellent interpersonal, verbal, presentational and written communication skills Ability to consistently produce documents of high quality A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Must have the ability to work methodically in a fast-paced, time-sensitive environment Demonstratable ability to apply critical thinking to problems and tasks Shows initiative and self-confidence, is adaptable and is able to cope with changing and evolving priorities Ability to identify and implement process improvements Proactively participates in skills improvement training and encourages their teams to participate Ability to negotiate on behalf of medical writing to ensure resources, timelines, and expectations are aligned Maintains an up-to-date awareness of trends, tools, technology, techniques, processes and documentation requirements that affect technology within the Life sciences domain A self-starter and able to work under own initiative Proven ability of using Microsoft Office products (including Word, Excel PowerPoint) Knowledge and Experience: Experience using tools to communicate progress to Stakeholders Experience of regulated environments Understanding of Agile methodologies Experience of working in and knowledge of the life sciences sector Solid knowledge of industry guidelines and regulations, i.e., ICH-GCP. Experience of regulatory documents in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications. Solid Professional experience in the same or very similar role Experience using data analysis tools (e.g. Tableau, Power BI) desirable Proven ability of using Microsoft Office products (including Word, Excel PowerPoint) Education: Bachelors Degree in a technical discipline (Science, pharmacy, nursing, or other health-related discipline preferred etc.) or a related study, or equivalent project-related experience English: Fluent (written and verbal) Non-English language (Written and verbal) desirable Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Key Accountabilities: Methods and tools Provides advice / guidance / expertise to support adoption of methods and tools and adherence to policies and standards, process tailoring in line with agreed standards and evaluation of methods and tools. Reviews and improves usage and application of methods and tools. Emerging technology monitoring Supports market monitoring and assessment of emerging technologies to evaluate potential impacts, threats and opportunities. Contributes to reports and technology road mapping and sharing knowledge and insights with of emerging technologies with others. Requirement definition and Management Contributes to selection of the requirements approach for projects, selecting appropriately from plan-driven/predictive approaches or more adaptive (iterative and agile) approaches. Defines and manages scoping, requirements definition and prioritisation activities for initiatives of medium size and complexity. Facilitates input from stakeholders, provides constructive challenge and enables effective prioritisation of requirements. Reviews requirements for errors and omissions. Establishes the requirements baseline, obtains formal agreement to requirements, and ensures traceability to source. Investigates and processes and applies requests for changes to base-lined requirements. System Design Designs components using appropriate modelling techniques following agreed architectures, design standards, patterns and methodology. Identifies and evaluates alternative design options and trade-offs. Creates multiple design views, allows to address the concerns of the different stakeholders of the architecture and to handle both functional and non-functional requirements. Models, simulates or prototypes the behaviour of proposed systems components to enable approval by stakeholders. Produces detailed design specification to form the basis for construction of systems. Reviews, verifies and improves own designs against specifications. Software Design Selects, adopts and adapts appropriate software design methods, tools and techniques; selecting appropriately from predictive (plan-driven) approaches or adaptive (iterative/agile) approaches. Specifies and designs large or complex software components. Undertakes impact analysis on major design options, makes recommendations and assesses and manages associated risks. Specifies prototypes/simulations to enable informed decision making. Evaluates the quality of others systems designs to ensure adherence to standards and identifies corrective action, if needed. Ensures that the system design balances functional, quality, security and systems management requirements. Contributes to development of organisational software design and architecture policies and standards. Change Management Assesses, analyses, develops, documents and implements changes based on requests for change. Solution Architecture Contributes to the development of solution architectures in specific business, infrastructure or functional areas. Identifies and evaluates alternative architectures and the trade-offs in cost, performance and scalability. Produces specifications of cloud-based or on-premises components, tiers and interfaces, for translation into detailed designs using selected services and products. Supports a change programme or project through the preparation of technical plans and application of design principles that comply with enterprise and solution architecture standards (including security). Quality Management Uses appropriate methods and a systematic approach in the development, maintenance, control and distribution of quality and environmental standards. Makes technical changes to and controls the updates and distribution of quality standards. Distributes new and revised standards. Business Risk Management Investigates and reports on hazards and potential risk events within a specific function or business area. Other Carries out any other reasonable duties as requested. Skills: Excellent interpersonal, verbal and written communication skills A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Shows initiative and self-confidence is adaptable and is able to cope with changing and evolving priorities Must have the ability to work methodically in a fast-paced, time-sensitive environment Ability to apply domain knowledge to align and advise the best approaches and tools to meet business requirements Ability to clearly convey requirements within application domain to key stakeholders and provide solution components that realise the requirement of domain design Ability to clearly advise on areas of solution that may cause issues within application domain that may create issues and challenge the need of given requirements based on economic, time, business and complexity factors Ability to manage provision of consultancy services. In own areas of expertise, able to provide advice and guidance to consultants and/or the customer or other stakeholders through involvement in the delivery of consultancy services Knowledge and Experience: Demonstrable experience in technical delivery with a proven record in undertaking design and architecture activities Experience of Application architecture for building application products and components. Design methodology experience. Certification (e.g. UML) desirable Experience in scaled agile delivery. Certification (e.g. SAFe) desirable Experience in agile delivery. Certification (e.g. scrum) desirable Education: Bachelors Degree in a technical discipline (Maths, Science, Engineering, Computing, etc.) or a related study, or equivalent project-related experience English: Fluent Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Skills: 4+ years of working experience as Product Owner; Agile experience and Medical Imaging Experience Job Summary: As a Senior Product Owner, your role sits within the Product Group and is responsible for facilitating the generation and maximization of value from our products and services for our customers, both internal and external. You will take accountability for the delivery of large initiatives (projects / epics / capabilities). Your role involves translating the product roadmap into a delivery roadmap, ownership of the Team Backlog (user stories) delivering the features (via user Stories) for your assigned product, solution or epic, prioritizing the work, working closely and directly with agile delivery teams, participating in SAFe and scrum ceremonies, functionally guiding other Product Owners to completion and overseeing the end to end delivery process to execute the product requirements. Key Responsibilities Product Backlog Management Requirements: Takes ownership of team backlog (user stories) and breaks down features into user stories for one or more products/ applications. Takes ownership for work on large initiatives (epics/capabilities) and assists with more complex change initiatives. Elicits, identifies, documents, and refines requirements from business problems detailed in features into user stories and acceptance criteria that may include technical requirements. Ensures Non-Functional requirements are captured and recorded in the acceptance criteria in user stories. Prioritizes the user stories in the product backlog (with business stakeholders and Product Manager), to ensure the items with the highest business value are at the top of the backlog and being worked on by the delivery team. Ensures the product backlog is clearly communicated to business stakeholders and reflects their requirements. Supports Product Managers on the refinement of features. Product Delivery: Leads and influences one or more cross-functional agile delivery teams to execute, and delivers on, product requirements. Works closely with the delivery team on a day-to-day basis, to action features/user stories. Participates and plays a lead role in SAFe ceremonies, scrum meetings, sprint demos, retros and product sprints with the delivery team. Represents the voice of the customer at the delivery team level by ensuring the product backlog items are visible and clear. Maintains metrics on the progress of the Team backlog and team deliverables. Monitors the quality of the deliverables by managing defects. Defines and refines the delivery roadmap and drives what goes into each release. Provides updates on project outcomes to clients or customers. Plays an active role in release activities, ensuring the relevant documentation is in place. Identifies, records and mitigates operational and technical risks on own initiative. Follows agreed standards and ensures all relevant documentation is maintained in accordance with relevant regulatory guidelines and SOP s ensuring all relevant stakeholders are updated. Follows and is a leading advocate of the standard Product Owner practices and processes, ensures adherence and support in the definition of these standards. Owns the delivery of the Functional Requirements Specification (FRS). Functional Leadership: Provides coaching and support to the Product Owners in the group to help them develop and refine skills. Guides and leads, from a functional basis, one or more Product Owners on specific projects by distributing work and supporting them during the end-to-end process. Leads by example and provides clear direction and guidance to other Product Owners and is accountable for performance. Relationship management: Engages and influences wide variety and level of stakeholders including senior management, making recommendations on initiatives. Engages with stakeholders and end-users to gather feedback, understands their needs, and relays this information to the delivery team. Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information. Manages expectations of stakeholders on what is being delivered / released and what is not being delivered. Helps develop and enhance stakeholder relationships. Business analysis: Leads investigating operational requirements, problems, and opportunities, seeking effective business solutions through improvements in automated and non-automated components of new or changed processes. Leads the analysis of stakeholder objectives, and the underlying issues arising from investigations into business requirements and problems and assists in identifying options for consideration during the delivery process. Works iteratively with stakeholders, to identify potential benefits and available options for consideration, and in defining acceptance measures. User centricity analysis: Works closely with UX Design to ensure mock-ups are ready on time and accurately reflect expected product design. Evaluates prototypes or designs of systems, products or services against agreed usability and accessibility expectations. Interprets and presents results of evaluations and priorities issues. Works with Product Managers to detail user journeys (AS IS and TO BE) and user activities to better determine baseline metrics and identify where improvements/efficiencies can be made. Business process improvement Analyses and designs business processes, identifies alternative solutions to exploit new technologies and automation. Develops graphical representations of business processes to facilitate understanding and decision making. Analyses and designs the assessment for feasibility of business process changes and recommends new approaches. Implements business process improvement methods and tools at program, project and team level in line with agreed standards. Data Analysis (if required): Leverages data analysis to extract meaningful insights, enabling informed and data-driven decision-making. Develops models and diagrams to represent and communicate data requirements and data assets. Other: Carryout any other reasonable duties as requested. Functional Competencies (Technical knowledge/Skills): A strong understanding of SDLC and related technologies is necessary. Detailed knowledge of medical imaging domain area including modalities, equipment, Imaging endpoints, read criteria and viewers in the relevant Service Lines. Understanding of Agile methodologies (preferably Scrum and SAFe, UML, and orientated, Data Modelling using appropriate industry standards and/or other BA methodologies). Demonstrable knowledge of Lean Six Sigma. Demonstrable knowledge of Root Cause Analysis. Demonstrable knowledge of risk identification, analysis and mitigation. Excellent interpersonal, verbal and written communication skills. A flexible attitude concerning work assignments and new learning. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. Ability to work methodically in a fast-paced, time-sensitive environment. Displays a product mindset with strategic and user-centric thinking. Demonstrable ability to apply critical thinking to solve problems and tasks. Shows initiative and self-confidence, is adaptable and can cope with changing and evolving priorities. Ability to identify and implement process improvements. Proactively participates in skills improvement training and encourages their teams to participate. A self-starter and able to work under own initiative with ability to define owns path and drives work forward with little guidance or supervision. Adapts to new environments with little guidance. Good confident presenter to peers and stakeholders, including senior management. Maintains an up-to-date awareness of trends, tools, technology, techniques, and processes that affect technology within the Life sciences domain. Natural coach who leads by example with an approachable demeanor. Experience, Education, and Certifications: Solid professional experience as a Product Owner or in a very similar role. Experience in coaching and training colleagues and peers. Experience of working in and knowledge of medical imaging in clinical trials within the life sciences sector Demonstrable experience of regulated environments. Experience with product lifecycle management tools. Experience in process Modelling using standards such as BPMN. Experience in Scope Management. Bachelors Degree in a technical discipline (Maths, Science, Engineering, Computing, etc.) or a related study, or equivalent project-related experience. English: Fluent. Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs trainings Job Summary: As Senior Cloud Engineer, you will build solutions to enhance availability, performance, and stability of our cloud services, along with the enabling platform automation and technical services for solution delivery in line with regulatory compliance. You will be working primarily on non-production environments and supporting the release of products into production environments. You will be responsible for data collection and configuration management, as well as disaster recovery planning, capacity engineering, reliability improvement initiatives and platform automation. This may require you to work outside of normal business hours providing support to the development and support functions. In this role you will be responsible for understanding and setting the example of best practice and standards to develop and implement solutions that operate at scale - seeing your own technology efforts directly improve the reliability and availability of products and achieve the aspiration of Release on Demand . You will own development efforts in each sprint from planning to delivery to realise this goal and collaborate with different teams to review, design and implement solutions. As Senior Cloud Engineer, you will be expected to take on more complex activities either as part of a team or independently and when in a team you will be expected to promote the behaviours and standards that others aspire to achieve. Key Accountabilities: Release deployment Assesses and analyses release components. Provides input to scheduling. Carries out the builds and tests in coordination with testers and component specialists maintaining and administering the tools and methods - manual or automatic - and ensuring, where possible, information exchange with configuration management. Ensures release processes and procedures are maintained. Service acceptance Engages with project management to confirm that products developed meet the service acceptance criteria and are to the required standard. Feeds into change management processes. System software Reviews system software updates and identifies those that merit action. Tailors system software to maximise hardware functionality. Installs and tests new versions of system software. Investigates and coordinates the resolution of potential and actual service problems. Prepares and maintains operational documentation for system software. Advises on the correct and effective use of system software. Programming software development Designs, codes, tests, corrects and documents complex programs and scripts and integration software services and subsequent iterations. Applies agreed standards and tools, to achieve well-engineered outcomes. Participates in reviews of own work and leads reviews of colleagues work. Systems integration build Defines the software modules needed for an integration build and produces a build definition for each generation of the software. Accepts completed software modules, ensuring that they meet defined criteria. Produces software builds from software source code for loading onto target hardware. Configures the hardware and software environment as required by the system being integrated. Produces integration test specifications, conducts tests and records and reports on outcomes. Diagnoses faults and records and reports on the results of tests. Produces system integration reports. Systems design Undertakes complete design of simple applications using simple templates and tools. Assists as part of a team on design of components of larger systems. Produces detailed designs including for example: physical data flows, file layouts, common routines and utilities, program specifications or prototypes, and backup, recovery and restart procedures. Methods and tools Provides advice and guidance to support adoption of methods and tools and adherence to policies and standards. Tailors processes in line with agreed standards and evaluation of methods and tools. Reviews and improves usage and application of methods and tools. Conformance review Conducts formal reviews of activities, processes, products or services. Collects, collates and examines records as part of specified testing strategies for evidence of compliance with management directives, or the identification of abnormal occurrences. Analyses evidence collated and drafts part or all of formal reports commenting on the conformance found to exist in the reviewed part of an information systems environment. Emerging technology monitoring Supports monitoring of the external environment and assessment of emerging technologies to evaluate the potential impacts and opportunities to the organization for new ways of working. Contributes to the creation of briefings and presentations, technology road mapping and the sharing of knowledge and insights about the relevance and potential value of new technologies to the organization. Specialist advice Actively maintains knowledge in one or more identifiable specialisms. Provides detailed and specific advice regarding the application of their specialism(s) (i.e. in an aspect of information or communication technology, technique, method, product or application area). Capacity management Monitors service component capacity and initiates actions to resolve any shortfalls according to agreed procedures. Applies techniques to control the demand upon a particular resource or service. Contributes to capacity modelling and planning. Supports the design of service component capacity. Incident management Prioritises and diagnoses incidents according to agreed procedures. Investigates causes of incidents and seeks resolution. Escalates unresolved incidents. Facilitates recovery, following resolution of incidents. Documents and closes resolved incidents according to agreed procedures. Other Carryout any other reasonable duties as requested. S kills: Excellent interpersonal, verbal and written communication skills and positive stakeholder management Demonstrates ability to present to small-medium sized audiences A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, including management of documentation Takes ownership and responsibility; shows initiative and self-confidence, is adaptable and is able to cope with changing and evolving priorities Must have the ability to work methodically in a fast-paced, time-sensitive environment Demonstrates problem solving and critical thinking skills and ability to work under pressure Willingness to work in a matrix environment and to value the importance of teamwork Awareness of the value and perception of your activities on your peers and wider team Ability to operate collaboratively within a global team environment A self-starter and able to work under own initiative Maintains an in-depth knowledge of specific specialism in the field and provides expert advice regarding the application showing leadership when researching and implementing new solutions Natural coach/mentor who leads by example with an approachable demeanor Knowledge and Experience: Azure PaaS IaaS VM setup, configuration, engineering development experience Experience in Microsoft Office 365 and PowerApps engineering desirable Understanding of CI/CD pipeline build, improvement, and management Hands on demonstrable experience with cloud infrastructure: Azure PaaS IaaS, PowerShell ARM Template Automation, Software Defined Networking, Virtual machine automation for Windows Server, Linux and associated infrastructure management layer automation Exposure to and maintenance of configuration management and orchestration tools Diagnosing and troubleshooting incidents, problems and service-outages in web applications and network services Exposure to system and application-level telemetry for large distributed micro services Cloud Architectures Understanding in building cloud services within regulated environments Azure Devops, Octopus Deploy, TeamCity, Jenkins, SonarQube, Git experience or knowledge of similar products also be useful Experience of robust and repeatable automation of third-party products into Azure IaaS (e.g., Oracle, Java, Tenable, etc.) Excellent knowledge of ITIL, Foundation certification is desirable Experience in Scrum Agile methodologies Microsoft Azure Certifications are desirable Education: Bachelor s Degree in a technical discipline (Software Engineering, Computer Science etc.) or a related study, or equivalent related experience English: Fluent Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Updating financial systems with contractual arrangements with clients, staff deployment on projects (staff plans) and deliverables achieved. Preparation of the monthly revenue report comparing actual revenue versus forecast with supporting explanations and calculations for variances. Performing reconciliations of contracts and revenues recognised. Liaising with the billing team regarding unbilled revenue balances. Assisting with monthly reports (forecast, backlog, utilisation). Ensure revenue is recognised within SOX guidelines i.e. relevant controls, documentation, signoffs, and filing are in place. Role Requirements Business/Finance degree or Part Qualified (ACCA, CIMA etc) or both Minimum of 3 years experience in a Finance role Oracle Financials experience preferable Good knowledge/experience with MS Excel Good communication and interpersonal skills Ability to work to tight deadlines with an absolute commitment to accuracy Demonstrate an ability to manage own work in an efficient manner and to work with a high degree of own initiative

Team Leadership & Oversight Support and mentor a team of Clinical Data Specialists, promoting consistency, quality, and productivity. Collaborate on training plans, performance goals, and team development. Provide day-to-day guidance and technical support related to data issues. Help manage team capacity, workload distribution, and scheduling across studies. Foster effective collaboration with cross-functional teams. Data Management & Quality Assurance Accurate data maintenance, quality control, and discrepancy resolution in CTMS and EDC systems (e.g., RAVE, Veeva Vault, Clinical One, Inform). Review source documents for adherence to ALCOA-C principles and regulatory guidelines (GCP, HIPAA, FDA). Identify and resolve data inconsistencies and protocol deviations. Collaborate with clinical operations to ensure accuracy and completeness of source documentation. Support audit readiness through rigorous documentation practices and participation in quality reviews. Assist in creating source documents from protocols, CRFs, and lab manuals. Drive timely completion of data cleaning and database lock activities. Track and report key metrics for data quality and operational efficiency. Process Development & Compliance Develop SOPs, training guides, and implement process improvements. Identify inefficiencies and propose solutions to enhance workflow and team productivity. Participate in audits and collaborate on regulatory responses. Promote adherence to industry and internal standards. Cross-Functional Collaboration Serve as the point of contact for clinical data inquiries across assigned studies. Coordinate timelines and deliverables with project managers, monitors, and external stakeholders. Support all phases of the clinical study lifecycle from initiation to close-out. Qualifications and Experience Bachelor's degree in life sciences, health sciences, nursing, or a related field. Minimum 12 years of relevant experience, with at least 7 years in a Clinical Research Coordinator or Clinical Data Management role. Prior Managerial experience is a plus; must exhibit ability and willingness to take on supervisory responsibilities. Strong knowledge of CTMS (e.g., CRIO) and EDC systems such as RAVE, Veeva Vault, Clinical One, and Inform. Solid understanding of GCP, HIPAA, ALCOA-C, and clinical trial protocol standards. Must demonstrate ability to read, interpret, and operationalize clinical protocols. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). Ability to work independently while building processes and guiding others. Willingness to align with US operating hours.

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Premier Research is looking for a Associate Data Manager - FS to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. What we are searching for: Assists in preparing clean databases by performing a review of clinical trial data through the CDMS or external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan Provide input to and review of Data Management Plans in support of clinical study deliverables Generates queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates, and client representatives) to resolve problematic data identified during every aspect of the data management process Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies the database accordingly Supports the development of CRFs and edit check specifications per protocol and participates in user acceptance testing of CRFs and associated edit check specifications as required Assists in the user acceptance testing for study-specific data listings ensuring data output adheres with requirements Prepares and maintains documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required What we are searching for: Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience 3 to 5 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions. Demonstrates excellent English verbal and written communication skills Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc) Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities

Assists with the design/development of software solutions requiring general domain knowledge and limited business expertise. Troubleshoots code issues and continuously evolves IQVIAs platforms to meet user requirements/needs. Essential Functions Assists with the design/development of software solutions requiring general domain knowledge and limited business expertise. Works at all layers of the application stack including front-end user interface and backend development. Troubleshoots code issues and continuously evolves IQVIAs platforms to meet user requirements/needs. Reviews functional specifications and other validation deliverables as assigned. Develops a basic understanding of industry and IQVIA-specific quality standards. Supports development projects based on specific instructions and with limited discretion. Typically requires 1 year of prior relevant experience. Qualifications Bachelors Degree Computer Science, a related field, or equivalent experience Req

Finance Analyst Location: Bangalore The Finance Analyst will be responsible for supporting the RWS Global Database delivery team in all areas of revenue recognition, invoicing and project margin. They will be required to coordinate regular meetings with various stakeholders as well as managing the preparation of internal financial reports including analysis to show variances between actuals and forecasts. Principal Responsibilities: Manage timely revenue recognition by working with various project managers to obtain labor forecasts and project statuses. Communicates changes in revenue and project margins to various stakeholders. Provides financial reporting to the RWS Global Finance teams team. Develops a strong understanding of internal and external revenue recognition rules to ensure revenue against customer contracts is in compliance with US GAAP and internal guidelines. Builds strong relationships with the project management, offering and finance teams to ensure queries are efficiently addressed meaning no delay to business operations. Challenges the current ways of working and provides alternative solutions to improve quality and efficiency of processes. Minimum Education, Experience, & Specialized Knowledge Required: 2+ years experience Bachelor s degree or equivalent in analytical subject and experience in an analytical role. Must be IT literate, with experience of financial reporting or accounting packages (SAP is preferred), Excel, Word and PowerPoint. A good working knowledge of any other European languages would be a plus. Additional Requirements: Strong interpersonal skills. Works well under pressure. Highly analytical with an ability to design, plan and implement process improvements. Ability to carry out detailed analysis and information gathering to resolve problems on non-routine matters. Ability to work independently with minimal supervision. Must be flexible and an effective team player with the ability to multi-task.