260 Clinical Development Jobs - Page 10

ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, Job Title: Manager, TMF Operation Location : Bangalore What You Will Be Doing Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs, To manage document management departmental activities for internal services or client services in accordance with client and study requirements, ICON SOPs/WPs and regulations, where applicable To inform department management of training issues, project activities, quality issues and timelines as directed, To ensure activity/status tracking is completed in accordance with department/client requirements Tracking includes: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving, To ensure appropriate maintenance of document files and storage areas in accordance with ICON and/or client requirements and SOPs/WPS and applicable regulations as directed by the department head You Are Bachelors degree in life sciences, clinical research, or a related field Extensive experience in TMF management or clinical operations within the pharmaceutical or clinical research industry, Strong understanding of GCP, ICH guidelines, and global regulatory requirements related to TMF management and clinical trial documentation, Proven leadership skills, with experience managing and developing teams in a fast-paced, regulated environment, What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc,com/benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, https://careers iconplc , com / reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

Title Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Medical Writer to join our Core Labs in Mumbai office. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities •Generate, revise, and maintain clinical documents; •Coordinate quality control of documents and maintain audit trail of reviews and changes; •Provide input on data analysis planning and its impact on clinical document outcome ; and •Performs other duties and responsibilities as assigned. Qualifications Master’s degree in a health or science-related field; Possess strong communication skills (oral and written); Intermediate knowledge of medical terminology and clinical patient management; People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets

Candidate should have very good knowledge and working experience on MS Word, MS Excel, MS PowerPoint and E-Tabs Automation Software. He/ She should have a good communication skill. Should be a good team player and flexible to work in different shifts based on our project requirements. Essential Duties and Responsibilities: Very good knowledge and experience in working in MS PowerPoint and MS Excel Should have a good oral and written communication skill Flexible in time PRE-REQUISITES FOR THE ROLE: Charting experience in PowerPoint E-Tabs Automation Tool Healthcare industry knowledge will be added advantage Communication skill OTHER REQUIREMENTS: Market research background Education and Training Required: Graduate and should be very good with MS Office tools and E-tabs Knowledge, Skill, Ability: Should have good communication skill and should be a good team player Qualifications Graduate or Degree in relevant field

Job Description: SENIOR SAS PROGRAMMER The Senior SAS programmer leads the programming activities for various purposes including CSRs, DSMBs, interim analyses, manuscripts, etc. Mainly supports statistical programming of statistical analysis plan (SAP)-planned tables, data listings, and graphs for CSRs, as well as integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents, and patient profiles. In addition, the Senior SAS Programmer supports migration activities in the creation of Standard Data Tabulation Model (SDTM) and production of the Analysis Data Model (ADaM). The Senior SAS Programmer is also responsible for monitoring and meeting assigned program milestones and will lead a team of programmers to accomplish tasks. VERISTAT INFO For more than 30 years, Veristat has built a reputation as global experts in clinical development, registration, and post-marketing solutions. We have done so by hiring talented people whose core values are aligned with ours and who share a common passion for our mission driven work. We do things differently than other CROs and would love to have you join our Veristat team! Experience & Minimum Requirements Bachelor s Degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 8 years of SAS programming experience with clinical trial data OR Master s Degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 6 years of SAS programming experience with clinical trial data. Good working knowledge of CDISC SDTM and ADaM Implementation Guidelines. General knowledge of regulatory requirements and drug development process. Excellent organizational skills and good verbal and written communication skills. Ability to work independently as well as lead programming teams. Strong communication skill set with peers, business partners, and Sponsors. Strong Analytical mindset. Leadership skills to lead project team to deliver high quality deliverables on time and work directly with the Sponsor to meet the project delivery expectations. Must be fluent in English (written and verbal).

Purpose: Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly . To work with cross-functional, multidisciplinary teams to prepare scientific publications (clinical and/or health-outcomes) including and not limited to, abstracts, posters, manuscripts and presentations. Primary Responsibilities : This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with the hiring team. 1.Content Strategy : Document Preparation, Development and Finalization/Document Management Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects. Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review coordinate and complete the publication of scientific data in peer-reviewed journals and forums Conduct effective document initiation via a kick-off meeting to ensure authoring team alignment and understanding. Build scientific-based rational that support the purpose of more complex and/or strategic documents. Ensure data are presented in a clear, complete, accurate, and concise manner. Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data. Coordinate expert/scientific reviews, collate reviewer s comments, adjust content of document as required based on internal/external input, and prepare final version. Ensure and coordinate quality checks for accuracy, Exhibit flexibility in moving across development and preparation of multiple document types. Influence or negotiate change of timelines and content with other team members. Advocate internally and externally for appropriate authorship criteria on all applicable work products. Work with internal and external speakers to develop and prepare presentations. As needed, build and manage relationships with vendors/alliance partners. 2.Project and Stakeholder management Lead the writing process and apply effective project management skills to ensure timely completion of high-quality scientific publication deliverables. Build/Communicate credible writing project timelines. Anticipate and mitigate risks to delivery Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion. Effectively communicate project status to stakeholders. 3. Knowledge and Skills Development Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s). Maintain and enhance scientific communication skills to align with audience needs and technology/digital evolution. Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment. Maintain and enhance knowledge of publication guidelines. Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in publication planning, integrated planning process, and/or current awareness literature updates and reviews. 4.Knowledge Sharing Provide coaching to others by sharing technical information, giving guidance, answering questions. Recognized for technical expertise in specific document development. Network with others (including other functions and regions) to identify and share best practices. Contribute to process improvements, suggesting opportunities where appropriate. Provide database and other tool (e.g., document management systems) expertise. Minimum Qualification Requirements: Master s degree in a scientific field Experience writing scientific publications. Strong communication and interpersonal skills. Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process) Other Information/Additional Preferences: Advanced degree (PhD, MD, PharmD, MA, MBBS) in science, health related field or other appropriate disciplines (economics, epidemiology, health administration, health services, Pharmacoeconomics, statistics other relevant sciences) Desired: H ealth, communications, health outcomes, health economics, public health related expertise Demonstrated mastery of verbal and written English skills in the medical, scientific, health outcomes, or technical writing fields. Previous training and experience in disseminating results in clinical, health economics, health outcomes, health literacy, disease management, and/or population health. Relevant experience in clinical development, clinical trial process, health-outcomes research, or regulatory activities. Clinical pharmacology, therapeutic area, health outcomes, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise). Demonstrated project management and time management skills. Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates). Extensive experience in writing, reviewing, and publishing scientific materials and the ability to appraise scientific literature and raw data critically. Ability to communicate clearly and succinctly with all audiences and forums through exemplary oral and written communication skills. . .

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work Job Description: Act as SME for safety business and track industry trends relevant to safety Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions Responsible for improving capability presentations and Identifying service areas and solutions and work with the operational leadership to build capabilities Participates in the analysis and definition of efficient, cost effective and creative solutions deliver competitive value propositions to the industry Build partnership with senior leadership across the industry in Safety and PV Represent the company in trade conferences, speaker sessions etc. Identify and build potentially synergistic partnerships to expand client and service footprints Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed Must Have - MBBS/ MD with a minimum of 8-10 years of experience in drug safety or a related field; Master/Diploma in Management degree is added advantage - Experience in the pharmaceutical industry, preferably in drug safety, pharmacovigilance, or clinical development - Knowledge of pharmacology, toxicology, and clinical trial methodology - Understanding of FDA and international regulatory requirements related to drug safety and pharmacovigilance - Strong analytical and problem-solving skills - Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams - Demonstrated ability to prioritize tasks and manage multiple projects simultaneously - Proficiency in data analysis tools (e.g., Excel, SAS) and safety databases (e.g., Argus, ARISg) - Good communication skils and relationship building skills - Act as SME for safety business and track industry trends relevant to safety - Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions - Responsible for improving capability presentations and Identifying service areas and solutions and work with the operational leadership to build capabilities - Participates in the analysis and definition of efficient, cost effective and creative solutions deliver competitive value propositions to the industry - Build partnership with senior leadership across the industry in Safety and PV - Represent the company in trade conferences, speaker sessions etc. - Identify and build potentially synergistic partnerships to expand client and service footprints - Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed Good to have EQUAL OPPORTUNITY

Principal Business Analyst What you will do Let’s do this. Let’s change the world. The role brings to bear domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. Roles & Responsibilities: Collaborate with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals Capture the voice of the customer to define business processes and product needs Work with Product Managers and customers to define scope and value for new developments Collaborate with Engineering and Product Management to prioritize release scopes and refine the Product backlog Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog Translate complex business and technological needs into clear, actionable requirements for development teams Ensure Acceptance Criteria and Definition of Done are well-defined Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators Develop and implement effective product demonstrations for internal and external collaborators Maintain accurate documentation of configurations, processes, and changes Serve as a liaison between global DTI functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 8 - 10 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree with 10 - 14 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma with 14 - 18 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience in writing requirements for development of modern web application Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Preferred Qualifications: Demonstrated expertise in a clinical development domain and related technology needs Experience in managing product features for PI planning and developing product roadmaps and user journeys Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Jira Align experience Knowledge of Cloud Platforms (AWS, Azure, GCP) and Enterprise infrastructure technologies. Experience of DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

RoleClinical & Therapy Development Manager Type Full Time Job description - Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo CT imaging modalities and complete the case support and proctor delegate authorizations. - Provide active commercial case support, demonstrating excellence in procedural success rates patient outcomes. - Scrub in sterile and provide TAVI valve loading in procedures training instruction to trial and commercial customers - Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program - Lead customer didactic education sessions for account activation before first implants - Lead pre case planning debriefing of heart team pre post procedure and provide ongoing education as requested for proper in - service levels - Provide documentation as required for quality assurance initiatives - Co-develop commercial business plan for assigned region - Co-support internal/external quarterly business reviews - Data entry into Salesforce, Mentor software for customer case support management - Learn commercial data analytics, resources tools for effective customer experience - Support customer engagement strategy with Marketing team (TM)) - Demonstrate competency with marketing messaging, clinical evidence and medical education portfolio offering - Demonstrate knowledge in the TAVI market, industry competitive insights - Participate in team meetings, conventions, and national sales meetings as requested - Drive innovative marketing and referral activities in collaboration with the markeitng team - Collaborate with the Sales and marketing team to conduct targeted market development in India Sub-continent. - Lead organization and delivery of key symposia by supporting discussions with customers to define agenda topics, select appropriate speakers / chairs, create required materials for events. - Develop Key Opinion Leaders within this segment to create market for the new therapies which will be launched and create advocates for your product who will speak on various forums - Identify high potential international / national referral community meetings to target for market development and collaborates with sales management team to put forward case for investment (program contributions / symposiums / workshops) This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Job Title: Senior Scientist - In Vitro Secondary Pharmacology Career Level: D Introduction to role: Are you ready to make a significant impact in the world of drug discovery and developmentJoin AstraZenecas Clinical Pharmacology Safety Sciences (CPSS) department, where innovation meets collaboration. Our Safety Innovation team is at the forefront of advancing a diverse pipeline across therapeutic areas, delivering safety science from early discovery through clinical development. We are seeking a talented in vitro pharmacologist to join our Secondary Pharmacology team, contributing to the clinical advancement of new medicines. Accountabilities: In this pivotal role, youll leverage your expertise in pharmacology, toxicology, and biology to collaborate with drug safety specialists and project safety pharmacologists. Your insights will shape drug design during the early phases of discovery, ensuring the selection of safer molecules and developing strategies to mitigate safety risks. Youll generate in vitro pharmacological profiling data at contract research organizations (CROs), identify off-target risks, and interpret pharmacological interactions. Your work will translate in vitro activity into pre-clinical and clinical adverse events, providing crucial guidance for project decisions. Essential Skills/Experience: PhD or Masters or equivalent experience in a relevant scientific field with 4+ years of industrial experience. A strong background in pharmacology (e.g., pharmacology, biology, biochemistry, toxicology, physiology) with a proven track record in driving innovative science, preferably in the pharmaceutical or biotechnology industry. Technical experience in in vitro pharmacological or biochemical assay development and screening (e.g., kinase profiling technologies, radioligand binding, enzyme activity, and functional cell-based systems) applied to various biological target classes. Excellent problem-solving and organisational skills, delivery focus, and outstanding communication skills. A true collaborator with highly effective networking skills and experience collaborating across scientific disciplines, cultures, and expertise. Desirable Skills/Experience: Experience with off-target profiling data and strategies in the pharmaceutical industry. Practical understanding of kinase profiling technologies. Experience working with CRO s, commissioning requests and driving delivery processes. Experience with being entrepreneurial taking the initiative in projects. Demonstrated leadership in scientific projects or teams. Experience in regulatory interactions or safety assessments. Knowledge of emerging trends in drug safety and pharmacovigilance. At AstraZeneca, we are driven by curiosity and courage, exploring what science can achieve. Our commitment to making a difference is unwavering as we fuse data and technology with scientific innovation to tackle some of the worlds most complex diseases. We celebrate successes and learn from failures, creating an inclusive environment where diverse knowledge is leveraged for swift impact on disease. With opportunities for lifelong learning and career growth, AstraZeneca is where you can push boundaries and deliver life-changing medicines. Ready to make a differenceApply now and be part of a team that transforms patient lives through groundbreaking science! Date Posted 23-May-2025 Closing Date 03-Jun-2025

This role is responsible for managing the external vendor and partner engagements, as we'll as product and program management and communication efforts for the Technology Systems team of the Patient Safety and Pharmacovigilance (PSPV) function. This role ensures the successful execution of programs and operations of technology products in line with strategic and operational goals and maintains effective collaboration with external partners as we'll as with internal stakeholders. About the Role Major accountabilities: Develop and maintain strong relationships with key strategic partners and vendors for Technology delivery for PSPV. Advise function leadership on best practices for supplier engagement and strategy. Leverage partner capabilities to deliver differentiated PSPV technology products and services based on knowledge of internal system architecture needs and strategic evolution, as we'll as external trends and best practices Actively oversee the engagement of key service providers in collaboration with the Procurement function, monitor vendor performance, and ensure adherence to contractual agreements. Provide leadership and guidance for key strategic programs in PSPV by applying best practices in project and program management. Identify and mitigate risks and issues in program and project execution, as we'll as day-to-day operations. Lead the application of enterprise-level Program Management Governance framework and best practices within PSPV programs. Serve as the change management and communication lead for the Technology Systems team within PSPV. Deliver timely updates on project and operational milestones, achievements, issues, and risks to relevant stakeholders. Oversee training curricula and capability-building initiatives for the Technology Systems team based on a thorough understanding of organizational strategy and priorities. Key performance indicators: Strength and effectiveness of vendor relationships. Successful execution and delivery of PSPV projects and programs within scope, time, and budget. Effective risk and issue management in project execution. Quality and timeliness of communication with stakeholders. Capability advancement for Technology Systems team Minimum Requirements: Work Experience: Minimum of 5 years of experience in a Senior Technology or Business role within the Life Sciences industry. Experience in technology vendor management in a multi-national corporation. Proven ability to manage complex projects and programs. Strong relationship-building skills with partners and vendors. Strong communication and presentation skills. Ability to manage multiple priorities and work effectively in a fast-paced environment. Experience in change management and driving organizational improvement initiatives, including organizational capability building. Preferred: Knowledge of business processes in Patient Safety and Clinical Development and thorough understanding of GxP requirements. Languages : Fluent in spoken and written English

Provide highly advanced expert support functional and technical leadership to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Develops and applies biostatistics and programming methods to ensure valid conclusions. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other RD areas. To meet challenges in data review, big data, analytics and reporting of clinical trial data may also Independently provide timely and professional leadership of special projects that focus on innovative tools and systems -Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. May lead global teams Key Responsibilities Study Level- Responsible for all statistical tasks on assigned clinical or non-clinical trials, and perform these tasks for high complexity trials with a high level of independence seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, and reporting activities. Contribute to planning and execution of exploratory analyses, innovative analyses related to publications and pricing reimbursement submission and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs and dose-finding strategies in alignment with the Lead Statistician. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, pricing agencies and other drug development activities, as required. Independently lead interactions with external review boards/ethics commit-tees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the clinical trial team and Biostatistics Pharmacometrics team. Independent oversight of all Biostatistics resources and deliverables for as-signed trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project Level- Responsible for strategic statistical input and influence into one or more projects (development plan, regulatory strategy, publication strategy, pricing reimbursement strategy, statistical deliverables). May be a core member of one or more early project teams representing Bio-statistics and Pharmacometrics. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful im-pact on robust drug development plans. Collaborate cross-functionally (eg, with data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables. Facilitate seamless transition of projects from early to late development. Effective partnership with other functions to ensure integrated quantitative in-put into project. Propose and implement innovative designs and methods to optimize drug development. Plan, prioritize and oversee project level statistical activities and ensure efficient resource management and effective partnership with vendors. Drive adherence to organizational standards and regulatory guidelines. Represent Biostatistics and Pharmacometrics at internal and external decision boards (eg regulators) Significantly contributes to project team preparation and may play a prominent role representing Biostatistics at HA meetings. Disease Area / TA/Indication level: As partner to clinical and scientific leadership, drive strategic statistical input and excellence to development programs within the assigned TA/DA/indications. Franchise or Global Line Function level: Lead or significantly contribute to initiatives at global line function level, or cross-functional Franchise level, requiring coordination of diverse of team members. May contribute to line function review. Enterprise level: Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Represent Biostatistics in due-diligence teams for low- to mid-complexity in-licensing opportunities with supervision. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and outside the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewe'd journals, presentations and chairing sessions at professional meetings. External: Represent Biostatistics and Pharmacometrics in interactions with external re-view boards/ethics committees, external consultants and other external parties with increasing independence. Chair sessions at professional meetings. People Management: Develop and mentor statisticians. As a local manager, responsible to recruit, retain and professionally develop up to 8 biostatisticians. Role Requirements- MS (in Statistics or equivalent) with 10+ years relevant work experience or PhD (in Statistics or equivalent) with 6+ years relevant work experience Fluent English (oral and written) Strong interpersonal and communication skills bridging scientific and business needs. Effective utilization of innovative statistics and quantitative analytics to influence assigned program team decisions and support department to deliver objectives. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Demonstrated excellence in use of statistical software packages (eg SAS, R). Strong knowledge of drug development and Health Authority guidelines. Experience independently leading a multidisciplinary team to achieve team objectives. Expert skills to facilitate and maximize the contribution of quantitative team. Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign. Strong understanding of Franchise/Therapeutic Area and or regulatory activities. Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies. May have proven people leadership ability. Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates. Good business ethics

Ensure compliance with internal and external guidelines, to compile and add electronic navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities (HAs) and provide publishing consultancy to the clinical teams and other line functions. Major accountabilities: In collaboration with the clinical teams, compile, integrate and publish clinical documents with word processing, electronic publishing, and document management systems in the Novartis Development environment. Perform technical quality control (electronic functionality, adherence to internal and external document standards) of published documents. Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements. Under direct supervision of the immediate manager, acts as the Program Publisher for various programs in clinical development. Key performance indicators: Publish clinical documents (taking into account complexity and size) in accordance with department standards and organization KPIs. Ensure published clinical documents meet current internal and external quality standards for electronic and/or paper HA submissions, including minimizing publishing-related technical QC findings and no rework once finalized. Timeliness of deliverables meet both individual document and overall project timelines. Minimum Requirements: Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria. Effective interpersonal skills, strong written and oral communication and presentation skills. Project management and time management skills to manage multiple ongoing projects simultaneously. Familiar with regulatory requirements and HA guidance, including FDA regulations, ICH and EMA guidelines/directives. Working knowledge of regulatory affairs. Works independently and with minimal supervision. Proficiency with computer programs/systems (MS office, etc) with demonstrated ability to learn new systems quickly. Analytical skills and problem solving skills. Ability to coordinate and work effectively with cross-functional teams. Work Experience: Cross Cultural Experience. Functional Breadth. Collaborating across boundaries. Operations Management and Execution. Project Management. Skills: Clinical Study Reports. Data Analysis. Documentation Management. Lifesciences. Operational Excellence. Regulatory Compliance. 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.

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

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.

Assistant Revenue Accountant ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development . Overview of the role Revenue Calculations: 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 What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Fortis Hospital Mohali is hiring for Head Clinical Pharmacology interested candidates can share profile at baljinder.singh@fortishealthcare.com

Career Category Regulatory Job Description Career Category Regulatory Job Description Let s do this. Let s change the world. In this vital role you will maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities. Roles Responsibilities: Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents; Conduct the formal review and approval of authored documents, following applicable standard operating procedures; With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications; Serve as functional area lead on product teams (e. g. , Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) May provide functional area input for Global Regulatory Plan and team goals May work with contract and freelance writers May participate in training and mentoring of junior medical writers May participate in departmental and cross-departmental initiatives, as appropriate. Generate document timelines, with team input Keep abreast of relevant professional information and technology What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of directly related experience OR Bachelor s degree and 6 to 8 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Preferred Qualifications: Functional Skills: Proficiency with word processing and other Microsoft Office Programs Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds; Ability to understand and follow complex standard operating procedures (SOP s), guidance documents, and work instructions; Understanding and application of principles, concepts, theories and standards of scientific/technical field. Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance s and requirements. Soft Skills: Excellent written/oral communication skills and attention to detail Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment; Proficient time and project management skills. Self-starter with a drive and perseverance to achieve results What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers. amgen. com .

Key Responsibilities 1. Clinical Oversight Ensure adherence to treatment protocols and SOPs across all units. Monitor clinical indicators, patient outcomes, and audit reports. Guide units on medico-legal processes, compliance, and NABH standards. Review critical incident reports and follow up on action taken. Provide clinical direction during health emergencies or outbreaks. 2. Administrative Coordination Supervise hospital operations remotely through MIS, dashboards, and unit-level coordination. Support policy implementation and resolve escalated clinical-operational issues. Standardize workflows across departments in consultation with Unit Heads. Facilitate inter-unit coordination to maintain continuity of care. Monitor implementation of hospital-wide initiatives and strategic plans. 3. Consultant Recruitment & Review Lead the recruitment and credentialing of Consultant Doctors across Secure units. Periodically review consultant performance and clinical alignment with hospital standards. Coordinate with HR and unit heads for manpower planning and onboarding. Ensure compliance with credentialing, licensing, and renewal protocols. Advise on distribution of specialties based on patient demand and hospital goals. 4. Resource & Budget Oversight Review department budgets, resource utilization, and staffing data. Advise on cost-effective service delivery and equipment use. Support finance teams with clinical input on billing justifications and service coding. Recommend clinical resource optimization across multiple units. Track utilization trends and suggest corrective actions as required. 5. Compliance & Stakeholder Liaison Ensure legal, ethical, and clinical compliance through remote monitoring. Coordinate with regulatory bodies and represent hospital in external audits or legal matters as needed. Oversee medico-legal documentation and court-related submissions. Maintain liaison with empanelment bodies, insurers, and public health officials. Review compliance reports and initiate policy-level improvements when needed. 6. Strategic & Clinical Advisory Support new clinical programs, specialty launches, and service upgrades. Analyze patient feedback and recommend service improvements. Guide digital health initiatives and clinical innovation efforts across units. Identify emerging healthcare trends for long-term planning. Collaborate with leadership on enhancing Secure Hospitals clinical reputation. Strong Experience in Hospital Leadership or Medical administration. Note : Prospective candidate should be open for travelling to all the Units as part of the job as and when it is necessary. Min 7 to 10 days of Travelling in the 1st 6 months. After 6 months one can plan the Travelling Schedule according to the Requirement. Qualifications MBBS Hospital Admin qualification preferred 10+ years in hospital leadership or medical administration Strong remote coordination, compliance, and strategic planning skills Key Skills and Competencies: Strong leadership and decision-making abilities. Excellent communication and interpersonal skills In-depth knowledge of hospital management systems and clinical protocols. Ability to handle crises and manage conflicts. Familiarity with healthcare regulations and accreditation standards.

Let s do this. Let s change the world. In this vital role you will maximise domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. Roles & Responsibilities: Collaborate with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Work with Product Managers and customers to define scope and value for new developments. Collaborate with Engineering and Product Management to prioritize release scopes and refine the Product backlog. Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and customers understand how they fit into the product backlog. Ensure Acceptance Criteria and Definition of Done are well-defined. Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Develop and implement effective product demonstrations for internal and external collaborators. Maintain accurate documentation of configurations, processes, and changes. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience. Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in clinical development with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity Experience in writing requirements for development of modern web application Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Good-to-Have Skills: Demonstrated expertise in a clinical domain area and related technology needs. Understanding of software systems strategy, governance, and infrastructure. Experience in managing product features for PI planning and developing product roadmaps and user journeys. Familiarity with low-code, no-code test automation software. Able to communicate technical or complex subject matters in business terms Jira Align experience. Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology. Knowledge of cloud platforms (AWS, Azure, GCP).

Let s do this. Let s change the world. In this vital role you will leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality results from the team. Roles & Responsibilities: Collaborate with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Work with Product Managers and customers to define scope and value for new developments. Collaborate with Engineering and Product Management to prioritize release scopes and refine the Product backlog. Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and customers understand how they fit into the product backlog. Ensure Acceptance Criteria and Definition of Done are well-defined. Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Develop and execute effective product demonstrations for internal and external partners. Maintain accurate documentation of configurations, processes, and changes. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with 4 - 6 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree with 6 - 8 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma with 10 - 12 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience. Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in clinical development with technology. Experience with Agile software development methodologies (Scrum). Good communication skills and the ability to communicate with senior leadership with confidence and clarity. Experience in writing requirements for development of modern web application. Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA. Good-to-Have Skills: Demonstrated expertise in a clinical development domain area and related technology needs. Understanding of software systems strategy, governance, and infrastructure. Experience in managing product features for PI planning and developing product roadmaps and user journeys. Familiarity with low-code, no-code test automation software. Technical thought leadership. Able to communicate technical or complex subject matters in business terms. Jira Align experience. Knowledge of Cloud Platforms (AWS, Databricks) and GCP regulations. Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

Let s do this. Let s change the world. The role brings to bear domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. Roles & Responsibilities: Collaborate with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals Capture the voice of the customer to define business processes and product needs Work with Product Managers and customers to define scope and value for new developments Collaborate with Engineering and Product Management to prioritize release scopes and refine the Product backlog Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog Translate complex business and technological needs into clear, actionable requirements for development teams Ensure Acceptance Criteria and Definition of Done are well-defined Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators Develop and implement effective product demonstrations for internal and external collaborators Maintain accurate documentation of configurations, processes, and changes Serve as a liaison between global DTI functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with 8 - 10 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree with 10 - 14 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma with 14 - 18 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience in writing requirements for development of modern web application Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Preferred Qualifications: Demonstrated expertise in a clinical development domain and related technology needs Experience in managing product features for PI planning and developing product roadmaps and user journeys Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Jira Align experience Knowledge of Cloud Platforms (AWS, Azure, GCP) and Enterprise infrastructure technologies. Experience of DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

Oversee safety issues of projects conducted by ICON which will include, but not be limited to, the following: Adverse event reporting to the sponsor Follow up of adverse events as necessary Communication of safety issues to the head of the department or designee Participate in the on-call system for providing 24/7 medical support Provide all necessary medical support functions as defined by project specific contractual obligations which will include, but not be limited to, the following: Medical information source Ongoing training for project teams in therapeutic areas as requested Review of study documentation (protocol, CRF. etc.) Contribute to investigator meeting presentations Ongoing safety review of individual patient laboratory reports generated by central laboratories CRF safety review Contribute any necessary medical input into integrated clinical and statistical reports Assist in making presentations to potential clients when appropriate Demonstrate a thorough understanding of ICON Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs Demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations Keep the person to whom the Clinical Research Physician reports informed of any issues within the department which require attention Line management of DSAs as appropriate

Data Analyst II ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Data Analyst II to join our diverse and dynamic team. As a Data Analyst II at ICON, you will play a crucial role in analyzing complex datasets to support decision-making and enhance clinical operations and research processes. You will contribute to the advancement of innovative treatments and therapies by providing actionable insights and leveraging data analytics to drive performance across the organization. What You Will Be Doing: Conducting thorough data analysis to support clinical trial design and execution. Collaborating with cross-functional teams to identify opportunities for data-driven innovation and optimization within clinical research. Interpreting complex datasets to derive insights and inform strategic decision-making. Assisting in the development of data visualization and reporting tools to effectively communicate findings. Establishing partnerships with stakeholders to leverage data analytics and improve research outcomes. Your Profile: Bachelor s degree in Radiology and Life science. 1.5+ years of experience in different Imaging Modalities such as CT, MRI and more Strong analytical skills with the ability to translate data into actionable insights. Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Data Analyst II We are currently seeking a Data Analyst II to join our diverse and dynamic team. As a Data Analyst II at ICON, you will play a crucial role in analyzing complex datasets to support decision-making and enhance clinical operations and research processes. You will contribute to the advancement of innovative treatments and therapies by providing actionable insights and leveraging data analytics to drive performance across the organization. What You Will Be Doing: Conducting thorough data analysis to support clinical trial design and execution. Collaborating with cross-functional teams to identify opportunities for data-driven innovation and optimization within clinical research. Interpreting complex datasets to derive insights and inform strategic decision-making. Assisting in the development of data visualization and reporting tools to effectively communicate findings. Establishing partnerships with stakeholders to leverage data analytics and improve research outcomes. Your Profile: Bachelor s degree in Radiology and Life science. 1.5+ years of experience in different Imaging Modalities such as CT, MRI and more Strong analytical skills with the ability to translate data into actionable insights. Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply