177 Clinical Development Jobs - Page 7

Senior Specialist, Medical Advisor Oncology The Senior Specialist Oncology will be responsible for providing strategic support and expertise in oncology to drive the development and implementation of medical affairs initiatives. This key role will involve collaborating with cross-functional teams, including clinical development, marketing, and regulatory affairs, to ensure the successful launch of oncology pipeline. The Senior Specialist Oncology will also be responsible for building and maintaining relationships with key opinion leaders (KOLs), lead data generation initiatives, participating in scientific conferences, and contributing to the overall medical affairs strategy. Key Responsibilities: People Manager Role - Senior Specialist Oncologist will manage 2 field-based medical advisors focusing on West and South region of India. Provide strategic guidance and expertise in oncology for the development and execution of medical affairs plans focusing on Lung Cancer, GU Cancers and Hematology portfolio Collaborate with cross-functional teams to support the successful launch and commercialization of oncology products. Serve as a subject matter expert in oncology for internal teams, including clinical development, marketing, and regulatory affairs. Build and maintain strong relationships with key opinion leaders (KOLs) in the oncology field. Stay up-to-date with the latest scientific advancements, clinical trial data, and competitive landscape in oncology. Contribute to the development of scientific communications, including publications, presentations, and educational materials. Represent the company at scientific conferences, symposiums, and advisory boards. Provide support and training to the sales and marketing teams on oncology products and disease management. Collaborate with external stakeholders, including healthcare professionals, patient advocacy groups, and professional organizations. Ensure compliance with all applicable regulations and guidelines, including pharmacovigilance reporting and medical information requests. We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 04/15/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

We are seeking a highly skilled and motivated Clinical Research Medical Advisor (CRMA) to join our team. The CRMA will be accountable for all country clinical or medical aspects associated with Development and prioritized Research programs/trials. This role involves providing clinical strategic and tactical leadership, optimizing clinical trial implementation, and ensuring adherence to safety standards and clinical data quality. Job Description Key Responsibilities: - Provide clinical development and indication expertise specific to the country/cluster. Validate study designs and make final decisions on clinical/medical trial feasibility. Contribute to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up. Provide clinical/medical expertise to clinical trial operations team members and clinical trial sites for IRB/EC interactions. Develop clinical/medical trial plans to ensure successful trial implementation. Provide robust indication, compound, and protocol training to the clinical operations team and externally as needed. Support and partner with internal stakeholders regarding clinical trials. Essential Requirements:- Scientific degree MD/M.B.B.S Ability to manage a study from the scientific/medical/clinical perspective. Demonstrated capability to problem solve and mediate complex issues. Effective leadership and communication skills. Agility to move quickly across different therapeutic areas and indications. Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice. Sound understanding of the overall clinical development process and ICH/GCP principles.

Title: Associate Manager - Regulatory Solutions Date: 18 Feb 2025 Location: Bangalore, KA, IN We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations 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 What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it We understand that you are looking for growth and variety in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We hire the best and trust them from day 1 to deliver global impact, handle teams and be responsible for the outcomes while our leaders support and mentor you. We are a profitable rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you. If this excites you, then apply below. EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD EXPERIENCE: 10 to 12 years experience in writing Clinical Regulatory documents supporting global filings (CTD Module 2 and Module 5) ROLE PURPOSE: This role is responsible for handling complex Medical Writing projects and provide review support for medical writing deliverables that support the clinical regulatory writing portfolio along with training the junior writers. SKILLS: Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs,) protocols, amendments, ICFs amendments, and Investigator Brochures (IBs) Demonstrated excellence in focused/lean writing and editing following defined processes and templates Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questions Understanding of clinical development process from program panning to submission, including clinical trial design Communication skills commensurate with a professional working environment Effective time management, organizational, and interpersonal skills People management experience for more than 2 years Customer focus Comfortable following directions, templates, and structured processes for delivering documents for review and finalization Able to work independently while maintaining communication with the Sponsor s MW project manager Ability to move across Therapeutic Areas to support business continuity and resource needs Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines Develop work plan and ensure adherence Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion Adherence to processes and Sponsor-defined best practices Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements KNOWLEDGE REQUIREMENT: Scientific Knowledge Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries) Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science Understanding of medical practices regarding procedures, medications, and treatment for different disease states Manage messaging for consistency with historical information and in alignment with agreed-upon strategy Capable of providing insight, alternatives, and suggestions based on previous experiences Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring Experience writing protocols, amendments, CSR, and CTD summary documents Technology Skills Expert authoring in MS Word, understanding of MS Word functionality Experience working in document management systems; managing workflows eApproval/signatures Experience working with Word add-ins that facilitate the management of fonts, styles, references, etc. Flexibility in adapting to new tools and technology Capable of training writers/authors on the use of templates, guidelines, and tools RESPONSIBILITIES: Without guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission documents (Module 2 summarries), and other regulatory documents on investigational drugs in various stages of clinical development Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of authoring process Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines Develop and maintain project plans work plan for the team members People management Work as an active member of cross-functional teams representing Medical Writing Coordinate and deliver document kick-off meetings with writers and cross-functional representatives Ensure adherence to standard content, lean authoring, and messaging across team members Ensure communication between members remain open and information is disseminated appropriately Possible participation in the orientation and coaching of junior team members Conduct appropriate literature searches and screening, as needed Participate on Medical Writing department initiatives, as appropriate. Research regulatory requirements to remain current in the regulatory landscape Share lessons learned and best practices Ensure compliance with company training and time reporting EQUAL OPPORTUNITY

Job purpose The Manager/ Sr. Manager of Pharmacovigilance will navigate the complex landscape of clinical safety, on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and state of the art pharmacovigilance post approval. This role reports directly to the Chief Medical Officer at Ocugen. Duties and responsibilities As the Manager/ Sr. Manager of Pharmacovigilance, Clinical Quality, Safety and Pharmacovigilance, you will be tasked with applying sound judgment for the analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation. The role will require the identification and implementation of all clinical standard-operating procedures in order to ensure GCP compliance. The role serves as the senior clinical safety representative in the cross-functional development teams. You will be responsible for setting Ocugens clinical safety strategy for these global projects. The role identifies potential challenges, risks and roadblocks associated with the global safety domain and works as a leader in developing solutions to address these. The role ensures that the medical and process standards delivered at Ocugen are in alignment with following safety objectives expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients, and the general public. Responsibilities include overseeing the safety signal detection and medical signal evaluation process and analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion. Providing a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unblinding clinical data to protect ongoing study participants and complete timely communications to Health Authorities Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards. Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication. Review and contribute to safety relevant SOP and improvement of safety relevant SOPs. Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety. Ensures regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function. Set safety strategy based on strong product knowledge and biologicals safety experience that allows for successful IND (Investigational New Drug)/NDA (New Drug Application) filings and initiation of first in human studies. Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports. Oversees development of core safety information for new products Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in Ocugen’s studies. Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment including many interface departments and functions. Complies with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities: Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure Promoting the safe and effective use of medicinal products through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public Contributing to the protection of patients and public health The role identifies tools necessary to facilitate safety surveillance and clinical safety assessment and to implement necessary risk management initiatives. Provides input into clinical development, due diligence, regulatory and issue management activities from a clinical safety perspective and represents the position of GCSP in internal governance committees and in discussions with Health Authorities Qualifications Eight(8) to Thirteen (13) years pharmaceutical/biotechnology industry experience, of which at least six (6) should be in a safety role, with broad overview of all aspects of a PV system and specific experience in signal detection and risk management. Experience and success in addressing and managing complex safety issues in the pre-approval and post-approval environment including interfacing with external regulatory bodies (written and verbal interactions. e.g. External Audits, Ad Coms, CHMP Oral Explanations, etc.) Knowledge of scientific data relevant to own products and across therapeutic area, including the competitive environment and the disease state Strong understanding of data capture, data management and statistical methods for the preparation and analysis of safety data in clinical trials Detail oriented, exceptional documentation practices, technical writing, and verbal communication skills. Ability to convey complex concepts through clear and concise messages. Excellent problem-solving skills, contingency planning, and risk-mitigation strategies Ability to navigate and be successful in a fast-paced, highly matrixed work environment. Working conditions This position operates in an office setting and may include 20% of travel from time to time. Physical requirements This is a largely sedentary role.

Data Analyst II, Chennai 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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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 requirementsWe 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 EmployeePlease click here to apply

We are seeking a highly motivated and compassionate recent graduate to join our clinical team as an Entry-Level Clinical Assistant/Clinical Associate. This is an excellent opportunity to gain hands-on experience in a clinical setting and contribute to patient care or clinical research. You will work closely with physicians, nurses, and other clinical staff, assisting with various tasks related to patient care, data collection, and administrative support. This role is ideal for individuals with a strong interest in healthcare and a desire to learn and grow in a dynamic environment. Responsibilities: Patient Care Support: Assist with patient intake and vital sign measurements. Prepare examination rooms and ensure they are clean and stocked with supplies. Provide basic patient support and comfort. Assist with the administration of basic medical procedures under supervision. Clinical Data Management: Accurately collect and record patient data in electronic health records (EHR) or clinical research databases. Assist in the preparation of clinical reports and data summaries. Maintain accurate and organized clinical records. Ensure data integrity and confidentiality. Administrative Support: Schedule patient appointments and manage patient flow. Answer phone calls and respond to patient inquiries. Assist with filing, photocopying, and other administrative tasks. Maintain inventory of clinical supplies. Clinical Research Support (if applicable): Assist with the recruitment and screening of clinical trial participants. Assist in the administration of study procedures and data collection. Maintain study documentation and regulatory files. Ensure adherence to study protocols and ethical guidelines. General Support: Assist clinical staff as needed. Participate in team meetings and training sessions. Maintain a clean and organized work environment. Any other duties as assigned. Qualifications: Bachelor's degree in a Life Science, Healthcare, or related field (e.g., Biology, Nursing, Psychology, Public Health). Strong interest in patient care or clinical research. Excellent communication and interpersonal skills. Strong attention to detail and accuracy. Ability to work independently and as part of a team. Strong organizational and time-management skills. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Must be a recent graduate.

We are seeking a Senior Specialist Programmer for PKPD / Pharmacometric Data Programming. This role focuses on all aspects of data preparation, programming, validation, and diagnostics to support Pharmacometric and clinical pharmacology analyses at the study levels. You will be instrumental in influencing critical decision-making throughout all phases of drug development and regulatory interactions. Accountabilities: As a Senior Specialist Programmer, you will be accountable for expert data integration, manipulation, and preparation results at the study level. You will execute state-of-the-art data preparation techniques with direct value for the study. Your responsibilities will include collating, cleaning, and preparing analysis-ready data for Pharmacometric Modeling and Simulation (M&S) software (e.g., NONMEM) to influence study designs and go/no-go decisions. You will also contribute to regulatory documents and interactions, internal initiatives to develop the Pharmacometric discipline, and compliance with Good Clinical Practice (GCP) regulations. Essential Skills/Experience: Proficient oral and written English communication skills Demonstrated expertise in data preparation and programming to support Pharmacometric Modeling and Simulation (M&S) software (e.g., NONMEM, Monolix, R, Matlab) Strong SAS/R programming skills Expert knowledge of data preparation and programming practices (CDISC, SDTM, ADaM) Demonstrated data programming and clinical development expertise Good knowledge of global regulatory, compliance, processes, standards Bachelor s degree or Masters preferred with 5 to 8 years relevant experience required Varied programming languages (SAS, R, Python) Experience in early and late-stage drug development Quantitative/Scientific background (Statistics, Engineering, Biological Science) Desirable Skills/Experience Scientific publishing in the field of pharmacometrics Knowledge in pharmacology, drug targets, and core Therapy areas (e.g., Oncology, Respiratory, Renal Metabolism etc.) Relevant regulatory experience

Introduction to role The Associate Director Statistical Programming is accountable for leading, managing, and developing a team of programmers. They present a delivery/department approach and leadership skills to run and be responsible for one moderate scope and complexity drug project or multiple smaller ones. As a recognized expert within their own field, they are often the first point of contact for related queries, act as a coach or mentor for staff, and act as a specialist within cross-functional teams to deliver continuous improvement. Accountabilities Leads, manages, and develops a group of programmers, providing guidance and mentorship. Manages training and timesheet compliance Work according to agreed functional and regional SHE strategy by ensuring proper management of SHE risks, incidents, reporting, follow-up, and improvements. Arranges and structures the team in order to create an environment where the team can work productively and collaboratively together Defines, monitors, and assesses objectives for the team Provides input to capacity management for all projects in scope Captures business needs and plans recruitment accordingly Recruits and builds the team with the appropriate skills Maintains talent and ensures talent development Maintains own and team knowledge of the latest industry and regulatory requirements to stay current in the Programming practices Leads Implementation of statistical programming aspects of the protocol or clinical development program Acts as technical subject matter expert for aspect(s) of the TA, Project, or function Manages activities of our external partners (i.e. Contract Research Organizations) Accountable for managing contracting staff Manages and advances risk in complicated or novel situations within their study and/or projects Overall accountability for the quality and compliance to internal, external, and regulatory requirements for the delivery of programming aspects in clinical development; holds partners and providers accountable for the quality of their deliverables Leads or participates in cross-functional administrative or process improvement initiative(s) Drives the continuous improvement of the team and function through personal action and process initiatives Drives the development of standard methodologies to improve quality, efficiency, and/or effectiveness within function Contributes to the function by providing training and mentorship Influences team members by providing subject matter expertise on programming-related items Drives standards development and implementation Measures the compliance of and ensures that there is a consistent approach to data standards and automation and its implementation Collaborates/influences cross-functionally and represents Programming leadership where required. Essential Skills/Experience Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science, or equivalent experience Thorough knowledge of the clinical development process Thorough knowledge of industry standards Demonstrated leadership capability and proven ability to lead teams towards a common goal Demonstrated planning and organizational skill Ability to influence relevant partners and global teams Ability to develop individuals Ability to manage risk in complicated or novel situations Current knowledge of technical and regulatory requirements relevant to the role Project mindset Desirable Skills/Experience Experience implementing business processes Willingness and ability to travel Experience in problem-solving and conflict resolution skills When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. Thats why we work, on average, a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, we play an essential role in helping patients who need it the most. Our high exposure roles allow us to shape end deliverables and embrace global opportunities across all Therapy Areas. With a restless need to keep improving, we are always moving forward, searching for new solutions. Our supportive yet exciting approach creates an inspiring learning environment where every setback is seen as a chance to improve. We combine specialist knowledge with curiosity, always seeking better ways to achieve the best results. Working here means dedication, resilience, and a smart approach to new challenges. We harness science to make decisions that put patients first, demonstrating diverse minds for success. Our work is recognized across the enterprise, empowering us to make a profound impact with research that makes a tangible difference. Ready to make an impact? Apply now! Date Posted 06-Mar-2025 Closing Date 30-Mar-2025

Client Services Associate I - India, Bangalore - Hybrid, Office-Based 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 The role: This is an exciting opportunity to join the Client Management side of our Contracts team within the Clinical Research Industry. Do you have an interest in negotiation, Contracting and budgeting, putting your client management skills to use, while focusing on excellent customer serviceIf you are looking to join a company which will offer you a strong support network with an inspiring and motivating working environment, then this is the job for you! Our Contracts team is part of our Global Business Services group who are based at our offices in Dublin, Ireland. The team provides the coordination and management of Contracts and Change orders for clinical Research projects for external clients. Client Services Associate I responsibilities include but are not limited to: budgeting, Drafting Contracts and Change orders, client relationship management and timeline planning. You will need: As the client s main point of contact throughout the lifetime of a Contract drafting to execution, successful candidates must possess exceptional communication and customer service skills. Applicants must also be able to demonstrate drive, passion, great attention to detail and be comfortable managing a variety of tasks at one time. A background/qualification in Languages, English, Marketing or Business is preferred but not essential. In addition: Fluency in English both orally and in writing with excellent communication skills Strong teammate Experience in managing multiple, varied tasks simultaneously and independently MS Office Suite Previous experience in the clinical Client contracts- not mandatory 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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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 requirementsWe 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 EmployeePlease click here to apply

We are seeking a highly organized and detail-oriented Clinical Trial Coordinator (Fresher) to join our dynamic clinical research team. In this role, you will play a crucial part in ensuring the successful execution of our clinical trials from start to finish. You will collaborate with a multidisciplinary team of researchers, investigators, and study personnel to coordinate all aspects of clinical trial operations. Key Responsibilities: Study Coordination: Coordinate the day-to-day activities of assigned clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements. Site Management: Assist in site selection, initiation, monitoring, and close-out activities. Documentation: Maintain accurate and complete study records, including case report forms, source documents, and regulatory binders. Communication: Facilitate effective communication between study sites, sponsors, investigators, and internal team members. Data Management: Ensure timely and accurate data collection, entry, and query resolution. Regulatory Compliance: Ensure compliance with all applicable regulations, guidelines, and standard operating procedures. Patient Recruitment: Support patient recruitment and retention efforts. Training: Provide training and support to study staff on study protocols and procedures. Quality Assurance: Participate in quality control activities and internal audits. Qualifications and Skills: Education: Bachelor's degree in life sciences, nursing, or a related field. Experience: Fresher or recent graduate with a strong interest in clinical research. Knowledge: Basic understanding of clinical research principles and Good Clinical Practice (GCP). Skills: Excellent organizational, communication, and interpersonal skills.

Job Type- Fresher or Internship level Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe. Responsibilities: 1. Assist in Protocol Development: Collaborate with the clinical research team to contribute to the development and review of clinical trial protocols. 2. Site Identification and Selection: Participate in the process of identifying and selecting clinical trial sites by conducting feasibility assessments. 3. Regulatory Compliance: Support the team in ensuring regulatory compliance throughout the clinical trial process. Assist in the preparation and submission of regulatory documents to appropriate health authorities. 4. Site Initiation: Assist in the initiation of clinical trial sites by coordinating site training activities and ensuring that all necessary documentation is in place. 5. Monitoring and Data Collection: Work closely with clinical research associates and investigators to monitor and collect data during the clinical trial. Assist in ensuring data accuracy, completeness, and adherence to protocol. 6. Adverse Event Reporting: Contribute to the process of monitoring and reporting adverse events, ensuring compliance with regulatory requirements. 7. Study Close-Out: Participate in the close-out activities of clinical trials, including the collection of essential documents and finalizing study reports. 8. Collaboration and Communication: Work collaboratively with cross-functional teams, including clinical operations, data management, and regulatory affairs. Communicate effectively with investigators, site staff, and study sponsors. 9. Documentation and Record Keeping: Maintain accurate and up-to-date documentation of all activities performed during the internship. Contribute to the development and organization of the trial master file. 10. Learning and Development: Actively engage in learning opportunities provided during the internship to enhance knowledge of clinical research processes and industry regulations. Qualifications: Currently enrolled in a Bachelor's or Master's degree program in a related field (e.g., Life Sciences, Pharmacy, Nursing, etc.). Excellent communication and interpersonal skills. Detail-oriented with strong organizational and time management abilities. Ability to work independently and as part of a team.

Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management and completes project programming activities within timeframe allotted. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kick-off meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Transfers deliverables. Performs other work-related duties as assigned. Minimal travel may be required. Qualifications What we re looking for Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Minimum of 5 years of experience in clinical SAS programming. Experience of working on ADaM datasets and TLFs generation along with understanding of SAS/Macros. Excellent written and verbal communication skills. Ability to read, write, speak and understand English.

Lead and manage the end-to-end implementation of the Epic EHR system. EPIC Certification mandatory. Collaborate with cross-functional teams For Philippines location

Creates catalogue of reports to aid data cleaning activities with low to medium complex in scope, but not limited to: Automate manual checks. Automate reconciliation and program edit checks for TPV data to ensure quality. Create tools and repository to minimize data errors at source for collection of lab reference ranges. Program reports to identify missing pages and detect errors at Subject level. Create reports to measure metrics that can help assess data cleaning status. Create visualizations and dashboards to identify discrepancies and trends in EDC and TPV data Contribute to implementation of cross-functional projects that are part of clinical programming roadmap Collaborates with various teams including data management, development operations, clinical, biometrics and other relevant multi-functional teams supporting clinical trials to deliver end user reporting needsClinical Programmer responsibilities include (but not limited to) design, development, implementation and validation of programs created in SAS/Python/R/SQL or dashboard applications such as PowerBI/Spotfire/MicroStrategy, to process, analyze and report clinical trial data for review by clinical study teams. BachelorS degree or equivalent in computer science, life science or statistics Good programming skills and Prior experience in SASPythonRSQL. Good skills and Prior experience in business intelligence technologies as Power BI, MicroStrategy Good understanding of Data Collection and Industry data standards Prior understanding of EDC systems like Medidata Rave Inform Veeva etc Basic knowledge of clinical development process Programming : Python/SAS/SQL Data Visualization and Analytics skills : MicroStrategy POWERBI or other BI tools Tools(Desirable) : Exposure towards Saama/ SAS LSAF Domain (Desirable): Knowledge of Clinical Trail Life Cycle and Data Management

Job Title: Senior Statistical Programmer I Career Level - D Introduction to role The Senior Statistical Programmer I is a delivery-focused role responsible for programming deliverables with quality and timeliness, following established standards and processes. This position requires technical skills and adequate industry knowledge to independently perform programming tasks while using judgment about seeking guidance in complex situations. You will support medium complex clinical study deliverables or part of project deliverables. Acting as a contributor on cross-functional teams, or a lead on small teams, you will drive continuous improvement. Accountabilities - Collaborate with other team members to provide programming support to deliver technical programming and information components of a study or a project deliverable - Implement statistical programming aspects of the protocol or clinical development program - Ensure high quality is built into own deliverables and the deliverables of other programmers on the team - Program independently with efficiency and quality - Write specifications and oversee completeness of relevant documentation - Contribute to the development of best practices to improve quality, efficiency, and effectiveness within function - Ensure compliance to standards and automation usage - Initiate team activities and tasks - Identify and communicate risk within the assigned studies and/or projects - Work cooperatively with study team members including but not limited to the statistician, lead programmer, data manager, and study leader - Work cooperatively with contract programming providers - Contribute to technical initiatives - Employ basic project management practices in managing programming aspects of drug or technical projects Essential Skills/Experience - Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent. - Accomplished programming skills including macro language - Intermediate knowledge of the clinical development process - Good knowledge of industry standards - Implements project management practices - Ability to apply programming knowledge to problem solving - Ability to manage relevant documentation. Desirable Skills/Experience - Ability to proactively manage concurrent activities within their assigned study(ies) or project. At AstraZeneca, we are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. Our inclusive environment allows us to work seamlessly as one, leveraging our diverse global knowledge to create the greatest impact on disease. We are always listening and learning from people who live with the diseases our medicines treat, enabling us to better understand their needs and design the right treatments. Ready to make a meaningful impact? Apply now and join us on this exciting journey! Date Posted 04-Mar-2025 Closing Date

Introduction to role The Associate Director Statistical Programming is accountable for leading, managing and developing a team of programmers. They showcase an approach dedicated to delivery/department and possess leadership skills to lead and supervise a moderate scope and complexity drug project or multiple smaller ones. As a recognized expert within their own field they are often the first point of contact for related queries, acts as a coach or mentor for staff, and acts as a specialist within cross-functional teams to deliver continuous improvement. Accountabilities Leads, manages and develops a group of programmers, providing guidance and mentorship. Manages training and timesheet compliance Work according to agreed functional and regional SHE strategy by ensuring proper management of SHE risks,incidents, reporting, follow-up and improvements. Arranges and structures the team in order to create an environment where the team can work productively and collaboratively together Defines, supervise and assess objectives for team Provides input to capacity management for all projects in scope Captures business needs and plans recruitment accordingly Recruits and builds the team with the appropriate skills Maintains talent and ensures talent development Maintains own and team knowledge of the latest industry and regulatory requirements to stay current in the Programming practices Leads Implementation of statistical programming aspects of the protocol or clinical development program Acts as technical subject matter expert for aspect(s) of the TA, Project, or function Manages activities of our external partners (i.e. Contract Research Organisations) Accountable for managing contracting staff Manages and advance risk in complicated or novel situations within their study and/or projects Overall accountability for the quality and compliance to internal, external and regulatory requirements for the delivery of programming aspects in clinical development; holds partners and providers accountable for the quality of their deliverables Leads or participates in cross-functional administrative or process improvement initiative(s) Drives the continuous improvement of the team and function through personal action and process initiatives Drives the development of standard methodologies to improve quality, efficiency and/or effectiveness within function Contributes to the function by providing training and mentorship Influences team members by providing subject matter expertise on programming related items Drives standards development and implementation Measures the compliance of and ensures that there is a consistent approach to data standards and automation and its implementation Collaborates/influence cross-functionally and represents Programming leadership where required Essential Skills/Experience Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science, or equivalent experience Thorough knowledge of the clinical development process Thorough knowledge of industry standards Demonstrated leadership capability and proven ability to lead teams towards a common goal Demonstrated planning and organisational skill Ability to influence relevant team members and global teams Ability to develop individuals Ability to manage risk in complicated or novel situations Current knowledge of technical and regulatory requirements relevant to the role Project approach Desirable Skills/Experience Experience implementing business processes Willingness and ability to travel Experience in problem solving and conflict resolution skills Date Posted 04-Mar-2025 Closing Date 30-Mar-2025

Description Statistical Programmer II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job responsibilities Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Completes project programming activities within timeframe allotted by Lead Statistical Programmer and/or management. May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables. Assists with the transfer of deliverables. Performs other work-related duties as assigned. Minimal travel may be required. Qualifications What we re looking for Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience. Proficiency in programming in SAS or other required software, preferably in a clinical trial environment. Requirement - R Programmer(s): External Anonymized Dataset production Require Statistical Programmer II (2-4yrs); Sr Statistical Programmer (5-8yrs); Principal Stat Programmer (8yrs above) relevant experience in Clinical SAS SAS/SQL, R programming skills Hand on experience in Anonymization of Clinical Datasets will be given weightage Experience in Github / GitLab preferred SDTM / ADaM Theoretical knowledge and SDTM hands on experience will be value added. Excellent written and verbal communications skills. Capable Programmer(s) with proven R (R Studio) skills. SQL experience will be useful to write conditions for data redactions. As code is managed using Git\Gitlab any experience in this area will also be useful. Some knowledge of Python may be useful e.g. to look at code / outputs. Good eye for detail to review clinical data pre- and post-processing from the anonymization ruleset tool. This includes review for Personal Protected Information (PPI) based on the ruleset provided or variables/observations do not present in the ruleset. Knowledge of the drug development process (Phase I through IV) and general regulatory requirements. study lead experience and capable of managing multiple studies. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. .

About us At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you re our kind of person. In assigned therapeutic area and geographical territory, engages in clinical and scientific exchange with medical and scientific experts, including Healthcare Professionals, and where appropriate non-traditional stakeholders (e.g. policy and decision makers, PAGs, government, innovative solution providers) consistent with medical objectives. Scientific Expertise: Maintain clinical/scientific expertise in disease state management, AstraZeneca products, emerging therapies, and the competitive landscape. Contribute to the development and provide project leadership/ management of the therapeutic area Field MedicalStrategic Plan (FMSP). Act as a subject matter expert/resource for internal and external stakeholders. Work with internal stakeholders in the development and delivery of appropriate training and mentoring needs within therapeutic area. Scientific Exchange: Engage in peer-to-peer level dialogue with key customers and deliver appropriate clinical/scientific content through utilizing the correct channel mix, which will differentiate AstraZeneca products from those of other companies. Respond to unsolicited customer inquiries and provide focused and balanced clinical / scientific information that supports the safe and appropriate use of AstraZeneca s products and services. Provide scientific/clinical support and deliver presentations to internal and external stakeholders. Identify and establish relationships with key customers and other scientific thought leaders for engaging them in ongoing scientific dialogue on AstraZeneca products and unsolicited discussions about compounds in development. Organize and facilitate scientific events such as MSL events, Symposiums, Scientific Exchanges, Advisory Boards/Expert Panels, non-promotional standalone events, Meet the Professor sessions, etc., with KEEs and HCPs. Prioritize these events based on their relevance in the patient journey for the related disease. Deliver informative lectures at scientific events tailored to healthcare professionals, aligning with the field medical Communication strategy. Collaborate with KEEs on study proposals (ESR or Local Study) and/or publications of interest to AstraZeneca. Customer Insight: Effectively identify, gather, analyze, synthesize, report and forward relevant new knowledge about the external scientific/medical environments to internal stakeholders Provide internal stakeholders with actionable items related to medical / product strategy or clinical development based on customer perspectives. Partner with traditional and non-traditional stakeholders to identify gaps in the patient experience journey as insights to be included in the medical / product strategies. Strategic Relationship: Develop peer-level relationships with medical and scientific experts, including Healthcare Professionals and collaborate with other internal teams for other key external stakeholders (e.g. policy and decision makers, PAGs, government, innovative solution providers) consistent with Medical objectives. Identify pre-clinical, clinical, and post-marketing study investigators in alignment with Medical Plans. Support data generation activities including participating in reviews of Investigator sponsored studies. Looks to broaden the My MA contact list where appropriate to include non-traditional KEEs from government, payer groups, researchers and clinical advisors who may support practice change initiatives. Establish win-win partnerships with traditional and non-traditional stakeholders to deliver on strategic, scalable and sustainable solutions addressing patient healthcare access gaps within the ecosystem. Other: Responsible for leveraging digital and innovation / technology as enablers for scientific exchange and creating patient centric solutions. Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Exhibits a robust understanding of the Ethical Interactions Policy, along with relevant standards, local laws, and regulations. Moreover, possesses the ability to provide training to others in this domain. Adherence to internal processes and AstraZeneca Global Field Medical Standards and the external regulations including but not limited to clinical trials, promotional activity (e.g. Local Code of Conduct) and pharmacovigilance activities to meet internal SOP and local regulations. Education, Qualifications, Skills and Experience Doctoral degree in a scientific discipline (e.g. M.D., Ph.D., Pharm.D.) Experience in pharmaceutical industry, regulatory environment, clinical or preclinical research, and knowledge of a therapeutic area disease state and treatment. Experience with basic research, drug discovery, drug development and KEE interactions. Why AstraZeneca? At AstraZeneca we re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We re on an exciting journey to pioneer the future of healthcare. Date Posted 28-Feb-2025 Closing Date 27-Mar-2025

PV Country Head IN POSITION PURPOSE: The Pharmacovigilance Country Head (PVCH) is responsible for Pharmacovigilance (PV) in India, Nepal, Bangladesh, Bhutan and SriLanka working towards excellence to ensure the safe and appropriate use and the long- term medical potential of company s products. The PVCH is responsible and accountable for directing, managing and improving all. Pharmacovigilance activities for all Pharma and Consumer Health products, including contrast media products from Radiology according to India, Nepal, Bangladesh, Bhutan and Sri Lanka legislation and as devolved from Pharmacovigilance (PV). The PVCH provides medical safety governance to protect the patients, the products and the Bayer group with special focus on the India, Nepal, Bangladesh, Bhutan and SriLanka public health needs. The PVCH assures constant monitoring of national PV regulatory requirements and compliance with national and relevant international safety regulations. YOUR TASKS AND RESPONSIBILITIES: Leads and manages India, Nepal, Bangladesh, Bhutan and Sri Lanka PV team. Leads the local Safety Management Team and liaise with the relevant expert functions in the local Safety Risk Management Plan development and intervention implementation activities. Works with the PV Regional Centre (PVRC) and maintains oversight on appropriate execution of delegated tasks Provides guidance in all PV and safety matters: Is therefore actively participating in local safety issue and crisis management in collaboration with the Headquarter. Reviews the PV components of all domestic study protocols and informed consents and ensures that these parts are compliant with the PV standards and the protocol template. Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. Digital Activities, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in all interactions with patients Represents Bayer s PV system on a local level and for the countries in his/her jurisdiction and keeps the PVRC and global PV organization aware of relevant changes in the local context. Being accountable for all PV matter toward the local HA and the local organization. Being responsible to escalate any safety relevant matters and take respective actions to safeguards appropriately use and the benefit risk balance of Bayer s products on a local level. Review of local relevant medical literature according with the PV standard operations and procedures. Regular review and analysis of local regulatory context. Assists in the maintenance of company s compliance with respect to laws, regulations and guidance associated with the licensure of Bayer medicinal products with respect to patient safety and assures the correct implementation and observation of all safety related Quality System Documents (QSD). Education and training within the local organization;documentation of topics addressed during the training and of participants in the training. Assures the collection, review, processing and distribution of adverse event information on a country level regarding the Bayer products in all therapeutic areas; guides submission of Individual Case Safety Reports to the local Health Authorities of the India, Nepal, Bangladesh, Bhutan and Sri Lanka according to the local regulations. WHO YOU ARE: Advanced life sciences degree, preferably medical doctor, or equal through experience A minimum of 3-5 years of experience in a (global) healthcare organization, esp. Clinical Development and/or Medical Affairs and/or Pharmacovigilance. Strong organizational and process management skills. Strong financial reporting experience and skills and understanding of business systems. Demonstrated project management capability. Preferably in-depth experience in drug development process over different stages, esp. clinical development and clinical operations. Highly effective communicator with strong influencing ability and communication skills. Demonstrated ability to function effectively and successfully in a complex global and multicultural environment. Ability to take personal responsibility and accountability Experience of leading and contributing to teams across cultures and geographies (if applicable). Experience in development and authorship of complex PV documents Experience of working across and building effective working relationships between functions. Organized, able to multi-task effectively. Fluency in English (written and verbal communication skills). Collaborative, team-oriented, flexible. Knowledge in Pharmacovigilance relevant regulations. Ever feel burnt out by bureaucracy? Us too. Thats why were changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https: / / www.bayer.com / enfstrategyfstrateg Please don t rely upon any unsolicited email from email addresses not ending with domain name bayer.com or job advertisements referring you to an email address that does not end with bayer.com . Location: India : Maharashtra : Thane Division: Pharmaceuticals Reference Code: 839967

Lead the development and implementation of solutions to global technical services issues and concerns regarding EDC tools like Medidata RAVE or Oracle Inform or Data/Report programming or Visual Analytics tools like Spotfire or Tableau. Develop/validate Custom/Complex SAS / SDTM datasets and efficiently handle external data and reconciliations. Perform any postproduction changes to the EDC database or enhancements to the SAS programs like SAS edit checks, listings, Protocol Deviations, SAS Datasets etc, Conduct Peer Review/Quality control of study design for assigned projects. Summary of Responsibilities: Lead the development and implementation of solutions to global technical services issues and concerns regarding SAS or Python or Data/Report programming or Visual Analytics tools like Spotfire or Tableau. Develop/validate Custom/Complex SAS / Python/SDTM datasets and efficiently handle external data and reconciliations. Perform any post production changes to the SAS/Python programs edit checks, listings, Protocol Deviations, Datasets etc, Conduct Peer Review/Quality control of study design for assigned projects. Lead the development and implementation of Clinical solutions to global technical services issues and concerns regarding SAS programming. Lead the development of visual analytics dashboard using tools like Spotfire/Tableau. Complete assigned work utilising SAS, Python, SAAMA or other proprietary software according to Fortrea SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practices. Perform any post-production changes to the enhancements for SAS programs like SAS edit checks, listings, Protocol Deviations, etc, With assistance, meet with Data Manager on assigned projects to discuss contractual obligations and timelines. Act as Subject Matter Expert (SME) and be point of contact for any technical services, issues related to SAS programming. Serve as Lead Statistical Programmer providing programming support for development and maintenance of SDTM/Client standards datasets. Develop/validate Custom/Complex SDTM domains and efficiently handle external data and data reconciliations. Develop and implement SDTM automation/standardization and best programming practices across projects to enhance quality and productivity. Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, meeting timelines, maximizing quality, interaction with other departments and the client, etc Exhibit good imparting, analytical skills along with testing, troubleshooting, error fixing, and documentation skills. Participate in the ongoing review of the processes used to ensure adaptation of best practices. Conduct Peer Review/Quality control of study design for assigned projects. Able to work independently and take initiative to accept new challenges in Clinical Programming Applications, also participate in the validation of new or updates to software. Resource forecasting and allocate activities to the team members on the project. Generate reports/metrics or demonstrate programming process to sponsors/auditors (if required), assist with the design of study documents. Perform other duties as assigned by Manager. Qualifications (Minimum Required): University / college degree (life sciences, health sciences, information technology or related subjects preferred). Experience and/or education plus relevant work experience, equating to a bachelors degree will be accepted in lieu of a bachelors degree. Fluent in English, both written and verbal. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): 5 to 8 years of relevant work experience to include data management and database support or SAS Programming or Spotfire or Tableau development. Good problem-solving skills and a proactive approach. Good oral and written communication skills. Basic knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferred. Demonstrated ability to work in a team environment. Demonstrated ability to work independently under supervision. Proven interpersonal skills. Physical Demands/Work Environment: Office work environment

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. JOB RESPONSIBILITIES Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): o Assesses site processes o Conducts Source Document Review of appropriate site source documents and medical records o Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture o Verifies site compliance with electronic data capture requirements May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. Understands project scope, budgets, and timelines for own and others activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include: o Site support throughout the study lifecycle from site identification through close out o Knowledge of local requirements for real world late phase study designs o Chart abstraction activities and data collection o As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff o Identify and communicate out of scope activities to Lead CRA/Project Manager o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations o Identify operational efficiencies and process improvements o Develop country level informed consent forms o Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared o Participate in bid defense meetings Qualifications QUALIFICATION REQUIREMENTS Bachelor s degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected. Ability to manage required travel of up to 75% on a regular basis

MAIN PURPOSE OF ROLE Responsible for all business development activities . Perform projects of complex scope . MAIN RESPONSIBILITIES Involved in developing new processes to meet project needs , and for designing projects to suit the financial , operating , legal , regulatory and operating criteria elements of a project . Serve as a technical expert in economic modeling and discounted cash flow analysis . Demonstrate in-depth technical knowledge on all aspects of financial analysis and a good understanding of financial , tax , and legal issues . Utilize independent judgment within general practices and policies in selecting methods and techniques for creating solutions . Maintain in-depth knowledge of principles and concepts . Direct and coach lower level professionals . QUALIFICATIONS Education Associates Degree ( 13 years) Experience/Background Minimum 4 years

Title: PV Scientist - Senior ExpertLocation: Bangalore Purpose of the Role: We are seeking a highly motivated and skilled Pharmacovigilance Scientist to collaborate with global safety leads and program safety leads This role is essential for providing integrated medical safety strategies for assigned investigational and core (high-risk) marketed products, including input into safety aspects of clinical development, risk management, and benefit-risk management Your roleSignal Detection and Management:Perform safety monitoring using dedicated tools (eg, Spotfire, EVDAS, Empirica Signals) for signal detection Review and analyze clinical and safety database outputs; interpret aggregate safety data from clinical trials and post-marketing sources Review scientific literature for safety surveillance and signal detection Support the analyses of safety signals, contribute to authoring signal evaluation reports, and participate in relevant safety governance meetings Support communication of findings from Emerging Safety Issue Reports to external stakeholders RMP Updates and Periodic Safety Reports:Retrieve/summarize data from various sources in support of authoring and providing content for Risk Management Plans (RMPs) and periodic safety reports Support local adaptation of RMPs and respond to health authority questions Submissions and Safety Variations:Contribute to delivery of safety relevant documents of the Common Technical Document (CTD) Contribute to ISS/SCS IAP, health authority briefing documents, and product information and clinical overview addendum Clinical Trial Activities: Provide input into safety sections of the Investigational Medicinal Product Dossier (IMPD), Investigators Brochure (IB), and Informed Consent Form (ICF) Support delivery of safety-related input for clinical trial documents, including protocols and reports Provide safety related input for data monitoring committees with safety-related documentation Other Activities:Respond to queries from auditors/inspectors and participate in interviews Contribute to the design and implementation of post-authorization safety studies Develop and maintain MedDRA CMQs for signal analysis and aggregate safety data Create product-specific training for internal and external stakeholders Provide expert input into process standardization and improvement within GPS and GD Who you are: Experience Required:MD, or PhD/advanced science degree or tertiary level qualifications in a biomedical/health related field Fluent in written and spoken English Qualification:Over 4 years of Pharmaceutical industry experience or similar (egHealth Authority) Experience in Pharmacovigilance risk management in both clinical development and post-marketing areas, including submission experience Ability to work collaboratively in a global team environmentTech savy with strong analytical and communication skills

To support Global Pharma Franchise (Immuno-Inflammation\Derma\CVM) Commercial strategy team for various requirements of Competitive Intelligence Have good understanding of Pharmaceutical business from commercial and clinical development perspective; knowledge of global pharmaceutical environment and challenges enabling to provide CI support for early, near to launch and launched medicines Hand-on experience on secondary data sources and propriety databases such as PharmaProjects, TrialTrove, Cortellis, PharmaTell, Decision Resources, etc To manage multiple CI projects under tight timelines interfacing with global clientele and prioritize requests based on the criticality and business need as agreed with the stakeholders Gain business context about the internal assets, competitor dynamics and monitor competitor activity for a range of KITs/KIQs specific to the medicine/TA Deliver in depth, comprehensive, regular CI reports and support ad hoc queries in the areas of indication based pipeline landscapes, Competitor Company/ asset profile, competitor launch timelines and key event timelines, newsletters etc To engage with various internal and external stakeholders such as Forecasting/Market intelligence/Pricing & Market access/ Market research / Medical teams and able to stick the various intelligence and report the same Responsible for continuous process improvement in developing content for various CI deliverables across indications/therapy areas Interact as a partner with onshore stakeholders, not waiting to be asked to give an opinion and pushing back with respect to scenarios, iterations, analysis, and recommendations Demonstrate excellence as an individual contributor with minimal support from peers/team lead, together with the ability to mentor a team of CI offshore analysts, driving high productivity/ efficiency, and creating appropriate performance reviews and capability development plans Strong written and oral communication/presentation skills

Job description Bangalore, India Job category Clinical Development Job Title : Competency Development Professional Department: Global Patient Safety,GBS Job Level :6 Are you passionate about developing and implementing innovative learning methodologiesDo you want to play a key role in enhancing the onboarding and training experience for employees in Global Patient Safety, BangaloreDo you have the interpersonal Skills to navigate in a complex stakeholder landscape and are you able to set direction and deliver resultsIf so, we want you to join our team as a Competence Development Professional. Read more and apply today for a life-changing career. The position: As a Competency Development Professional at Novo Nordisk, you will support the implementation and operation of the competency framework and the continuous learning design model. Work both independently and in collaboration with a team of highly skilled, committed, and enthusiastic colleagues across the functional areas in Global Patient Safety , Bangalore(GPS BLR) and across Novo Nordisk Organize and align onboarding programs across GPS, Bangalore. Support the training of employees. Define and implement relevant learning methodologies and supporting technologies to enhance the learner experience and output. Drive initiatives for innovative, fit-for-purpose process optimization and training. Assume responsibility, communicate information, and take action as essential parts of your workday. Qualifications: Should possess a bachelor s/master s degree in pharmacy /Lifesciences A minimum 6 years of Pharmacovigilance experience is desired. It is preferable to have exposure to training and co ordination activities within the domain Relevant experience and solid understanding of processes and regulatory requirements within pharmacovigilance A strong insight into the value chain within a pharma company Proven track record in establishing effective learning and development governance and working closely with stakeholders to ensure it creates value The ability to work independently in a continuously developing environment. Strong communication and interpersonal skills. Ability to thrive working across skill areas and cultures in a global organization. Demonstrate critical thinking and creative problem-solving abilities in addressing challenges. Design and implement comprehensive training programs for new employees to ensure smooth onboarding process About the department : Global Patient Safety Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed products and is responsible for global handling and reporting of adverse event reports. Working at Novo Nordisk At Novo Nordisk, we don t wait for change. We drive it. We re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales we re all working to move the needle on patient care. Contact To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Deadline: Apply before 28th February 25 Disclaimer It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Related jobs