652 Clinical Trials Jobs - Page 22

Role & responsibilities '' Immediate Joiners Preferred '' Role : Senior Statistical Programmer Location : Hyderabad Experience : Minimum 7 years as Clinical Statistical Programmer We are looking for Senior Statistical Programmer who is responsible for designing, developing, and implementing complex statistical programming solutions to support clinical trial data analysis. This role involves collaboration with cross-functional teams, including Biostatistics, Clinical Data Management, and Regulatory Affairs, to ensure high-quality and timely data deliverables. The Senior Statistical Programmer is expected to handle programming activities for clinical studies and may provide guidance to junior programmers. Key Responsibilities Act as programming lead on Phase I-IV group of studies. Leading the studies and acting as the POC for multiple studies. Perform programming activities for a trail indication. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with SDTM Implementation Guide, project standards, and the study protocol. Perform CDISC activities in accordance with corporate quality standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other regulatory requirements. Develop/Validate SAS analysis datasets (ADaM) and prepare tables, listings, and figures as per specifications, SAP and Mockshell. Creates programs to prepare graphs and tables that are required in clinical study reports, safety reports, efficacy reports, etc., ensuring on-time quality delivery. Perform CRF annotation and Specification creation as per CDISC standards. Validate tables, listings, and figures as per client required Mockshells. Supporting database QC activities. Support client and internal audits. Validate and transform datasets as per client specifications. Validate tables, listings, and figures as per client required specifications. Ability to work on data migration from legacy datasets to standards such as CDISC and client specific requirements. Communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs. Co-ordinate with the client regarding data issues, outliers, reviews, etc. Provide CDISC training, guidance, and project leadership to team members. Education & Qualification M.Sc. Statistics, Bachelors/Masters degree in Life Sciences, B. Tech (Any stream) and B. Pharmacy/M. Pharmacy Skills Strong written and oral communication skills and time management skills Ability to effectively prioritize and execute tasks in a high-pressure environment. Ability to work independently, take initiative and complete tasks to deadlines. Ability to work in a team-oriented, collaborative environment. Ability to work positively within a continually changing environment. To be determined in achieving goals Ability to manage multiple projects under tight timelines Knowledge & Experience Strong knowledge of global clinical trial practices, procedures, development process, and clinical trial data flow Knowledge in TLF’s Knowledge in Data Analysis using SAS Knowledge in Generating DEFINE.XML and Reviewers Guides for regulatory submissions. Preferred candidate profile

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

Job responsibilities • Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. • Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. • Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. • Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports • Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. • Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. • Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. • Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. • Performs system integration activities, application updates, and user acceptance testing. • Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. • Assists in project meetings and actively contributes and participates in departmental review meetings. • Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. • Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. • Manages project resources, proactively alerting management of delivery and resourcing needs. • Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. Qualifications What were looking for • Bachelor’s degree preferred, or equivalent combination of related education and experience. • 5 years of experience, must have Data visualization experience in Spotfire/Tableau/PowerBI (Useful) • Experience with either Python/SAS/SQL. • Clinical background experience is a must, with preferred experience in iMedidata Rave & Veeva EDC. • Good to have Spotfire API experience/knowledge. • The ability to deal effectively with sponsors and internal customers at all levels. • Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. • Demonstrated experience in managing multiple priorities in a highly dynamic environment • Experience working in a matrix-structured environment is preferred • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail • Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. • Ability to travel as necessary (up to 25%)

Oversee, lead & manage cross-functional team & external service providers. Accountable for conduct of clinical trials & functioning of the Clinical Operations dept. Ensure all projects are reviewed periodically & completed as per agreed timelines. Required Candidate profile Regular interactions with internal teams and Sponsors

Job Title: Senior Biostatistician Location: Bengaluru, KA Link to Apply: https://e.lilly/3DZ4ljx Purpose: The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies. Key Responsibilities: The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs. Statistical Trial Design and Analysis Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study. Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created. Collaborate with data management in the planning and implementation of data quality assurance plans. Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected. Participate in peer-review work products from other statistical colleagues. Communication of Results and Inferences Collaborate with team members to write reports and communicate results. Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings. Respond to regulatory queries and to interact with regulators. Therapeutic Area Knowledge Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor. Regulatory Compliance Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training. Minimum Qualification Requirements: M.S. or Ph.D. in Statistics or Biostatistics or equivalent with more than 3 Years of relevant experience Other Information/Additional Preferences: Statistics, Biostatistics, or equivalent of field study Proficient in the SAS programming language Interpersonal communication skills for effective customer consultation Teamwork and leadership skills Technical growth and application with working knowledge of experimental design and statistics Self-management skills with a focus on results for timely and accurate completion of competing deliverables Resource management skills Creativity and innovation Demonstrated problem solving ability and strategic thinking Business process expertise associated with critical activities (e.g. regulatory submissions) Regards Manvendra Singh Manager - Talent Acquisition Eli Lilly & Company Bangalore, KA

Job Description: We are looking for a vibrant and astute cross disciplinary professional (e.g MBBS + MMST or equivalent program) who is eager to make a real difference, strong clinical knowledge, the will to learn, the acumen to research, the skills to manage, and the ability to lead. Not to mention empathy, patience and meticulousness to understand clinical needs precisely, communicate them appropriately to a multidisciplinary team and engage effectively with clinical and technical leaders alike to play the role of an effective coordinator to develop winning medical devices for a global audience . Key Responsibilities: Be an internal clinical resource: Collect, assimilate, organize and internally share relevant clinical information and evidence from scientific publications, conferences, customer engagement and from online sources, thus becoming a go-to internal resource for medical, clinical and scientific domain knowledge in Orthopaedics. Draft clinically relevant product specifications: Help build relevant product specifications for medical devices that can succeed in global and Indian markets by addressing real unmet needs. Be a coordinator for the R&D team, keeping them clinically tuned: Constantly engage with and coordinate with the Research and Development team, ensuring that products being developed reliably fulfil patient needs, this includes ongoing verification and validation activities from a clinical lens. Clinical trials support: Participate in the entire life-cycle of clinical trial related activities starting with site-scouting, site engagement, site coordination, gathering data from sites, analysis of clinical trials data and manuscript writing based on the same. (primarily office work). Training coordination: Participate in training related clinician engagement exercises spanning newsletters, webinars, online courses including content preparation, management, and real-time coordination of learning activities.(in-office + onsite work). Clinician engagement: Engage meaningfully and credibly with specific key clinicians, and get them on board as needed. (Note: this is not a sales or business development position. Key Requirements : Education: MBBS, followed by MMST or other degree in engineering / research Other. Skills: Ability to coordinate seamlessly with professionals from diverse backgrounds, and keep track of overall project progress. Fast assimilation of knowledge as needed by the context. An ability to rapidly master the use of various software platforms for learning management (online courses and webinars). Expert level proficiency in making crisp, elegant MS PowerPoint presentations. Confident communication with stakeholders from various geographies. Flexibility, adaptability and responsiveness to organizational needs within the broad framework of the role. Salient features of this opportunity : This role offers a rare opportunity to be part of such a unique mission to disrupt an age-old industry and to alleviate pain and suffering for thousands of patients internationally. We are a patient centred company with a people first culture. We offer competitive remuneration. Be part of one of the state s largest medical device R&D facilities that we are building. A collaborative and inclusive work environment with plenty of opportunities to learn and grow. The chance to make a meaningful impact on healthcare and patient outcomes.

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Summary: The Real-World Data (RWD) Analyst will play a critical role within BIA Hyderabad. This specialized position focuses on analyzing and deriving insights from real-world data sources to generate evidence and support decision-making across the organization. The RWD Analyst will leverage a variety of RWD and evidence analytics techniques to contribute to research, clinical development, market access, and post-marketing activities. Roles & Responsibilities :- Collaborate with cross-functional teams, including researchers, clinicians, market access and regulatory stakeholders, to understand data needs and objectives for RWD analysis Identify relevant real-world data from various sources, such as electronic health records (EHRs), claims databases, registries and other healthcare databases Clean, transform and preprocess real-world data to ensure data quality, consistency and compatibility for analysis Apply appropriate statistical techniques to analyze real-world data and generate insights on research questions or business objectives Partner with senior analysts to conduct observational studies, comparative effectiveness research (CER), patient outcomes research and other types of RWD analysis to evaluate treatment outcomes, safety profiles and healthcare utilization patterns Partner with senior analysts to develop and implement data analysis plans, including study designs, statistical methodologies and modelling approaches Interpret and communicate findings from RWD analysis through reports, presentations and visualizations to stakeholders Partner with senior analysts to collaborate with internal and external teams to design RWD studies, including protocol development, data collection and analysis Stay updated and compliant with the regulatory landscape related to real-world data analysis Contribute to the development and implementation of RWD strategies and best practices within the organization Skills and competencies : Strong understanding of real-world data sources, such as electronic health records, claims databases, registries and other healthcare databases Proficiency in data pre-processing, cleaning and transformation techniques to ensure data quality and compatibility for analysis Knowledge of relevant statistical methodologies, including propensity score matching, survival analysis and regression models, for real-world data analysis Solid problem-solving skills and the ability to derive meaningful insights from complex real-world data sets Solid communication and presentation skills to effectively convey complex concepts and findings Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously Strong attention to detail and accuracy in data analysis and interpretation Experience:- A Bachelors or Masters degree (preferred) in a relevant field, such as Biostatistics, Epidemiology, Health Informatics or a related discipline Minimum 2-3 years experiencedemonstrated in real-world data analysis, preferably within the biopharma or healthcare industry Experience applying statistical and analytical techniques, such as observational study design, CER, patient outcomes research, and data modelling, to analyze real-world data Proficiency in R or SAS and SQL required Working knowledge of data visualizationtools, such as Tableau or Power BI, is desirable Working knowledge and familiarity with relevant statistical methodologies and study designs used in real-world data analysis Experience or familiarity with the biopharma industry or healthcare domains is preferred With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Recruiter to add With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Job Title/Role : Sr. Support Manager, Interactive Response Technology Department Name/Functional Area : Global Clinical Supply Chain > Clinical Supply Chain Technologies > IRT Location : Office based . Position Summary This position supports multiple IRT studies (system development, study management, change management, audits and data provisioning). Supports UAT Services organization as required. Identifies areas of process improvement and participates or leads these initiatives. Duties/Responsibilities Lead successful maintenance support and projects to ensure execution and on time delivery of Interactive Response Technology (IRT) changes, data and support integrations with other clinical systems (e.g., Depots, Central Lab, and EDC), such that the resultant IRTs are fit-for-purpose as defined by protocol and study operational parameters with special emphasis on adherence to BMS standards and quality principles. Works independently and assume support role responsibilities on assigned projects. Collaborate with the IRT Team where necessary to ensure BMS standards and/or for requests by study teams that are not within these standards or best practice are addressed. Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team. During IRT maintenance act as the primary contact for assigned studies for the cross-functional study team and vendor. Additionally, provide timely response to all randomization/IRT issues (including data integrations and delivery) that arise during IRT lifecycle and ensure they are resolved. Maintain vendor performance quality events in ADI log. Act as off hours audit/inspection support contact as needed to support rest of world. Responsible for generation and oversight of patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements. Distribute patient randomization and container schedules as appropriate to Clinical Supply P&L and IRT vendors. Manage special project implementation by identifying project needs, tracking, implementation, and reporting to a central project team. Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team. Support IRT improvement initiatives and manages improvement projects that impact daily operations to improve efficiency. Support key department and enterprise level initiatives as part of the IRT representative. Ensure on time delivery of maintenance support and may be involved in user acceptance testing of IRT systems per BMS SOPs and procedures, write or review User Acceptance Test Plan and causes to ensure thorough testing of high -risked areas and new functionality documented in the user requirements. Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance BMS SOPs and processes. Ensure effective system access and functionality across all countries and all user locations. Complete all assigned training by due date Support unblinding activities as needed. Ensure on time development of IRT data transfers with vendors and/or third-party vendors. Ensure eTMF compliance at the study level in accordance with group and BMS guidance. Engage and support study and CSMT project teams as deemed necessary. Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms. Additional tasks within scope of expertise and experience as assigned by the supervisor in pursuit of BMS goals. Reporting Relationship This position reports to the Associate Director, Interactive Response Technology (IRT). Qualifications Minimum bachelor s degree Minimum of 3 to 5 years work experience preferably in a health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.) Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint. Clinical Research experience Working knowledge of IRT Working knowledge of Clinical Trial Management Systems Working knowledge of clinical supplies Able to think outside of the box, have excellent communication and analytical skills to successfully deliver optimal IRT solutions across a diverse and dynamic portfolio. Understand the nature of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards. Exposure to working in a GMP / GCP environment and with regulatory audit teams. Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required Comfortable working with a global team, partners and customers in a change agile environment MS Project, MS Visio, or any other requirements visualization and analysis tools) With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Dear Applicant, We have excellent opportunities for freshers & experienced of " Neurologist " in Various Super & Multi Specialty Hospital and Diagnostic Center of Various with good Package & Accommodation + Incentive. JOB DESCRIPTION:- Designation: Neurologist Qualification: MD/DM/DNB Current package: Upto - (77 LPA) Experience: 1-5 Year's Key Skills: Truma, Spinal, Nerves System, Neurosurgical, Diagnosis , Treatment Planning , Treatment , Clinical Trials , Palliative Care , Patient Education and Counseling, ICU, OPD, Postoperative Care Location: Assam - Amingaon Chhattisgarh - Raipur Madhya Pradesh - Sagar Rajasthan - Bhilwara Uttar Pradesh - Jaunpur Please contact for further discussion. Also kindly share your updated resume mention your preferred location & current CTC on Mail Id: jobs@angplacement.in We do not charge any consultancy charges from candidates. Thanks & Regards, Jagdish Teli Managing Director 9993872666/ 7000476894 ANG Placement & Staffing Solutions Pvt. Ltd.

Role and Responsibilities:As a Senior Research Analyst (Secondary Research) at MakroCare, your role will involve performing comprehensive secondary research to provide detailed information and complete profiles of products You will be responsible for capturing data on companies developing drugs, devices, and other pharmaceutical products from various sources such as press releases, annual reports, clinical trial reports, and more Your primary Responsibilities will include:Grasping new concepts quickly and evaluating scientific data Literature - review, Drug, Medical Devices, Regulatory search and ClinicalTrials review & secondary searchKeeping up-to-date with changes in regulatory legislation and guidelines Conducting intelligence research and analysis on public, biotech, and pharma companies Compiling and analyzing data using modern and traditional methodsEvaluating applicable laws and regulations to determine impactMentoring team members in data research and analysis Candidate Qualifications:To be eligible for this role, you should meet the following criteria:4-6 years of experience in (Drug, Clinical Trials & Med Devices) - Literature, Regulatory, Clinical Trials data research and data analysis Education in any UG/PG in Life SciencesGood knowledge and skills in Scientific terminology, Secondary research and Regulatory Authorities (likely Drug, Clinical Trials & Medical Devices) Required Skills:This role requires the following skills:Drug, Regulatory Secondary Data Research and Clinical Trials Secondary Data Research Good knowledge of all aspects of product development, including research, Drugs, Medical devices, Regulatory Affairs, Clinical trials, manufacturing practices, regulations, and approval processesLiterature Search and Secondary Research skills Knowledge of drugs, Medical Devices and clinical trials Location - Madhapur, Hyderabad, Telangana, India

Company Description AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Medical Science Liason Develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support to Abbvie initiatives in assigned therapeutic areas. Executes against the Medical Affairs plan for India. Provides scientific education and training initiatives across Abbvie Oncology portfolio. Plans and leads scientific communication with key therapy leaders and stakeholders, organizing advisory board meetings, facilitating clinical trials, and serving as the medical resource for both external and internal stakeholders. This position is a non-promotional role. The primary focus is providing Healthcare Professionals with fair and balanced scientific information. Facilitates information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized by Abbvie. Works closely with other Abbvie personnel to ensure information, education, and research needs of healthcare professionals are met and to ensure scientific and technical training needs of commercial organizations are identified and met. Key Responsibilities Area As an internal medical / technical / scientific resource, leads medical affairs objectives in the affiliate country. The role requires competency in practical aspects of patient care, and the ability to use medical and scientific information to facilitate engagement of physicians and others in the clinical and basic scientific issues relevant to Abbvie s products. Responsible for maintaining annual expenses within assigned budget parameters. Responsible for accurate and timely documentation of medical lead activities. The employee must conduct their work activities in compliance with all Abbvie internal requirements and with all applicable regulatory requirements. Abbvie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. Identify, develop and maintain professional relationships with thought leaders, academic centers and researchers in assigned areas of therapeutic interest to ensure access to current medical and scientific information on Abbvie products. Work closely with the Commercial leaders for business planning , Therapeutic leads & Dir, Medical Affairs to set priorities, and activities. Upon request, present data on Abbvie products to healthcare professionals including physicians, academic institutions, researchers, and other health care professionals. Support research initiatives as requested by Abbvie R&D, Clinical Operations, and Medical Affairs Departments. Serve as internal medical and scientific resource to assigned Abbvie therapeutic areas for development of disease-state and product communications and materials that are medically accurate, balanced, and consistent with regulatory guidelines. Support Round Table and Advisory Board sessions to ensure accuracy of scientific and clinical data. Conducts on-going training to medical affairs, field sales and other internal personnel as required. A high level of travel / field time is to be expected within this position (approximately 60% of time spent outside the office). This role will also serve as the local representative of the Global Medical Office associated functions. (eg PV, HEOR etc) Qualifications Qualifications Requirements Minimum 2-3 years post-qualification work experience in Medical affairs function. Experience working within the pharmaceutical industry or within clinical research is preferred Experience of working collaboratively and cross-functionally in a matrix structure, supporting multiple stakeholders Demonstrated ability to learn quickly and convey clinical and non-clinical technical information effectively to individuals with varying degrees of scientific acumen. Demonstrated strong presentation and teaching skills with ability to effectively share information with others Demonstrated ability to develop and maintain strong relationships; to lead & engage Experience applying analytical skills, to critically evaluate and effectively communicate key clinical data Experience working with technology, including systems such as Microsoft Office.

About The Role We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology. We are seeking a strong leader who can confidently influence stakeholders and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Study build and Edit check development Programming Languages ? Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? with experience range of 9-13 years Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related discipline ? Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Manager, CSAR - SAS Edit Check Programmer What you will do Let’s do this. Let’s change the world. The Manager, CSAR - SAS Edit Check Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Edit check programming activities. The Manager, CSAR - SAS Edit Check Programmer will create and implement edit checks, adhering to Amgen standards, procedures, and best practices using SAS programming. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Edit Check Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Proficient in SAS edit check programming Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies What we expect of you We are all different, yet we all use our unique contributions to serve patients. Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related field with6 to 8years of experience. Master’s degree and 4 to 6 years of experience. Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) 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.

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Required Skills: Experience understanding and interpreting data/information and its practical application Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through Ability to follow controlled processes Excellent spoken and written English Project management skills, including ability to prioritize work in order to meet required deadlines Problem solving ability Basic Qualifications: Degree with 2-5 years of experience working with regulatory documents in a biotech/ pharmaceutical environment Familiarity with clinical research and clinical regulatory documents Knowledge of clinical trial disclosure regulations, guidelines, and best practices ? EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with 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 an accommodation.

Manager - International Regulatory Lead Role NameManager – International Regulatory Lead (IRL) Department NameInternational Regulatory Team, Global Regulatory Affairs Role GCF5A ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to - optimize product development and regulatory approvals in International countries - develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with 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 an accommodation.

Associate IS Bus Sys Analyst What you will do Let’s do this. Let’s change the world. In this vital role you will leverages domain, technical and business process expertise to provide exceptional end user support of Amgen’s external suppliers to ensure their effectiveness to deliver Amgen clinical trials for Amgen study teams. This role involves working closely with internal and external business stakeholder and support analysts to ensure rapid resolution of technical issues, performing route cause analysis and implementation of long-term preventative solutions. You will collaborate with the Product Owner and a team of other Business Analysts to ensure operational support excellence from the team. Roles & Responsibilities: Build strong relationship with key business leads and external partners to ensure their needs are being met Oversee expedited resolution of business-critical issues affecting the delivery of key external business partners Work with Product owner and business stakeholders to collected details requirements and user stories Analyze technical and process problems and work with multi-functional owners to develop solutions Maintain accurate documentation of configurations, processes, and changes Maintain detailed system and user documentation What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications. Basic Qualifications: Bachelor’s degree and 0 to 3 years of Life Science/Biotechnology/Information Systems experience OR Diploma and 4 to 7 years of Life Science/Biotechnology/Information Systems experience Preferred Qualifications: Must-Have Skills: Customer focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on technology topics Experience of working with or supporting systems used to execute clinical trials. E.g. Rave, CTMS, Veeva Excellent problem-solving skills and a committed attention to detail in finding solutions Good-to-Have Skills: Experience of working with or in a Clinical Research Organizations (CROs) or other specialist suppliers supporting clinical trials Experience with Agile software development methodologies (Scrum) Knowledge of network security protocols and tools (e.g., IPSEC, SSL, IDS/IPS, firewalls) Experience of O365 Cloud PC VDI Professional Certifications : SAFe for Teams certification (preferred) Soft Skills: Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Familiarity with GxP, CFR 21 Part 11 and systems validation Ambitious to further develop their skills and career 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.

Skill required: Life Sciences (AR&D) Services - SDTM Programming Designation: Business Advisory New Associate Qualifications: BE/BTech/Bachelor of Information systems and Management Years of Experience: 0 to 1 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.sdtm programmerProgram mapping of eCRF and external data into SDTM standards using SAS/ETL tools as applicable. What are we looking for? sdtm programmersdtm programmer Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,Bachelor of Information systems and Management

We are seeking a motivated and detail-oriented Clinical Research Associate (Fresher) to join our clinical research team. You will assist in the planning, monitoring, and documentation of clinical trials while ensuring compliance with regulatory guidelines and study protocols. Key Responsibilities: Assist in the coordination and monitoring of clinical trials across various sites. Ensure accurate collection, documentation, and reporting of clinical data. Support investigators and site staff with study protocols and procedures. Verify compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. Help in preparing study-related documents and reports. Participate in site visits, audits, and data review activities. Assist in conducting clinical trials and analyzing research data.

We are seeking a motivated and detail-oriented Clinical Research Associate (Fresher) to join our clinical research team. You will assist in the planning, monitoring, and documentation of clinical trials while ensuring compliance with regulatory guidelines and study protocols. Key Responsibilities: Assist in the coordination and monitoring of clinical trials across various sites. Ensure accurate collection, documentation, and reporting of clinical data. Support investigators and site staff with study protocols and procedures. Verify compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. Help in preparing study-related documents and reports. Participate in site visits, audits, and data review activities. Assist in conducting clinical trials and analyzing research data.

We are seeking a motivated and detail-oriented Clinical Research Associate (Fresher) to join our clinical research team. You will assist in the planning, monitoring, and documentation of clinical trials while ensuring compliance with regulatory guidelines and study protocols. Key Responsibilities: Assist in the coordination and monitoring of clinical trials across various sites. Ensure accurate collection, documentation, and reporting of clinical data. Support investigators and site staff with study protocols and procedures. Verify compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. Help in preparing study-related documents and reports. Participate in site visits, audits, and data review activities. Assist in conducting clinical trials and analyzing research data.

We are seeking a motivated and detail-oriented Clinical Research Associate (Fresher) to join our clinical research team. You will assist in the planning, monitoring, and documentation of clinical trials while ensuring compliance with regulatory guidelines and study protocols. Key Responsibilities: Assist in the coordination and monitoring of clinical trials across various sites. Ensure accurate collection, documentation, and reporting of clinical data. Support investigators and site staff with study protocols and procedures. Verify compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. Help in preparing study-related documents and reports. Participate in site visits, audits, and data review activities. Assist in conducting clinical trials and analyzing research data.

We are seeking a motivated and detail-oriented Clinical Research Associate (Fresher) to join our clinical research team. You will assist in the planning, monitoring, and documentation of clinical trials while ensuring compliance with regulatory guidelines and study protocols. Key Responsibilities: Assist in the coordination and monitoring of clinical trials across various sites. Ensure accurate collection, documentation, and reporting of clinical data. Support investigators and site staff with study protocols and procedures. Verify compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. Help in preparing study-related documents and reports. Participate in site visits, audits, and data review activities. Assist in conducting clinical trials and analyzing research data.

We are seeking a motivated and detail-oriented Clinical Research Associate (Fresher) to join our clinical research team. You will assist in the planning, monitoring, and documentation of clinical trials while ensuring compliance with regulatory guidelines and study protocols. Key Responsibilities: Assist in the coordination and monitoring of clinical trials across various sites. Ensure accurate collection, documentation, and reporting of clinical data. Support investigators and site staff with study protocols and procedures. Verify compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. Help in preparing study-related documents and reports. Participate in site visits, audits, and data review activities. Assist in conducting clinical trials and analyzing research data.

We are seeking a motivated and detail-oriented Clinical Research Associate (Fresher) to join our clinical research team. You will assist in the planning, monitoring, and documentation of clinical trials while ensuring compliance with regulatory guidelines and study protocols. Key Responsibilities: Assist in the coordination and monitoring of clinical trials across various sites. Ensure accurate collection, documentation, and reporting of clinical data. Support investigators and site staff with study protocols and procedures. Verify compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. Help in preparing study-related documents and reports. Participate in site visits, audits, and data review activities. Assist in conducting clinical trials and analyzing research data.