1290 Clinical Trials Jobs

You are a highly skilled Senior SAS Programmer sought to support statistical programming activities for clinical trials. Your responsibilities include end-to-end SAS programming for analysis and reporting, ensuring regulatory compliance, data standards, and high-quality deliverables. Your expertise in efficacy analysis, SDTM and ADaM generation, and TLF programming is crucial for this role. You will manipulate, analyze, and report clinical trial data using SAS, generating and validating SDTM and ADaM datasets in adherence to CDISC standards. Additionally, you will create and validate Tables, Listings, and Figures (TLFs) for study reports and regulatory submissions. Your role involves developing complex ad-hoc reports from raw clinical data and applying a deep understanding of efficacy analyses and clinical endpoints. Contribution to the preparation and review of submission documents and eCRTs is expected, as well as production programming and quality control to ensure accuracy and consistency. As a team player, you will commit to quality and meeting project deadlines, remaining adaptable and flexible in a fast-paced clinical environment. Qualifications required include a Bachelors or Masters degree in Life Sciences, Statistics, Computer Science, or a related field, along with 6+ years of hands-on experience in clinical trial programming using SAS. Proficiency in CDISC standards, Base SAS, SAS Macros, SAS/STAT, and SAS/GRAPH is essential. Experience in generating datasets and outputs for regulatory submissions and familiarity with eCTD standards are preferred. Strong attention to detail and analytical problem-solving skills are necessary for this role. Join a collaborative team environment where your expertise in clinical data programming directly contributes to advancing global healthcare. Precision, integrity, and innovation are valued in every project undertaken.,

Traya Health is an innovative health and wellness company specializing in holistic hair care solutions that combine cosmetic, ayurvedic, and pharmaceutical approaches. The mission of Traya Health is to provide effective, science-backed treatments that address the root causes of hair concerns through personalized care regimens. As the Research & Development Team Lead at Traya Health, you will play a crucial role in driving the company's product innovation strategy across cosmetic, ayurvedic, and pharmaceutical categories. This position requires a unique blend of scientific expertise, creative problem-solving, and cross-functional leadership to develop groundbreaking hair care formulations that align with the holistic treatment philosophy of Traya Health. Your key responsibilities will include leading the end-to-end development of new products, from conceptualization to market launch, ensuring alignment with consumer needs and company strategy. You will be tasked with developing and optimizing formulations for hair care products by integrating Ayurveda, Allopathy, and modern science. Ensuring regulatory compliance, overseeing clinical trials and efficacy studies, and collaborating closely with marketing, manufacturing, and quality assurance teams will also be part of your role. As the ideal candidate for this position, you should have a background in FMCG/Pharma with an understanding of Ayurveda. A PhD or Master's degree in Cosmetic Science, Pharmaceutical Sciences, Chemistry, Biology, or related field, along with a minimum of 10+ years of experience in R&D within personal care, pharmaceutical, or related industries is required. You should have a proven track record of successful product development and commercialization, experience managing cross-functional R&D teams and projects, and a strong understanding of hair biology, scalp conditions, and treatment modalities. Furthermore, your leadership skills should include exceptional critical thinking and problem-solving abilities, strong project management capabilities, outstanding communication skills, and a collaborative mindset to work effectively in a matrix organization. Experience in personalized or customized product development, clinical testing, digital tools for formulation management, natural and sustainable ingredient sourcing, and knowledge of Indian regulatory environment for personal care and pharmaceuticals would be considered desirable qualifications for this role. If you are a dynamic and experienced professional with a passion for innovation and scientific excellence in the field of hair care product development, we invite you to join Traya Health as the Head of Research & Development and contribute to our mission of providing holistic solutions for hair concerns.,

About Immuneel Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India and the world. For more details, please refer www.immuneel.com We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy. Working at Immuneel promises the excitement of an agile startup on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work-life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are: Passionate in driving patient outcomes: We are passionately committed to doing the RIGHT thing to achieve the best outcomes for our patients through innovation, agility and performance orientation. We put the impact on the patient above all else. Responsible and accountable: We demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performance. Transparent, honest, and supportive in how we work together: We insist on integrity and respect for the individual. We demand excellence. Our performance management is focused on excellence through timely and constructive feed-forward. Inclusive and flexible: We are full of life and embrace all opportunities to collaborate and work together. We are excited about the collective knowledge and expertise that we share. Being and thinking different is valued. Immuneel prides itself as an organization that is keeping pace with best practices in organization design. Our role-based organization incorporates global trends in human capital that promote focus on work and greater nimbleness. Our role-based structure allows you to be cherished by the work you do and bring value to your work rather than designations, our organization is simplified into a flat, non-hierarchical, millennial, organization where you may fully inherit the role you play in the organization and are recognized by the accountability you take and the work you deliver. Immuneels employees are integral to our quest to develop and deliver high quality engineered cell and gene therapies in India. We believe that our culture provides an environment for employees to excel and find purpose. The strength of our team is every bit as important as our cutting-edge technology and we invest in clear compensation and comprehensive benefits for our employees. People for us, are not resources, but our capital. If you are a talented professional, an out-of-box thinker with a zeal to help change, and passionate about healthcare, we invite you to join us and be a part of a historic initiative in India. Interested to be a part of the next revolution in cancer treatment Send your resume to [HIDDEN TEXT] 1. Role Title: Analyst / Specialist - Regulatory Affairs (CMC and Operations) 2. Department/Function: Regulatory Affairs 3. Reporting Structure: Reports to: Regulatory Affairs Direct Reports: Individual Contributor 4. Role Summary: The ideal candidate will play a critical role in managing and supporting regulatory submissions, ensuring compliance with global regulatory requirements, and maintaining the highest standards of operational excellence in regulatory processes. This role requires strong organizational skills, a high level of attention to detail, and the ability to collaborate across cross-functional teams. 5. Key Responsibilities: Regulatory CMC and operations Prepare, review and submit regulatory applications , including but not limited to Clinical Trial Applications, IND, MA applications, Test licence NoC, Import licence applications, IND, IMPD for cell and gene therapy products to CDSCO and respective regulatory agencies in other geographies. Prepare, review and submit regulatory applications, including but not limited to Form B1, Form C3, Form C5 to RCGM. Any other regulatory compliance documentation related to RCGM. Prepare, review and submit regulatory applications, including but not limited to Form 27 applications, Form 30 applications, WHO GMP applications, COPP applications to KDCD. Any other regulatory compliance documentation related to KDCD. Should be able to manage all IBSC/GTAEC (if required) related assignments. Prepare, review and submit response to various queries received from CDSCO/RCGM/KDCD/Other regulatory agencies. Follow up for various regulatory applications submitted to CDSCO/RCGM/KDCD/Other regulatory agencies in terms of seeking acknowledgements, queries, response to queries and approvals. Expertise in handling the online submissions on RCGM/SUGAM/NSWS portals. Very well versed with CTD/eCTD requirements for M1, M2, M3, M4 and M5 of the dossier. And ACTD requirements for Part I, Part II, Part III and Part IV of the dossier. Should have understanding about the regulatory compliance with respect to life cycle management (LCM) activities and changes made to the approved products. Engage in cross functional activities such as audit management and compliance. Government Affairs Liaison with CDSCO Zonal Office (Bengaluru, Karnataka), KDCD, RCGM office, IBSC Committee as assigned. Establish working relationship, facilitate discussions and follow up with the above regulatory bodies. Regulatory Intelligence : Stay updated on Indian as well as Global regulatory requirements and changes in regulatory guidelines for Biologics and CGT products. Stay updated in developers of CGT and the competitive intelligence of similar CGT product development in India as well as globally. Communicate changes and their implications to relevant cross functional teams to ensure regulatory compliance. 6. Competencies Required: Technical CDSCO Regulations: Deep understanding of the Drugs and Cosmetics Act, 1940, and related rules, guidelines, and circulars issued by the CDSCO. Drug Development Lifecycle: Knowledge of the entire drug development process, from preclinical research to life cycle management (LCM). Clinical Trials: Familiarity with clinical trial regulations, including Good Clinical Practices (GCP) and the New Drugs and Clinical Trials Rules, 2019. Drug Approval Process: Understanding of the procedures for obtaining marketing authorization for new drugs, including dossier preparation and submission. Pharmacovigilance: Knowledge of pharmacovigilance regulations and guidelines for reporting adverse drug reactions. Behavioural Adaptable, Team Player, Collaborative, Empathetic, (Good) Listener, Persuasive, Ethical, Resourceful, Self Motivated, Result Oriented, Organised, Persistent, Conceptual, Information Seeker, Enthusiastic, Committed, Hard Working. Soft Skills: Liaison & Negotiation: Ability to effectively communicate and negotiate with regulatory officials/partners, build rapport, and address their queries. Technical Writing: Excellent writing skills to prepare clear, concise, and accurate regulatory documents, such as applications, submissions, and responses to queries. Presentation Skills: Ability to present information effectively to internal and external stakeholders, including regulatory agencies, cross functional teams and partners. Interpersonal Skills : Strong interpersonal skills to interact with colleagues, superiors, and external stakeholders in a professional and collaborative manner. Critical Thinking: Ability to analyse complex regulatory requirements and identify potential challenges. Problem-Solving : Ability to find solutions to regulatory issues and address queries from CDSCO efficiently. Attention to Detail: Meticulous approach to ensure accuracy and completeness of regulatory documents. 8. Qualifications: Educational Qualification: Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, or a related field. Experience: 2-5 years of experience in regulatory affairs (CMC + Operations), or a related field. Extensive experience in handling regulatory applications to DCGI, RCGM, KDCD and other regulatory agencies. 9. Working Conditions: Role Type: Full Time Work Hours: 9:00 AM to 6:00 PM for the General Shift and 2:00 PM to 11:00 PM for the Post-Noon Shift (on a rotational basis). There will be two days off each week, which may not necessarily fall on a Saturday or Sunday. Travel Requirements: Occasional Base Location: Bengaluru. Office Location address - Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099 Show more Show less

The PV Scientist Manager is responsible for contributing to the planning, preparation, writing, and review of non-medical portions of aggregate reports. Collaborating with affiliates and other internal Amgen partners, the PV Scientist Manager ensures timely deliverables. Additionally, reviewing Adverse Events/Serious Adverse Events from clinical trials is part of the role. Under the guidance of the Global PV Sr. Scientist or Lead, the PV Scientist Manager reviews study protocols, statistical analysis plans, and other clinical study-related documents. They provide input on the design of safety data tables, figures, and listings from clinical studies. Participation in the development of safety-related data collection forms, attending study team meetings, and conducting signal detection, evaluation, and management are key responsibilities. The PV Scientist Manager performs data analysis to evaluate safety signals, collaborates with the Global Safety Organization (GSO) on analysis results, and prepares safety assessment reports and other safety documents. They search and review adverse event data and relevant literature for signal detection purposes, participate in Safety Governance processes, and prepare presentations on safety recommendations for decision-making bodies. Assisting in the development of risk management strategies, providing content for risk management plans, updating regional risk management plans, overseeing risk minimization activities, and preparing responses to regulatory inquiries related to risk management plans are critical tasks. Supporting activities related to new drug applications and regulatory filings, contributing to safety-related regulatory strategies, and assisting in developing safety-related regulatory activities are also part of the role. In terms of Inspection Readiness, the PV Scientist Manager undertakes activities as delegated by the QPPV, maintains a state of inspection readiness, and acts as a representative and point of contact for Health Authority Inspections and Internal Process Audits within their role and responsibilities. Contributing to the Global Patient Safety (GPS) team, the PV Scientist Manager assists in developing, improving, and standardizing pharmacovigilance processes and methods. They also participate in teams for implementing new processes and methods within the Therapeutic Area. Basic Qualifications and Experience: - Masters or Bachelor's degree in a relevant field - Minimum of 9+ years of experience The PV Scientist Manager's role encompasses a wide range of responsibilities in pharmacovigilance, risk management, regulatory activities, and inspection readiness, contributing significantly to the safety and effectiveness of pharmaceutical products.,

The Clinical Data Manager is responsible for overseeing all data management activities pertaining to the conduct of Phase I-IV clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met. Participate as the primary data management representative on the QED multidisciplinary project teams and as the primary point of contact for all data management interactions with the Sponsor. Participate in protocol developments and review, in review of clinical study reports and statistical analysis plan, in the development of data dictionaries complete with variables, value specifications and coding standards, and in monitoring the quality of data management processes, data, and performance. Review and provide inputs to CRF design and CRF Completion Instructions, database design, data management/data validation plans, data entry guidelines, and revisions to the Standard Operating Procedures. Manage resource planning methodologies and project management to ensure study deliverables and timelines are met in collaboration with the Sponsor, the Sponsor change order process, and to ensure effective communication exchange between the multidisciplinary project teams. Assist/Work with Sr. Management in identifying, developing, and implementing processes to improve/enhance time and cost efficiencies, to provide current information and potential impact of changes on project deliverables and timelines, to identify trouble-shoot issues and provide proposed solutions for problem resolution, to evaluate future potential data management solutions (e.g. functional service provider models, EDC systems) and prepare a business plan, to individual development, training, knowledge, and expertise through research, technical bulletins, and attending appropriate seminars, and to endorse and convey QED's corporate mission statement. Qualifications/Experience: - Bachelor's/Master's degree in computer science, statistics, clinical research, biotechnology, from an appropriately accredited institution. - Minimum of 5 years of data management experience. - Project management experience is required. - Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required. - Direct management of employees within Clinical Data Management is preferred.,

As an Associate Director, Study Site Engagement at Takeda, you will play a key role in enhancing engagement and providing added value by establishing and nurturing long-term relationships with investigators and study site personnel. You will support study teams with trial operations from Feasibility through CSR within the assigned region or countries across Takeda therapeutic areas. Your responsibilities will include supporting country and site identification, feasibility, site selection, study recruitment strategies, and mitigating barriers at the direction of Clinical Programs. You will be responsible for Study Specific Engagement activities, such as early engagement for country and site feasibility, supporting the development of study site lists for feasibility, attending Pre-Study Visits, tracking start-up hurdles, supporting recruitment strategy and activities, and ensuring compliance with applicable local regulations and SOP trainings. Additionally, you will interact closely with local CRO teams throughout the lifecycle of the study and attend Investigator Meetings as required. In addition to study-specific activities, you may also be involved in Non-Study Specific Engagement activities, such as people management, establishing communication with regional/country Medical Affairs, and participating in SSE Program Lead and/or SSE Study Lead roles for assigned programs. You may also be responsible for developing and maintaining long-term strategic relationships with selected sites to improve the site and Takeda experience. To qualify for this role, you should have a scientific degree in pharmaceutical science, chemistry, biology, or healthcare, with 10+ years of experience in clinical research. You should have advanced knowledge of clinical trials processes, regulations, and ICH-GCP, as well as strong communication and influencing skills. Fluency in spoken and written English is required. This position is field-based with monthly visits to the Takeda Delhi/Mumbai office, and travel in the assigned region may be required up to 40% during busy periods. If you are looking for a patient-focused company that empowers its employees to work towards their potential and make a difference in the healthcare industry, Takeda could be the right place for you to take charge of your future and contribute to our inspiring mission of delivering Better Health and a Brighter Future to people around the world.,

As a Manager, Medical Writing & Research Affairs at TECCRO, you will play a crucial role in preparing high-quality scientific documents, including clinical study reports, research papers, regulatory submissions, and publications for medical journals. Your responsibilities will involve collaborating closely with clinical and research teams to ensure that manuscripts meet publication standards for major medical journals and align with the latest scientific research and TECCRO's clinical objectives. Your role will also require you to conduct thorough literature reviews, contribute to the design of clinical trials, and stay updated with current scientific and clinical advancements in the fields of medical aesthetics, skincare, and clinical trials. Additionally, you will work closely with internal teams, including clinical researchers, data managers, and regulatory affairs, to support the alignment of documents with clinical objectives and regulatory standards. Your expertise in medical writing will be essential for supporting business development efforts, including proposal creation and client communication. You will also assist in the preparation of regulatory submissions, ensuring that scientific documents align with required formats and regulatory guidelines. To excel in this role, you should possess exceptional writing, editing, and proofreading skills with a meticulous attention to detail. A strong understanding of clinical research methodologies, regulatory guidelines, and Good Clinical Practices is required. Proficiency in using writing and reference management software, along with excellent collaboration skills, will be beneficial for effectively working across cross-functional teams. If you are a skilled medical writer with a passion for science and research, this role offers an exciting opportunity to contribute to the advancement of clinical research and academic publications within the growing field of medical aesthetics. TECCRO provides a competitive salary with performance-based incentives, opportunities for professional development, certifications, and career growth, along with a supportive and collaborative work environment focused on research excellence and innovation in clinical trials. Join us at TECCRO and be a part of driving scientific and technological innovation in the aesthetics industry!,

The position of DM DNB Cardiologist is a vital role within our healthcare organization in Narela, Delhi. As a Cardiologist, you will be responsible for providing specialized care to patients with cardiovascular issues, contributing significantly to the success of our cardiology department. Your key responsibilities will include diagnosing and treating various heart conditions and diseases, performing and interpreting diagnostic tests such as echocardiograms, stress tests, and cardiac catheterizations, prescribing medications, and advising patients on managing their heart health. You will collaborate with a multidisciplinary team to develop comprehensive treatment plans and conduct rounds in hospital wards to monitor and provide care to inpatients. It is essential to stay updated with the latest advancements in cardiology, integrate new techniques into practice, participate in research activities and clinical trials related to cardiology, provide guidance and mentorship to junior medical staff and residents, ensure compliance with healthcare regulations and standards, and contribute to patient education and public awareness programs on heart health. To qualify for this role, you must have a Doctor of Medicine (DM) in Cardiology, DNB Super Speciality in Cardiology, a valid medical license to practice as a Cardiologist in Delhi, and proven experience in a clinical Cardiology setting. Excellent diagnostic and decision-making skills, strong communication and interpersonal abilities, the ability to work effectively in a multidisciplinary team, up-to-date knowledge of cardiovascular disease management, commitment to continuous learning and professional development, as well as empathy and compassion towards patients and their families are also required. If you possess skills such as patient care, clinical cardiology, research activities, communication, mentorship, patient education programs, cardiovascular disease, compassion, diagnostic tests, clinical skills, compliance with healthcare regulations, prescribing medications, collaboration, clinical trials, rounds in hospital wards, and healthcare, we encourage you to contact 6398652832 to explore this exciting opportunity further.,

Precision for Medicine is looking for an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. In this role, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans under direct supervision. Your responsibilities will include data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment. The Clinical Data Associate/Senior Clinical Data Associate will provide data management support and assistance in all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. You will follow SOPs/WIs, regulatory directives, study-specific plans, and guidelines. This position may involve database development and testing, as well as additional data management activities. Key responsibilities of the role: - Support the Lead DM as a backup or team member, ensuring continuity, responsiveness, and timely task completion - Perform data entry for paper-CRF studies and ensure quality control of data entry - Provide input into timelines, assess resource needs for projects, and ensure clinical data management deadlines are met with quality - Assist in developing CRF specifications from the clinical study protocol and coordinate review/feedback - Assist in building clinical databases and conduct database build UAT - Specify requirements for edit check types and maintain data management documentation - Train clinical research personnel on study-specific items as needed - Review and query clinical trial data according to the Data Management Plan - Perform medical coding of medical terms for logic and consistency - Assist with coordinating SAE/AE reconciliation and liaising with third-party vendors - Assist with SAS programming and quality control of SAS programs - Identify and troubleshoot operational problems and provide feedback on protocols and reports - Participate in the development and maintenance of SOPs related to data management - Communicate with study sponsors, vendors, and project teams regarding data issues - Present software demonstrations/trainings and participate in project meetings - Perform other assigned duties. Qualifications: - Minimum 4 years of experience in Data Management - Bachelor's degree in a scientific/science field with related experience - Proficiency in Microsoft Office tools - Strong organizational and communication skills - Basic knowledge of drug, device, or biologic development and data management practices Preferred qualifications: - Experience in a clinical, scientific, or healthcare discipline - Medical coding knowledge (MedDRA and WHODrug) - Understanding of CDISC standards - Oncology and/or Orphan Drug therapeutic experience Skills: - Strong knowledge of ICH-GCP, Precision Oncology SOPs, and regulatory guidance Competencies: - Motivates project team members and focuses on continuous improvement - Resolves project-related problems and prioritizes workload effectively - Demonstrates self-motivation and professionalism - Works well independently and in a team environment Precision for Medicine is a precision medicine CRO dedicated to advancing the science of precision medicine across various therapeutic areas. All data provided during the application process will be handled in accordance with the Privacy Policy. Applicants with disabilities requiring accommodations can contact Precision Medicine Group for assistance. Note: Precision for Medicine warns applicants about potential fraudulent offers and emphasizes that all job offers will involve communication with the recruiting team, hiring managers, and a formal interview process.,

Join Amgen's Mission of Serving Patients At Amgen, you play a significant role in making a difference. The shared mission of serving patients living with serious illnesses is at the heart of everything we do. Since 1980, Amgen has been a pioneer in the biotech world, combating some of the toughest diseases globally. Our focus on Oncology, Inflammation, General Medicine, and Rare Disease allows us to impact millions of patients annually. As a member of the Amgen team, you will contribute to researching, manufacturing, and delivering innovative medicines that improve and extend the lives of patients. Our culture at Amgen is recognized for its collaboration, innovation, and science-driven approach. If you thrive on challenges and the opportunities they bring, you will find a fulfilling career with us. Join us at Amgen to not only transform your career but also transform the lives of patients for the better. Senior Manager - Data Strategy & Governance In this pivotal role, your primary responsibility will be to operationalize the Enterprise Data Council vision within specific domains such as Research, Clinical Trials, Commercial, and more. You will coordinate activities at a tactical level, interpreting the Enterprise Data Council's directives, defining operational impact deliverables, and taking actions to establish solid data foundations within designated domains. Collaborating with senior leadership and other Data Governance functional leads, you will align data initiatives with business objectives. The Data Strategy and Governance Lead will set and enforce data governance policies and standards to ensure high-quality data that is easily accessible, reusable, and connects seamlessly to accelerate the development of innovative AI solutions that better serve patients. Roles & Responsibilities: - Oversee data governance and data management within a specific domain of expertise (Research, Development, Supply Chain, etc.). - Lead a team of Data Governance Specialists and Data Stewards focused on a particular domain. - Implement the Enterprise data governance framework operationally, ensuring alignment with the broader collaborator community's data governance needs, including data quality, access controls, regulatory compliance, master data management, data sharing, communication, and change management. - Collaborate with Enterprise MDM and Reference Data teams to enforce standards and promote data reusability. - Drive cross-functional alignment in designated domain(s) to uphold Data Governance principles. - Provide expert guidance on business processes and system design to support data governance and data/information modeling objectives. - Maintain documentation and serve as an expert on data definitions, standards, flows, legacy structures, common models, harmonization, etc., within assigned domains. - Ensure compliance with data privacy, security, and regulatory policies in the assigned domains. - Establish enterprise-level standards for information nomenclature, content, structure, metadata, glossaries, and taxonomies. - Partner with Technology teams, business functions, and enterprise units to define specifications that shape the development and implementation of data foundations. What we expect from you Basic Qualifications: - Masters degree with 8 to 10 years of Information Systems experience OR - Bachelors degree with 10 to 14 years of Information Systems experience, OR - Diploma with 14 to 18 years of Information Systems experience - 4 years of managerial experience directly leading people and leadership experience in managing teams, projects, or programs. - Technical proficiency with a deep understanding of Pharma processes, preferably specializing in a specific domain (e.g., Research, Clinical Trials, Commercial, etc.). - Awareness of industry trends and priorities with the ability to apply them to governance and policies. - Extensive knowledge and experience with data governance principles and technology; capable of designing and implementing Data Governance operating models to drive Amgen's transformation into a data-driven organization. - Profound understanding of data management, common data models, metadata management, data quality, master data management, data stewardship, data protection, etc. - Experience in the development lifecycle of data products, including enabling data dictionaries and business glossaries to enhance data products" reusability and promote data literacy. Preferred Qualifications: - Collaborate on developing data foundations and products in conjunction with functions and Digital teams. - Successfully implement complex projects in a fast-paced environment and manage multiple priorities effectively. - Proficient in managing project or departmental budgets. - Familiarity with modeling tools like Visio. - Basic programming skills, experience with data visualization and data modeling tools. - Experience working with agile development methodologies such as Scaled Agile. Soft Skills: - Ability to cultivate business relationships and grasp end-to-end data usage and requirements. - Excellent interpersonal skills with a focus on teamwork. Proficient in people management within a matrix or direct line function. - Strong verbal and written communication skills. - Effective collaboration with global, virtual teams. - High level of initiative, self-motivation, and the ability to manage multiple priorities successfully. - Team-oriented mindset, dedicated to achieving team goals. - Strong presentation and public speaking abilities. - Attention to detail, commitment to quality, effective time management, and customer-centric focus. What you can expect from us At Amgen, we prioritize your professional and personal growth and well-being as we work together to develop treatments that benefit others. Our competitive benefits and collaborative culture support you at every stage of your journey. In addition to a competitive base salary, Amgen provides comprehensive Total Rewards Plans that align with local industry standards. Apply now for a career that transcends imagination. The opportunities ahead are within your reach. Join us at careers.amgen.com. Amgen's commitment to advancing science to serve patients is upheld by fostering an inclusive environment of diverse, ethical, committed, and highly accomplished individuals who respect each other and embody the Amgen values. Together, we stand united in the battle against serious diseases. Individuals with disabilities will receive reasonable accommodation to engage in the job application or interview process, perform essential job functions, and access other benefits and privileges of employment. Please contact us to request accommodation.,

Help bring cutting-edge medical treatments to life by becoming a key player in clinical research and accelerating advancements in healthcare. Explore two pathways into the dynamic world of clinical research: Internship: Embark on a hands-on introduction to clinical trials through a structured internship program. This opportunity is ideal for students or recent graduates eager to gain valuable experience in the field. Fresher-Level Position: Kickstart your career as a Clinical Research Coordinator! This position provides continuous employment for individuals dedicated to this exciting field. Regardless of the chosen path, you will have the opportunity to: - Manage the flow of clinical trials: Oversee study logistics, participant documentation, and ensure seamless progress in the study. - Maintain meticulous records: Collect and safeguard essential research data adhering to the highest industry standards. - Advocate safety and ethics: Safeguard patient rights and ensure all research practices comply with ethical standards. - Collaborate with a team of professionals: Work closely with investigators, healthcare providers, and fellow research enthusiasts. Qualifications: Internship: Enrolled in or a recent graduate of a degree program in life sciences, health sciences, nursing, or a related field. Fresher-Level Position: Recent graduate with a degree in life sciences, health sciences, nursing, or a related field. For both roles, a passion for research, attention to detail, strong organizational skills, effective communication, and a willingness to learn are essential. What We Offer: - Hands-on experience: Jumpstart your career or gain real-world training. - Training and mentorship: Receive guidance from experienced researchers in the field. - Professional development: Access resources and company-sponsored coursework to enhance your skills. - Competitive compensation: Interns receive a stipend; fresher-level positions offer a salary and benefits package. - A role at the forefront of medical innovation: Contribute to shaping the future of healthcare through your work in clinical research.,

As a Senior Insights Associate located in Gurgaon with a hybrid work mode in the Pharma/Life Science industry, your main role is to generate forecast inputs and assumptions for a syndicated drug-level forecast database product in Global Market Insights, reporting to the Manager, Data Analytics. Your responsibilities include building and analyzing country-specific forecast assumptions for multiple indications using secondary sources and your understanding of therapy area, as well as rectifying inconsistencies/gaps in data by utilizing secondary data sources. You will provide manual inputs and assumptions to enhance automated drug-level forecasts, understand and manipulate quantitative data, and ensure the quality and timeliness of input data capture and assumptions. To qualify for this role, you should have a B Pharma/M Pharma/Biotech, MBA in Pharma with experience in pharmaceutical data, along with 2-4 years of relevant work experience. An understanding of the pharmaceutical domain, major economies" pharmaceutical environments, and prior experience in pharmaceutical forecasting and advanced Excel are advantageous. Additionally, you must be diligent in conducting secondary research using search engines and clinical trial websites. Your contribution will support the Manager in maintaining a consistent approach to applying inputs and assumptions across drug classes, countries, and diseases to create standardized outputs that can be segmented by key industry dimensions. Your attention to detail and ability to generate test sets for comparison to automated data outputs will be crucial in this role.,

As an Ophthalmologist Retina Surgeon, you play a crucial role in providing specialized eye care, particularly in diagnosing and treating disorders of the retina. Your responsibilities include performing surgical procedures on the retina and vitreous, diagnosing and managing retinal conditions such as macular degeneration, diabetic retinopathy, and retinal detachments, utilizing advanced retinal imaging techniques for diagnosis and treatment planning, participating in multidisciplinary team meetings to discuss complex cases, providing pre-operative and post-operative care to patients undergoing retinal surgery, using lasers and other precision instruments for surgical interventions, training and supervising medical staff and residents in retinal surgical techniques, participating in research activities and clinical trials related to retinal diseases, collaborating with other ophthalmologists and healthcare professionals for comprehensive patient care, and communicating treatment plans and prognosis to patients and their families. To qualify for this role, you must hold a medical degree (MBBS/MD) with specialization in Ophthalmology, have completed a fellowship in Vitreo-Retinal Surgery, possess a valid medical license to practice as an Ophthalmologist, be board certified in Ophthalmology with a focus on retinal diseases, have a minimum of 2-5 years of experience in retinal surgical interventions, demonstrate expertise in interpreting retinal imaging and diagnostic tests, exhibit strong surgical skills, particularly in vitrectomy and retinal laser procedures, showcase excellent clinical decision-making abilities for complex retinal cases, be proficient in using ophthalmic diagnostic and surgical equipment, possess exceptional communication and interpersonal skills for patient interactions and team collaboration, and show a commitment to ongoing professional development and staying updated with advancements in retinal care. If you are passionate about surgery, communication, collaboration, team collaboration, medical imaging, clinical decision-making, interventions, treatment planning, patient care, professional development, diagnosis, advanced retinal surgery, interpersonal skills, ophthalmology, clinical trials, and completion, this role may be a great fit for you. For further information, please contact Mr. Manoj Thenua at 63986528-32.,

Description We are seeking a highly organized and detail-oriented Schedule Y to join our team in India. The ideal candidate will play a crucial role in managing project timelines and ensuring the successful execution of projects. Responsibilities Develop and implement project schedules using appropriate software tools. Monitor project timelines and ensure adherence to deadlines. Collaborate with project teams to update schedules and communicate changes. Identify potential scheduling conflicts and propose solutions. Prepare and present schedule reports to stakeholders. Skills and Qualifications Proficiency in project scheduling software (e.g., MS Project, Primavera). Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work under pressure and manage multiple projects. Bachelor's degree in Engineering, Project Management, or a related field.

As a Manager of Biostatistics at Syneos Health, you will play a crucial role in ensuring that the Biostatistics department meets project timelines, delivers high-quality results, adheres to project requirements and SOPs, and operates within budget constraints. Your responsibilities will include participating in the development of department SOPs, overseeing staff development and training, promoting standardized processes, and facilitating succession planning. You will be responsible for setting goals for direct reports, managing their performance, identifying training needs, supporting development plans, mentoring, and coaching staff members. By actively participating in hiring, onboarding, transferring, and terminating staff, you will maintain a diverse team with the necessary skills and competencies to fulfill the department's business objectives. In addition to maintaining a good understanding of clinical drug development, regulatory guidelines, and biostatistics, you will provide mentorship within the Biostatistics department and conduct training for associates. Your role will involve prioritizing activities across projects, resolving project conflicts, assigning Biostatisticians to projects, conducting senior reviews of project deliverables, and leading or participating in multiple studies or programs. Furthermore, you may support business development activities, lead departmental or corporate initiatives, and undertake other work-related duties as assigned. Travel requirements for this role are minimal. To qualify for this position, you should hold a graduate degree in biostatistics or a related discipline and possess extensive experience in clinical trials or a relevant field. Previous management experience or demonstrated leadership abilities are preferred. A solid understanding of the drug development process, regulatory requirements, and relevant guidelines is essential, along with proficiency in English communication. Excellent interpersonal skills, including communication, presentation, and influencing abilities, are also required. At Syneos Health, we are dedicated to developing our employees, fostering a supportive and inclusive work culture, and creating a diverse and collaborative environment. Join us in our mission to accelerate customer success and make a meaningful impact in the biopharmaceutical industry. Please note that the tasks, duties, and responsibilities outlined in this job description may not be exhaustive. The Company reserves the right to assign additional tasks or responsibilities at its discretion. Qualifications may vary based on equivalent experience, skills, and education. This job description does not constitute an employment contract and is intended to comply with all applicable laws and regulations governing employment practices.,

The Associate Clinical Development Director (Assoc. CDD) plays a crucial role in contributing to the development of protocols for assigned global clinical trials, monitoring scientific aspects, and ensuring the reporting of high-quality data. Depending on the size and complexity, they may also provide support in developing the clinical and scientific strategy for specific sections of a clinical development program. Their responsibilities encompass overseeing all operational aspects of clinical trials, from planning and execution to interpreting research findings and managing data collection activities and clinical operations. Additionally, they are responsible for complete oversight of budget and resource allocation within the assigned trial, driving operational excellence through process improvement and knowledge sharing across trials within the program or franchise. The Associate Clinical Development Director serves as a point of escalation for resolving operational issues within the assigned trial. In their role, the Associate Clinical Development Director is tasked with providing input to the development of clinical development strategy, contributing to the development of trial-related documents, and collaborating with the appropriate Clinical Trial Team (CTT) members. They conduct ongoing scientific reviews of clinical trial data, manage patient safety reports, provide input into final analyses and interpretations, and contribute to global initiatives for process improvement and other line function activities. The Associate Clinical Development Director may also lead clinical trials as a Clinical Scientific Lead, providing leadership and guidance for all clinical aspects of the trial in collaboration with the medical monitor and/or Clinical Development Director. Key Performance Indicators for the role include demonstrating quality clinical and scientific strategic input, applying effective clinical research methodology, supporting Therapeutic Area (TA) through high-quality contributions, and ensuring timely development of disease/program clinical standards, publications, and presentations. The Associate Clinical Development Director is expected to excel in executing and implementing clinical operations strategy, managing budget and resources effectively, and demonstrating strong leadership skills to support team competency building and best practice sharing across programs and departments. Clear communication of risks, cost-effective management, and adherence to Novartis Values and Behaviors are also essential aspects of the role. Minimum Requirements for the position include a preference for Neuroscience or similar experience, an advanced degree in life sciences or healthcare, and at least 3 years of involvement in clinical research or drug development in an academic or industry environment. The ideal candidate should have a working knowledge of clinical trial design and methodology, statistics, regulatory processes, and strong communication and interpersonal skills. Proficiency in budget management, clinical research, coaching, cross-functional teamwork, and risk management is also necessary. Language requirements for the role include proficiency in English. Novartis offers a collaborative environment for individuals passionate about making a difference in patients" lives through innovative science. If you are ready to contribute to creating a brighter future, consider joining the Novartis Network to explore career opportunities and benefit from a supportive community focused on personal and professional growth.,

As a Statistical Modeller - Clinical, you will be responsible for utilizing your expertise in clinical trials and clinical data monitoring to develop and implement statistical models. Your role will involve working with Bayesian and Frequentist models, as well as handling EDC, CTMS, ePro, and eCOA systems. You will also be involved in RBQM, signal detection, KRI analysis, and outlier detection. In this position, a strong understanding of GCP ICH E6/8 and EMA Guidelines is essential. Proficiency in statistical software such as SAS, R, JMP Clinical, and Python will be required for data analysis and modelling. Experience with visualization tools like Tableau and Power BI will also be beneficial. Additionally, familiarity with project management tools like Jira and Confluence is necessary to collaborate effectively with cross-functional teams. An advanced knowledge of R, HTML, and GitHub will further support your role in this dynamic environment.,

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

Let s build the future of medicine together. Join Enveda as an Research Associate / Senior Research Associate In Vitro ADME in Hyderabad, India, and help us transform natural compounds into life-changing medicines. We re a team driven by curiosity and innovation are you ready to make a difference On-Site | Hyderabad, India | Full-Time | What Makes Us Enveda Life is smart, and we can learn from it. We re reinventing drug discovery by harnessing nature s intelligence. Our platform identifies new medicines four times faster than the industry standard because patients can t wait. What sets Enveda apart isn t just what we do it s how we do it. Our culture is built on creativity, collaboration, and deep respect for each other. We believe People Create All Value, and our success is driven by the extraordinary team turning our mission into reality every day. We re proud of the momentum we ve built: - Jan 2024: Named a LinkedIn Top Startup to Watch - Mar 2024: Forbes America s Best Startup Employers - Oct 2024: First drug to Phase 1 Clinical Trials - -Dec 2024: Raised a $130M Series C These milestones reflect the impact of our team and we re just getting started, but they re only possible because of the diverse talent, perspectives, and relentless drive of our team, and people like you. Your Role in Our Mission At Enveda, every role drives impact. As a Research Associate / Senior Research Associate In Vitro ADME , you ll be at the forefront of delivering hope to patients everywhere. Your expertise in in vitro ADME studies will be critical in advancing our novel therapeutics from lab to clinic because every breakthrough starts with bold questions and brave actions. What You ll Do Design and execute in vitro ADME studies for novel compounds Optimize and validate protocols for reliable assay performance Analyze and interpret data to inform drug discovery strategy Collaborate with cross-functional teams to meet project milestones Mentor junior scientists and stay current with evolving methodologies We re Looking For: Master s degree in Pharmaceutical Sciences or related field 5 7 years of relevant industry experience in DMPK Hands-on experience with microsomal/hepatocyte assays and LC-MS/MS or HPLC Strong problem-solving mindset and excellent communication skills If you re passionate about innovation and impact, we encourage you to apply even if you don t meet every requirement. Our Values: Curiosity | Agency | Journey | Charity | Unity Benefits: Culture | Medical | Block Leaves | Work-Life Harmony At Enveda, we re building a place where everyone can do the best work of their life. We are an equal opportunity employer and value diversity in all its forms. Apply now and join a team committed to shaping the future of drug discovery.

Deenanath Mangeshkar Hospital is looking for RESEARCH DOCTOR CLINICAL TRIALS to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes

Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do #NTRQ Required Qualifications: Bachelor’s degree or master’s degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone – of every race, gender, sexuality, age, location and income – deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes – an enterprise priority reflected in our mission. External Candidate Application Internal Employee Application

Looking for a motivated individual to join our team as a Trainee Medical Reviewer in Bengaluru. The ideal candidate should have 0-1 years of experience. Roles and Responsibility Conduct thorough medical reviews of patient records and reports to ensure accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to identify and resolve issues related to medical review. Develop and maintain expertise in medical terminology, regulations, and guidelines. Provide high-quality support to internal stakeholders through effective communication and documentation. Stay updated with changes in regulations and guidelines affecting medical review processes. Participate in quality improvement initiatives to enhance the efficiency and effectiveness of medical review activities. Job Requirements Strong understanding of medical terminology, regulations, and guidelines. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a team environment and communicate complex information clearly. Proficiency in using electronic health records systems and other healthcare software applications. Strong organizational and time management skills with the ability to prioritize tasks and meet deadlines. Commitment to delivering high-quality results and maintaining confidentiality and professionalism. Omega Healthcare Management Services Private Limited is a leading provider of healthcare management services, committed to delivering exceptional care and customer satisfaction. We are an IT-enabled services company that uses technology to improve healthcare operations and outcomes.

Looking for a skilled Engineer - Voice Support to join our team at Omega Healthcare Management Services Pvt. Ltd., located in Navi Mumbai I. The ideal candidate will have 2-4 years of experience. Roles and Responsibility Provide technical support and resolve customer complaints via phone, email, or chat. Troubleshoot and diagnose issues with software applications and hardware systems. Collaborate with cross-functional teams to identify and implement solutions. Develop and maintain documentation of technical procedures and knowledge base articles. Analyze customer feedback and suggest improvements to processes and procedures. Participate in training and development programs to enhance skills and knowledge. Job Requirements Strong understanding of CRM/IT Enabled Services/BPO industry trends and technologies. Excellent communication and problem-solving skills are essential. Ability to work in a fast-paced environment and handle multiple tasks simultaneously. Strong analytical and troubleshooting skills are required. Experience with Vasta Bio-Informatics Private Limited is preferred. Familiarity with industry-standard tools and software applications is desirable.

Job Tittle - R&D Clinical Trial Support Associate Location - Hyderabad About the job The Clinical Trial Support Associate (CTSA) plays a pivotal role in supporting the Clinical Operations Study Leader (COSL), Global Study Leader (GSL for EDCO) and the Clinical Operations Study Country Leader (COSCL) throughout the entire lifecycle of clinical studies. The CTSA is entrusted with managing a wide range of study, country, and site-level activities delegated by the COSL, GSL and COSCL, ensuring seamless execution and delivery of clinical trials. As the central point of oversight, the CTSA coordinates activities across all levels within a study, maintaining a comprehensive view of study progress. They collaborate closely with the COSL/GSL to prepare study-related plans and materials, escalate issues appropriately, identify study risks, develop contingency plans, and monitor the study plans adherence. Additionally, the CTSA supports the COSCL in managing country or site-specific tasks, ensuring compliance and smooth operations. The CTSA also assists in the overall management of budget tracking and invoice approval, working alongside the clinical study leader and the clinical study country leader. They liaise with site monitors as needed to ensure site-level study compliance, acting with critical thinking and a problem-solving mindset. The CTSA executes tasks with integrity, ensuring all activities are suitable for regulatory review. Other key stakeholders include the Clinical Trial Support Manage (CTSM), vendor managers and any other study team member. The COSL, GSL and the COSCL provide oversight of the CTSAs activities, depending on whether they pertain to study or country-level operations. Main responsibilities include: Ensure study and site communication and documentation tasks Facilitate site and study team communication by distributing protocol amendments and Investigator Brochure updates. Develop and disseminate study newsletters and mass site communications (newsletters, memos). Maintain documentation tasks including ICF tracking logs, Patient Data Report (PDR) distribution and tracking, equipment leasing coordination, insurance request management, site training tracking, and whos who list maintenance. Supports completion of all study documents with the various study team members Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant Sharepoint locations as required. Ensure Financial management tasks Process study, investigator and vendor payment requests, manage invoices, create and track purchase orders (POs), and report payment statuses to COSL/GSL/COSCL and site monitor. Set up CTMS at study, country, and site levels, create and maintain site accounts, manage system access and manage tool access requests, for phase 1 studies maintain CTMS updated if applicable Conduct IPC (In-Process Control) checks at study, country, and site levels, support inspection readiness. Strong written and verbal communication skills. English language skill: ability to exchange fluently write meeting minutes/ emails/ study documents, internal & external communications. E xperience in clinical operations and managing clinical studies is preferred. Readily adapt to new environment, technologies and processes (e.g. new digital tools) Good organizational skills: ability to multi-task, skill in establishing priorities and meeting deadlines Experience in clinical operations and managing clinical studies is preferred. About you E xperience in clinical operations and managing clinical studies is preferred. Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA (Food and Drug Administration) and EMA (European Medicines Agency), and SOPs/ QDs. Proficiency in CTMS and financial management experience or ability to quickly learn new systems and processes. Education: Bachelors degree in life sciences, healthcare administration, or related field or equivalent experience Assist with audit/inspection preparation and contribute to elaborate proper responses to audit/inspections, and provide PAI (Pre-Approval Inspection) readiness admin support. Prepare CSR appendices, manage BIMO activities, Audit and inspection administrative activities. Support access management for any tool/system used for the clinical trial Monitor CTMS compliance, generate and distribute reports, and oversee system data quality. Ensure CTMS & Systems Administration tasks Track budgets at study, country, and site levels, ensuring accurate payment status reporting and effective vendor management in finance systems.

Job Overview Provide medical expertise on pharmacovigilance services to divisions as requested The Associate Medical Safety Director participates in all aspects of Medical Safetys involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors, Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a products safety profile Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Represent safety and clinical data review findings during client meetings Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies Provide medical oversight for label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings Attends and contributes medical safety evaluation on Safety Monitoring Committees Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture, Act as Global Safety Physician or Assistant or Back-up on projects as assigned Attend project meetings, medical safety team meetings, and client meetings as requested Ensure coverage for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projects Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects 24 hour medical support as required on assigned projects Maintain awareness of medical-safety-regulatory industry developments Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req Three (3) years of clinical practice experience ( e-g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role Or equivalent combination of education, training and experience Req Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice Knowledge of clinical trials and pharmaceutical research process Ability to establish and meet priorities, deadlines, and objectives, Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide Learn more at https://jobs iqvia Show