353 Clinical Development Jobs - Page 13

Provide highly advanced expert support functional and technical leadership to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Develops and applies biostatistics and programming methods to ensure valid conclusions. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other RD areas. To meet challenges in data review, big data, analytics and reporting of clinical trial data may also Independently provide timely and professional leadership of special projects that focus on innovative tools and ...

Ensure compliance with internal and external guidelines, to compile and add electronic navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities (HAs) and provide publishing consultancy to the clinical teams and other line functions. Major accountabilities: In collaboration with the clinical teams, compile, integrate and publish clinical documents with word processing, electronic publishing, and document management systems in the Novartis Development environment. Perform technical quality control (electronic functionality, adherence to internal and external document standards) of published documents. Maintain basic knowledge of curr...

-Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. -Applicable to Clinical Scientific Expert IThe Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is sci...

Updating financial systems with contractual arrangements with clients, staff deployment on projects (staff plans) and deliverables achieved. Preparation of the monthly revenue report comparing actual revenue versus forecast with supporting explanations and calculations for variances. Performing reconciliations of contracts and revenues recognised. Liaising with the billing team regarding unbilled revenue balances. Assisting with monthly reports (forecast, backlog, utilisation). Ensure revenue is recognised within SOX guidelines i.e. relevant controls, documentation, signoffs, and filing are in place. Role Requirements Business/Finance degree or Part Qualified (ACCA, CIMA etc) or both Minimum...

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, mainte...

Assistant Revenue Accountant ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development . Overview of the role Revenue Calculations: Updating financial systems with contractual arrangements with clients, staff deployment on projects (staff plans) and deliverables achieved. Preparation of the monthly revenue report comparing actual revenue versus forecast with supporting explanations and calculations for variances. Performing reconciliations of contracts and revenues recognised. Liaising with the...

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

Career Category Regulatory Job Description Career Category Regulatory Job Description Let s do this. Let s change the world. In this vital role you will maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities. Roles Responsibilities: Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All St...

Key Responsibilities 1. Clinical Oversight Ensure adherence to treatment protocols and SOPs across all units. Monitor clinical indicators, patient outcomes, and audit reports. Guide units on medico-legal processes, compliance, and NABH standards. Review critical incident reports and follow up on action taken. Provide clinical direction during health emergencies or outbreaks. 2. Administrative Coordination Supervise hospital operations remotely through MIS, dashboards, and unit-level coordination. Support policy implementation and resolve escalated clinical-operational issues. Standardize workflows across departments in consultation with Unit Heads. Facilitate inter-unit coordination to maint...

Let s do this. Let s change the world. In this vital role you will maximise domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and develop...

Let s do this. Let s change the world. In this vital role you will leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and develo...

Let s do this. Let s change the world. The role brings to bear domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to mainta...

Oversee safety issues of projects conducted by ICON which will include, but not be limited to, the following: Adverse event reporting to the sponsor Follow up of adverse events as necessary Communication of safety issues to the head of the department or designee Participate in the on-call system for providing 24/7 medical support Provide all necessary medical support functions as defined by project specific contractual obligations which will include, but not be limited to, the following: Medical information source Ongoing training for project teams in therapeutic areas as requested Review of study documentation (protocol, CRF. etc.) Contribute to investigator meeting presentations Ongoing sa...

Data Analyst II ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Data Analyst II to join our diverse and dynamic team. As a Data Analyst II at ICON, you will play a crucial role in analyzing complex datasets to support decision-making and enhance clinical operations and research processes. You will contribute to the advancement of innovative treatments and therapies by providing actionable insights and leveraging data analytics to drive performance across the...

Data Analyst II We are currently seeking a Data Analyst II to join our diverse and dynamic team. As a Data Analyst II at ICON, you will play a crucial role in analyzing complex datasets to support decision-making and enhance clinical operations and research processes. You will contribute to the advancement of innovative treatments and therapies by providing actionable insights and leveraging data analytics to drive performance across the organization. What You Will Be Doing: Conducting thorough data analysis to support clinical trial design and execution. Collaborating with cross-functional teams to identify opportunities for data-driven innovation and optimization within clinical research. ...

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) Man...

What you will do Let’s do this. Let’s change the world. In this vital role you will leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Ma...

The Principal Statistical Programmer ( Programmer ) will have experience in all required areas of a Senior Statistical Programmer. The Principal Statistical Programmer is responsible for providing statistical programming services for assigned clinical trials. This includes acting as the lead programmer for assigned clinical trials. Responsibilities Exceed expectations and responsibilities of a Senior Statistical Programmer Understand and implement CDISC and other regulatory standards Follow internal SAS programming conventions Serve as programming lead on complex clinical trials; or serve as portfolio lead across a large suite of studies for a sponsor Coordinate and ensure the accuracy and c...

Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Relevant Years of experience 3 to 6 years. Perform PV literature surveillance assessment activities according to regulations and agreed processes. Timely production of key deliverables including but not limited to: - Screen and review literature search results (articles/abstracts/citations) for aggregate report inclusion and potential safety signal identification. - Maintain and document up-to-date product knowledge for literature evaluation. Participate in quality or continuous process improvement activities related to area of responsibility Discusses need for, and priority of safety rela...

Image Data Processing Technologist _ Office Based _ Chennai/Trivandrum ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development . We are currently seeking an Image Data Processing Technologist to join our diverse and dynamic team. You will collaborate with cross-functional teams to enhance the efficiency and effectiveness of imaging data in clinical research. What you will be doing Maintain a positive, results-oriented work environment by building partnerships, modeling teamwork as well as com...

Image Data Processing Technologist _ Office Based _ Chennai/Trivandrum . We are currently seeking an Image Data Processing Technologist to join our diverse and dynamic team. You will collaborate with cross-functional teams to enhance the efficiency and effectiveness of imaging data in clinical research. What you will be doing Maintain a positive, results-oriented work environment by building partnerships, modeling teamwork as well as communicating in an open, balanced, and objective manner Verifying incoming documentation and data for GCP/HIPAA violations and responding according to outlined procedures in a timely manner to rectify them Preparing / loading / demographically reviewing data fo...

Customer Service Rep _ Office Based _ Chennai/Trivandrum ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Customer Service Rep to join our diverse and dynamic team. As a Customer Service Rep at ICON, you will play a pivotal role in providing exceptional support to our clients and stakeholders, ensuring their needs are met and enhancing their experience with our services. What you will be doing Responding promptly to customer inquiries via phone, email, or cha...

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. EMS (Executive Medical Summary) Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing pro...

Develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. MSLs will use various channels for interactions (1:1, group presentation; remote, etc). Develop and execute a medical interaction plan with Key accounts (Army, Railways, CGHS etc.) as per the needs of the stakeholders and the overall medical strategy. Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with Thought Leader...

Biostatistician I / II - India - Office Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Biostatistician I to join our diverse and dynamic team. As a Biostatistician II at ICON, you will play a pivotal role coordinating and supervising the work of biostatisticians and programmers, ensuring timely and high-quality deliverables for assigned studies. What you will be doing: Contribute to the design of case report forms with a focus on statistical aspects. ...