Responsibilities Recruit and Develop CRAs and implement necessary actions to improve their performance. Lead quality clinical trial projects (CDP and/or local) in the country. Provide trial related communication and insight to key internal and external stakeholders. Coordinate the clinical trial set-up in partnership with the COM. Maintain ongoing communication with Ethics Committees and the Health Authority, ensuring the Central and local (as applicable) Ethic Committee is provided with the documents requested.   Qualification & Experience 8 to 10 years of experience in managing global clinical trials as CRA/Sr. CRA (approx. 6 yrs) and Team lead/Trial Manager (aprox. 2 yrs) Currently leading/managing project team of CRAs and or CTAs Candidates with prior experience in handling Diabetes/Obesity/OSCD (Other Serious Chronic Diseases)/Hemophilia/Growth Hormone disorders trials will be preferred  

Responsibilities  Responsible for the content of the statistical sections of various disclosure documents. Ensure full and accurate presentation of data (i.e. All Primary and Secondary endpoints are reported; Checks that tables responding to each endpoint, including safety are presented; Demographic table and Statistical Methods sections appropriately developed. Responsible for development of Results specification file for development of automated output for the result summaries.   Collaborate with Project- Statisticians on clarifying disclosure related requirements and timeliness of deliverables. Provide appropriate guidance to project statisticians to ensure all required data needed for disclosure is generated through review of the Statistical Analysis Plan and TFL (Tables, Figures & listings). Ensures Quality control of the results summaries with consistency between summaries, according to the standards and in alignment with the study report content (including Full CSR versus results summary if needed). Involvement in patient level data sharing, on a need basis to provide support with data anonymization of statistical output. Partners with clinical study team members to ensure disclosure requirements are addressed early during the process of protocol development. Reviews protocol/ concept protocol as appropriate, for compatibility with requirements of external registers. Support consistent process for trial disclosure activities throughout the therapy area. Contribute to the development of procedural documentation including guidance documents and / or instructional documents. Support maintenance and improvement of processes for disclosure function according to evolving requirements. Update Disclosure systems for disclosure activities planning, tracking and delivery. Ensures archival of final records in applicable systems for the posting of the documents on the required registries. Support risk management framework implementation, including risk identification, assessment and prioritization and the definition of mitigation plans. Support risk mitigation for identified business transparency risks and manage the implications of these risks on disclosure documents. Contribute to the development of training material for the business, clinical support services and service provider(s). Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translate into GSK’s Clinical Trial Disclosure and Transparency processes.    

Responsibilities Responsible for the support and/or development of new or existing systems, tools, and technologies for GPS systems. Uses standard validation principles and system development methodologies to create and maintain GPS-based applications for use in operations and processes. Strategically influence and drive the change management process for GPS owned systems. Knowledge of data migration/data transfer process involving GPS data. Responsible for the configuration of GPS safety system such as global reporting rules and conducting Product License Study (PLS) activities. Acts as a SME for GPS system configuration activities (i.e. ERR and PLS processes). Supports GPS and Lilly safety reporting needs through the creation of existing/adhoc queries and/or visualizations. Maintains an understanding of GPS systems data in order to ensure reports meet GPS/Lilly needs. Ensures appropriate review and validation of output for accuracy. Provides support to GPS functional areas; interacts with GPS therapeutic teams; facilitates consistency of business practices; assists with the identification and resolutions of process gaps or improvement opportunities; provides input to leadership regarding performance measures and data validation. Proactively communicates with customers, teammates, vendors, and IT groups to align on safety report request requirements and delivery timing. Looks for opportunities to create self-service/enhanced reporting options for GPS/Lilly functional areas. Works across GPS to leverage performance data, compare observations to standards, influence strategic direction, and drive capability improvements. Understanding of safety process knowledge in order to lead/participate in projects across GPS that drive GPS automation, technology and analytics needs. Active engagement in benchmarking in order to highlight opportunities for automation and technology improvements in GPS processes. Provide standard or custom validated reports for use in audits and inspections. Maintains accuracy and performance of routine reports executed by or for GPS. Prepares and maintains records to provide information for summaries, charts, graphs, and monthly or ad-hoc reports. Maintains awareness of existing regulations/guidelines to ensure alignment of deliverables within standard operating expectations. Understands the confidential nature of company information and takes necessary steps to ensure its protection and compliance with all standards. Understand the roles of the EU Qualified Person (QP) and ensures support is provided to fulfill the QP legal responsibilities.   Qualification & Experience Master's/Bachelor’s degree within a health science, Mathematics, Statistics, Computer Science field or equivalent experience.  

Responsibilities Develop high-quality written material (manuscripts, web content, posters, brochures, flyers, etc.) to support the product portfolio. Reviews and evaluates scientific data and technical documents to develop written material. Assists the marketing team in conducting content-need analysis. Provide informal guidance and support to new team members, fostering a collaborative and inclusive work environment. Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results. Review scientific content and offer constructive feedback, drawing upon your knowledge and expertise in biological sciences. Interact with cross-functional teams and customers at multiple locations globally.     Qualification & Experience PhD in Biological sciences, biotechnology or immunology, or a related discipline with 3+ years of experience with bioprocessing. 2+ years’ experience in content creation in an industry setting. Experience in a regulated environment desired.  

Responsibilities Understands the drug development process Applies knowledge of ICON’s policies and procedures Excellent communication, presentation, leadership and interpersonal skills Ability to set expectations and monitor employee performance Ability to identify and hire strong candidates through recruitment process Ability to handle multiple assignments simultaneously and meet deadlines in a fast paced and complex environment Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors Makes effective decisions based on analysis of facts and data, retaining ownership Drives plans to resolve issues escalated from team members Uses data to present ideas, concerns and solutions Breaks problems into component parts and addresses issues until resolution  

Responsibilities Reviewing of preclinical studies as per the regulatory requirements to support the clinical bridging. Data search/retrieval from the literatures and other publicly available sources for clinical and non-clinical queries and other medical deliverables.  Review of preclinical study reports. Designing of protocols for clinical studies(Phase I-Phase IV) for various regulatory submissions. Preparation and review of clinical overview (CO) & Non-clinical overview (NCO) for regulatory submissions. Preparation/review of regulatory submission documents like Scientific advice, Pre-IND package, controlled correspondence and Initial paediatric study plans etc. Supporting to clinical research aspects of products in development and supporting to other miscellaneous activities where medical reviewer intervention is needed. Providing the inputs for SOPs as per regulatory requirements and ICH-GCP to harmonize the activities.   Qualification & Experience MBBS/M.Pharm (Pharmacology)/Phd/BDS/PharmD 5 to 10 years of experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience GNM / BSC Nursing 1 to 5 years of experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience GNM / B.Sc nursing 1 to 5 years of experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience MSC Nursing 2 to 5 years of experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience Graduate, preferably with a background in the hospital industry. Experience: 3 to 10 years of experience required. We are seeking smart, young, and energetic candidates.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"