5 Ichgcp Jobs

You will play a crucial role in producing key data and reports to support data review reporting development. This involves evaluating requirements, designing specifications, coordinating with programmers, programming reports, and ensuring validation and rollout activities are carried out effectively. You will provide quantitative analytical support independently or as part of a team, with minimal guidance and supervision. Your primary responsibilities will include: - Producing and tracking reports for various line functions within Global Drug Development to monitor clinical data - Creating understandable and actionable reports on clinical data for key stakeholders - Collaborating on user requirements documents, functional specifications, and testing scripts - Interacting with end-users to create specifications and work with programmers for successful delivery - Offering quantitative analytical support to global program teams and assisting in analyzing reports - Supporting the planning, execution, and close-out of Clinical Programs/Trials - Collating and delivering analytics reports for critical decision-making purposes - Maintaining appropriate documentation and working with internal SMEs and key stakeholders to analyze clinical program/trial operational data - Providing training to end-users on the best use of various data review tools - Programming reports of varying complexity within clinical reporting systems using SQL, PL/SQL, C#, VB script, SAS, Python, R - Demonstrating good knowledge of Novartis Clinical Data Standards for creating report specifications or outputs - Supporting special projects of limited scope, both clinical and non-clinical - Offering study-level expertise and involvement in CTTs - Leading or supporting special projects across various responsibilities, such as systems issues, processes, user support, and training Your performance will be evaluated based on: - Quality and timeliness of deliverables - Revisions to deliverables due to logic or programming errors - Customer feedback and satisfaction To be successful in this role, you should have: - At least 5-7 years of experience in clinical review, reporting programming, business analytics, or clinical trial setup in the pharmaceutical, CRO, or Life Science industry - Strong knowledge of programming languages (SQL, PL/SQL, C#, VB script, SAS, Python, R) - Familiarity with Data Review and/or Business Intelligence tools (e.g., Spotfire, JReview) - Understanding of clinical data management systems and relational databases applied to clinical trials - Attention to detail, quality, time management, and customer focus - Ability to communicate technical concepts to non-technical users - Strong verbal and written communication skills for global collaboration - Knowledge of Drug Development Process, ICHGCP, CDISC standards, and Health Authority guidelines - Capability to train and supervise new or less experienced associates Novartis offers a supportive community of smart, passionate individuals dedicated to making a difference in patients" lives. If you are ready to contribute to breakthroughs that change lives, join us in creating a brighter future together. For more information about Novartis and to explore career opportunities, visit: https://www.novartis.com/about/strategy/people-and-culture If you are interested in staying connected with Novartis for future career opportunities, sign up for our talent community: https://talentnetwork.novartis.com/network To learn about the benefits and rewards of working at Novartis, read our handbook: https://www.novartis.com/careers/benefits-rewards Novartis is committed to fostering an inclusive work environment and diverse teams that reflect the patients and communities we serve. If you require accommodation due to a disability, please contact [email protected] with your request and contact information, including the job requisition number.,

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*). The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, you will manage, coordinate, review, and approve DM deliverables from database design & set-up, through cleaning and reporting to database locking. It is crucial to ensure that the completeness, accuracy, and consistency of clinical data meet the quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. You will also be involved in Request for Proposals (RFPs) and present at Business Development (BD) Meetings. As a Senior Clinical Data Manager I, your key tasks will include: - Leading and serving as the primary contact for DM with all relevant parties internally and externally - Planning and projecting the resources required including management of tasks, timelines, risk, and quality - Developing, reviewing, and maintaining project-specific DM documents throughout the project lifecycle - Leading and coordinating the development of clinical study database set-up, eCRF design, and database validation requirements - Creating training materials for EDC users and providing project-specific training - Overseeing data cleaning strategy, data releases, data transfers, and reconciliation activities - Providing project metric reports, status updates, study progress, and feedback to the project team - Maintaining DM study documentation, supporting internal and external audits, and aligning data management and clinical programming best practices - Participating in client evaluations, preparing new proposals and budgets for Data Management services, and staying updated on regulatory development trends Requirements: - Life science, healthcare degree and/or combination of education and experience - Minimum 5 years of relevant work experience as a Clinical Data Manager - Thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and awareness of local/regional requirements - Experience with EDC software systems, IRT, eCOA, and CDISC conventions - Strong written and verbal communication skills, organizational, negotiating, and motivational skills - Ability to work in a fast-paced challenging environment and proficiency with computer applications Benefits of working at Allucent include: - Comprehensive benefits package - Competitive salaries - Departmental Study/Training Budget for professional development - Flexible working hours and remote/office-based working opportunities - Leadership and mentoring opportunities - Internal growth opportunities, employee referral program, and access to online training platforms *This position is for the Chennai Location and not home-based** *Please note that Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.*,

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a skilled SAS Clinical Programmer III with experience in SAS and EDC programming to join our dynamic team. In this role, you will leverage your expertise in SAS programming and clinical data management to support the analysis and reporting of clinical trial data. Your contributions will be pivotal in ensuring the accuracy and integrity of our clinical databases. As a Clinical Programmer III at Allucent, you will lead and coordinate clinical programming activities and maintain clinical databases and other application tools supporting data capture and data processing in compliance with study-specific plans, standard operating procedures, industry standards, and regulatory requirements. You will be part of a small but nimble global team. Credibility, quality, and collaborations are the key pillars that drive this team. We are looking for you to come with an innovative and can-do approach where you can have a quick impact. In this role, your key tasks will include designing, building, testing, and releasing clinical databases to the production environment, including study design specifications, User's Acceptance Test (UAT) test cases, and database configuration settings in support of database set-up and edit checks programming. You will work with SAS and EDC programming, review electronic Case Report Form (eCRF) completion guidelines, develop and/or validate SAS programs for metric reporting, data review listings, data import, and data export set-up. You will also support the application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, review and adhere to the requirements of study-specific data management documents & plans, actively contribute/participate in study team, departmental meetings, sponsor meetings, and use an analytical approach to problem-solving. Collaborating with peers, programmers, study teams to clarify specifications, and using expanded technical skills to meet evolving project needs is also a key responsibility. Additionally, maintaining a broad overall knowledge in the field of clinical programming and clinical data management by reading literatures, self-training, attending training classes, professional meetings, researching and proposing initiatives for improving efficiency, developing and delivering applicable DM departmental trainings, drafting and contributing as a Subject Matter Expert (SME) in the field of Clinical Programming activities to the evaluation/improvement of processes, and procedures within the Quality Management System are essential tasks. To be successful, you will possess a minimum of 2-5 years of relevant work experience in a clinical research and/or drug development organization combined with a degree in Life science and experience in SAS and EDC programming. Computer Science, healthcare, and/or related field degree. You will be a great addition to the team when you are open and transparent, work well together and have a solution-focused approach. Good knowledge of ICH-GCP(R2), GDPR/HIPPA, and applicable (local) regulatory requirements, good understanding of clinical data management processes and experience with tools and systems for managing clinical studies, solid understanding and hands-on experience with CDISC standards (i.e. CDASH, TAUGs, and SDTM models), strong programming SAS skills with proficiency in Electronic Data Capture (EDC) systems, data reporting, and programming languages such as PL/SQL, SAS, and comparable fields, ability to work in a fast-paced challenging environment of a growing company are important traits and behaviors we are looking for. Benefits of working at Allucent include a comprehensive benefits package per location, competitive salaries per location, departmental Study/Training Budget for furthering professional development, flexible working hours (within reason), opportunity for remote/office-based* working depending on location, leadership and mentoring opportunities, participation in our enriching Buddy Program as a new or existing employee, internal growth opportunities and career progression, financially rewarding internal employee referral program, access to online soft-skills and technical training via GoodHabitz and internal platforms, eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects, eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees. *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within a reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.",

Job Title: Medical Data Abstractor (MDA) Department: Delivery Job Location: Turbhe, Navi Mumbai (Work from Office) Reporting To: Lead Job Duties / Responsibilities: Data management and Curation Performs complex data abstraction (i.e. requiring interpretation) and data entry for specified disease and project requirements. Participates and contributes to team meetings and learning sessions. Maintains a high level of medical knowledge and terminology and expertise of electronic medical record and data capture systems. Self-reports activities like time spent on records, audits completed including all relevant details and any other reporting functions assigned by Operations and QA management teams. Quality Assurance Consistently complies with minimum quality levels indicated in the QA plan for each project (>95% or higher accuracy depending on the project). Receives feedback from Quality Analyst and ensures timely reconciliation of errors. Participates in quarterly Inter rater reliability (IRR). Special Projects May lead or participate in special projects or client-specific initiatives as directed. Education and Experience: Graduate / PG - Medicos: BDS, MDS, BAMS, BUMS, BHMS, BPT, MD. 0-5 years of experience in the clinical or non-clinical field. Should be presentable and pleasant. Ability to multitask, work under pressure, and meet deadlines required.,

You will be responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance with SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP, and local regulations. Your duties will include managing all data management aspects of assigned project(s) from setup to lock. You will attend regular meetings with the project team to discuss data management issues and provide status updates for the project. Reporting on quality and performance metrics, including timelines, to project leads and other stakeholders will also be part of your responsibilities. You will participate in in-house and external training courses as required. Additionally, you will be involved in the preparation/review of Data Management process control documents such as Data Management Plan, Data Edit Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, and Coding Guidelines. Coordinating and managing training and EDC access for investigators, coordinators, data entry, and CRAs on selected applications for data entry, cleaning, and running reports will be essential. You will review, freeze, and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency, and validity, generating queries as necessary for sites and/or the project team. Furthermore, you will coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology as required. Maintaining Data Management study documentation in an audit-ready status and performing reconciliation against the clinical database will also be part of your role. You may be required to present at investigator meetings and PM/CRA training sessions and identify and recommend process improvements to the management team as identified. This role has a global geographic scope/market and is a full-time position. The physical requirements include being present at work, and travel estimates are infrequent. Ideally, you should have a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science, or related discipline. For the Executive position, a minimum of 3 years of clinical data management experience is required, including working knowledge using clinical data capture tools. For the Sr. Executive position, a minimum of 5 years of clinical data management experience is required, including working knowledge using clinical data capture tools. Experience of leading global clinical studies is preferred.,