3 Ichgcp Guidelines Jobs

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 in the Chennai location. The Senior Clinical Data Manager I (SrCDM1) will be responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, your key tasks will include leading and serving as the primary contact for DM with all relevant parties both internally and externally, planning and projecting the resources required, monitoring tasks against budgets and forecasts, and developing, reviewing, and maintaining project-specific DM documents. You will also lead and coordinate the development of clinical study database set-up, participate in the review of study documents, coordinate database User Acceptance Testing (UAT), create training materials for EDC users, oversee data cleaning and validation, and manage various data transfers and reconciliation activities. Additionally, you will provide project metric reports, status updates, study progress, and feedback to the project team, organize and lead Quality Review activities during the study, assist in project-related contracts negotiation, and manage the database maintenance, lock, and close-out processes. You will also participate in conference calls and meetings with vendors and sponsors, maintain DM study documentation, support internal and external audits, align data management and clinical programming best practices, and provide leadership and support to other department members. To be successful in this role, you should possess a life science or healthcare degree, a minimum of 5 years of relevant work experience as a Clinical Data Manager, thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and experience with electronic data capture software systems. You should also have experience as a DM lead on several studies, strong written and verbal communication skills, strong project management skills, and the ability to simplify complex issues into understandable concepts. Benefits of working at Allucent include a comprehensive benefits package, competitive salaries, departmental study/training budget, flexible working hours, opportunity for remote/office-based working, leadership and mentoring opportunities, internal growth opportunities, access to online training, eligibility for Spot Bonus Award Program, and eligibility for Loyalty Award Program. Please note that office-based employees are required to work in-office for a minimum number of days per work week. Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.,

The Lead Biostatistician is a key member of the Department of Biostatistics & Programming, responsible for performing all Biostatistics tasks essential for clinical trial analysis and reporting. Collaborating closely with the Statistical Programming, Data Management, and Product Development departments, this position involves leading projects across studies or programs. As the primary contact with the sponsor for all biostatistics related activities on assigned projects, you will direct the activities of other biostatisticians to ensure timely completion of high-quality work. Your responsibilities include providing statistical support for clinical studies, developing and reviewing statistical analysis plans, monitoring statistical analysis programs, and collaborating with functional management to meet project deliverables and timelines. In addition, you will perform all SAS programming required for analysis and reporting, plan and execute SAS programs to analyze clinical trial data, and conduct quality control checks on assigned tasks. Your role also involves maintaining high productivity on projects, identifying and communicating resource and quality issues, resolving data interpretation and reporting issues, complying with regulatory requirements, and independently solving technical problems. To qualify for this position, you should hold a minimum of a master's degree in Statistics and have at least 8 years of experience as a Biostatistician and Statistical Programmer for all clinical trial phases. Proficiency in industry standards, CDISC data standards, ICH-GCP guidelines, medical terminology, and clinical trial methodologies is essential for success in this role.,

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients" lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity. We aim to be the Clinical Research Organization that delivers excellence to our clients and patients at every touchpoint, aspiring to be the partner of choice in drug development. If you share our vision and are as driven as we are, join us. You'll be working in a dynamic and supportive environment with some of the brightest and friendliest people in the sector, helping to shape an industry. As a Due Diligence Specialist, you will be responsible for performing extensive Due Diligence/Compliance Checks on all potential Investigators for Site ID I SSU according to ICON and Sponsor specific procedures. Your role will involve updating appropriate documentation and the ICON investigator database with all relevant information. Some key responsibilities include: - Conducting Freedom of Information (FOi) Check and World Check, ECAC (Ethics Compliance Accreditation Certificate) updates - Updating information and study teams feedback from the Quality Assurance department on Investigators with critical findings - Assisting with various queries related to Due Diligence information in the database - Running reports/searches from the system as requested - Ensuring all internal and external customers receive the appropriate level of service and response from the due diligence team - Actively participating in data analysis projects and initiatives - Networking and collaborating with other professionals, attending and presenting at meetings both internally and externally - Undertaking other duties as assigned from time to time To be successful in this role, you will need: - Previous monitoring experience in medium-sized studies, including study start-up and close-out - Knowledge of ICH-GCP guidelines and the ability to review and evaluate medical data - Ability to work effectively to tight deadlines Benefits of Working in ICON: We prioritize building a culture that rewards high performance and nurtures talent. We offer competitive salary packages benchmarked regularly against competitors, annual bonuses reflecting performance goals, health-related benefits for employees and their families, competitive retirement plans, life assurance, and more. You'll benefit from an environment where you are encouraged to fulfill your sense of purpose and drive lasting change. If you require a reasonable accommodation due to a medical condition or disability during any part of the application process or to perform the essential functions of a position, please let us know through the form provided.,