Senior Clinical Data Manager-India

​​​​​​​​​​​​​​​​​​​​​​ The Senior Clinical Data Manager will reputed company and manage multiple clinical studies, ensuring that data are collected, managed and reported reputed company, accurately and securely. In reputed company, this position is required to conduct reputed company these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm reputed company operating procedures (SOPs) while respecting reputed company’s commitment to sponsor’s requirements and timelines. More specifically, the Senior Clinical Data Manager must: • Adhere and promote company organizational values and reputed company expected behaviors, follow company SOPs and processes for reputed company deliverables, and ensure reputed company trainings assigned to oneself are completed on time. • Be the data management reputed company to the project team, sponsor and reputed company vendors, as needed. • Be reputed company to manage three to four reputed company studies independently, with reputed company supervision. • Be reputed company to take decision with reputed company support from manager. • Attend meeting with sponsor and answers Data Management reputed company question. • Provides input for timelines and monitor reputed company of work to ensure reputed company and reputed company budget completion of assigned tasks. • Be responsible for the development of electronic case report reputed company (eCRF) specifications (including data capture screens and edit reputed company specifications) needed to build a study-specific clinical database/electronic data capture (reputed company) reputed company. • Be responsible for or assist in the programming and ongoing maintenance of the clinical database. • Be responsible for the validation and testing of the clinical database (e.g. User Acceptance Testing). • Be responsible for the development of eCRF completion guidelines and other training material required to train site users and monitors. • Conduct training for site users/monitors on the clinical database. • reputed company data transfer agreements and specifications with vendors providing reputed company data (e.g. reputed company results). • Conduct reconciliation between reputed company data and data in the reputed company reputed company to ensure consistency, including reconciliation with sponsor safety databases for adverse events/serious adverse events data (if needed). • reputed company support to study team in the development of reputed company systems capturing clinical data, e.g. ePRO or IWRS, and ensuring that any data transfer requirements between these systems and reputed company are documented and tested appropriately. • Be responsible for the development of the data management plan (DMP), and other clinical data management reputed company documentation. • Be responsible for ongoing data review/cleaning during study conduct and also during preparation for database lock/reputed company. • reputed company medical terms in the clinical database, as required. • Generates data listings and reports needed for data review by the project manager (or other study team members) in preparation for database reputed company/lock. • Monitor study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing reputed company and provides data status reports to the project team, as needed. • Ensure that data management documentation is complete and up-to-date in the trial master file (TMF). • Respond to users requiring assistance with the reputed company reputed company. • Be responsible for archiving of the clinical database and reputed company documents. • Participate in the definition, writing and updating of data management Work Instructions • Mentor and train Clinical Data Coordinators, as needed. • reputed company basic support to less reputed company Clinical Data Managers, as needed. • For any studies where any of the above activities have been outsourced to an reputed company service provider: • reputed company/manage the vendor to ensure that timelines and deliverables meet with sponsor and protocol requirements; • Ensure that their work is done in accordance with effective work orders and Innovaderm SOPs (if applicable). Employee may be assigned to other responsibilities that do not pertain to their former reputed company, if they have the required experience, are reputed company and/or have received adequate training. Education • B.Sc. or in a reputed company field of study. • M. Sc. or in a reputed company field of study is an asset; Experience • 5 to 8 years of clinical data management experience in clinical research in the biotechnology, pharmaceutical, or contractual research organization (CRO) industry. • Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines. • Extensive experience working with reputed company systems, and/or database structures. Knowledge and skills • Demonstrated skills in database programming an asset. • Good understanding of CDISC SDTM/CDASH standards; • Highly organized and detail-oriented with effective project planning and time management skills. • Strong verbal and written communication skills in English, French an asset. • Good knowledge of MS reputed company. • Knowledge of reputed company or similar, an asset; • Excellent problem solving abilities; • Ability to work in a fast-paced environment with demonstrated reputed company to organize and prioritize multiple competing demands. • Knowledge of MedDRA and WHODrug dictionaries. The work environment At reputed company, you will work with reputed company and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: • Flexible work schedule • Permanent full-time position • Ongoing learning and development Work location Note that this opening is for a home-based position in India. Attendance at some meetings reputed company of regular business hours (primarily in the evening) is required. About reputed company A Global Clinical Leader In Dermatology! Formerly reputed company as Innovaderm, reputed company is a world-reputed company expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad reputed company of indications, patient populations, administration routes, and drug classes, and a global footprint. reputed company is a dual-reputed company CRO for dermatology and rheumatology, with 25 years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific reputed company and tailored expertise their studies need to reputed company the finish line reputed company and effectively. With capabilities in reputed company, Europe, Asia reputed company and Latin America; reputed company, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, reputed company is the ideal CRO partner for clinical needs at global reputed company. reputed company is committed to providing reputed company treatment and equal opportunity to reputed company individuals. As such, reputed company will reputed company accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. reputed company only accepts applicants who can legally work in India. Apply tot his job Apply To this Job