Novartis Healthcare Pvt Ltd Website http://www.novartis.com/
Clinical Data Specialist
Job Description Provide timely and professional ongoing management of project & clinical trial data, Phases I to III, by identifying and resolving errors and inconsistencies in CRF data and by maintaining the CDM Study Workbook to ensure consistently high standard database(s) with respect to cost, quality and timelines. Coordinate serious adverse event reconciliation and monitor listing review with the clinical teams, perform external data reconciliation (e.g. lab data) in order that databases can be declared clean and locked according to strict quality standards. In addition represent CDM in clinical teams, define trial level data management strategy and manage clinical trials.
MAJOR ACCOUNTABILITIES
Coordinate Clinical Data Management (CDM) activities for several protocols and CDM projects. In particular:
• Serve as Project CDC for large projects or multiple smaller projects providing professional Data Management input to global clinical teams.
• Responsible for timelines and quality of the CDC deliverables, including eCRF, EDC database set up and database locks, for the assigned projects and/or trials.
• Maintain clinical trial study workbooks
• Perform database lock preparation activities in time for interim and final database lock
• Generate summary reports and listings for the Clinical Department
• Provide professional CDM input to Clinical Trial Team(s)
• Coordinate trial activities with biostatistician, prorgammers, and clinical team
• Provide CDM training to clinical trial team members, site personnel and external site monitors
• Serve as Project CDC for projects outsourced to CROs
• Complete activities within the time frame of established metrics
• Ensure appropriate tracking systems (e.g. CTMS) are up to date and accurate.
• Adhere to SOPs and guidelines
• Identify problems, analyze them, and suggest solutions
• Assist in authoring, and participate in the review of CDM procedures and guidelines
• Contribute towards and participate on CDM projects
• Author, review and/or execute test plans for CDM programs
Desired Profile
• Good computer skills
• Relational databases
• Customized software packages, preferably the MS Office Suite and ED V systems and/or Clintrial 4
• Good understanding of clinical trial methodology, GCP and medical terminology
• Good interpersonal and communication skills and the ability to operate effectively in an international environment
• Good problem solving skills
• Good presentation skills
• Ability to work under pressure and meet timeline
• Good organizational and time management skills
• Ability to work as part of a team and without close supervision
• Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners
Experience 1 - 5 Years
Education UG - Any Graduate - Any Specialization,Graduation Not Required bPG - Any PG Course - Any Specialization,Post Graduation Not Required
Location Hyderabad / Secunderabad
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