Senior Clinical Data Manager - Katalyst Healthcares & Life Sciences

Responsibilities:

• Serves as primary DM contact for assigned studies, including representation on project teams and working with CRO's performing data management tasks for assigned study.
• Leads and performs clinical data management tasks for assigned studies in accordance with company's SOP's and policies and practices including, not limited to:
• Monitors data clean-up process performed by CRO's from study start-up through data archiving.
• Provides data for analysis
• Manages activities including: medical coding; developing data validation checks and managing database snapshot
• Prepares and distributes project status reports to project team and management.
• Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with company's SOP's.
• Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF.
• Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities.
• Contributes to upkeep company's DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.
• Works with study team and coordinates all data management functions. Manages coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedures.
• Adheres to procedures surrounding retention of data, records, and information for clinical studies
• May fulfill project/program data manager role responsibilities as needed
• May provide Subject Matter Expert Support for select topics assigned

Requirements:

• Bachelor's degree in mathematics, Science or a related field, along with at least 5 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus.
• Years of Experience/Background - 8-10 Years
• Self-directed and comfortable working in teams with the ability to work and operate independently within a tight deadline environment. High degree of creativity, latitude and attention to detail required.
• Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong analytical and project mgmt skills. Strong written and oral communication skills required.
• Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with JMP and SAS a plus.
• May report to Director or Above.