Job Description
Job Description: Under limited supervision, works collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions are performed in compliance with regulations and according to study protocol and Study Data Management Manual (DMM). Works with involved parties to assure that DMM is prepared according to company SOP's and in compliance with company's data standards. Leads and performs clinical data management activities for assigned studies in accordance with company's SOP's and policies and practices.
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 fulfil 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.
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