Primary Responsibilities :
- Provide oversight to Clinical Data Management Contract Research Organizations (CROs) / vendors for assigned trials to ensure timely delivery of data deliverables and data quality for analysis and reporting in accordance with Enanta’s Standard Operations Procedures (SOPs) and International Conference on Harmonization (ICH) / Good Clinical Practice (GCP) guidance.
- Serve as Lead Clinical Data Manager for assigned studies, attending internal and CRO / vendor study team meetings.
- Ensure quality data collection, review / cleaning, coding, and delivery within agreed timelines through, but not limited to, tracking of study metrics, internal Canonical Data Model (CDM) data reviews and cross functional data reviews.
- Assess study status and metrics and provide feedback on Key Performance Indicators (KPI) for individual studies to respective teams and management.
- Independently lead and oversee the execution of clinical data management activities for multiple and more complex clinical trials per regulatory and industry standards.
- Be responsible for program-level data deliverables and department process initiatives.
- Provide data management technical expertise to trial teams.
- Ensure clinical data is reviewed by sponsor study team to support statistical review, interim review, and or final database lock.
- Oversee development and review of Case Report Forms (eCRFs), Data Management Plan, Validation Specifications, Data Transfer Specifications.
- Responsible for User Acceptance Testing (UAT) of Electronic Data Capture (EDC) and assisting study teams conducting UAT for other data collection methods (ediaries, Interactive Response Technology (IRT)) as required.
- Assist in development of Clinical Data Management (DM) study budgets; support efforts to review study vendor budgets and budget forecast as needed.
- Act as a functional representative to support the development of Program and CDM best working practices / SOPs.
- Mentor junior team members to assist with achieving study deliverables and implementing best practices.
- Telecommuting permitted 2 days per week.
Qualifications :
- Bachelor’s degree in Pharmacy or related field.
- Minimum of 6 years of experience in clinical data management in pharmaceutical or biotechnology industries.
- Experience working in an outsourced data management model and possession of strong skills in managing vendors for clinical data management activities.
- Proficient in multiple EDC platforms including RAVE and related processes from study start to study closure.
- Familiar with implementation of CDASH / SDTM CDISC standards.
- Ability to create and / or implement Enanta data standards for oversight of study startup, data collection and cleaning of third-party data.
- Conversant on medical terminology.
Work Location : Watertown, MA
40 hours / wk.
LI-DNI
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