Sr Clin Data Mgr (DG)
Northern, NJ - Pharmaceutical & Biotech - Remote
Date Posted: 12/21/2022 2:10:42 PM
Senior Clinical Data Manager - Early Clinical Development, Phase I/II
Northern, NJ - Remote
Base salary up to 140K + 12% bonus + stock
Will serve as the DM study lead and point of contact for clinical study teams and external partners, (e.g., external data vendors and CROs) for multiple trials within a given Therapeutic Area (TA). Oversee DM activities across all stages of the trial from study start-up through archiving to achieve data management results within the assigned drug assets and contributes to department-level goals to ensure timely completion within project budget guidelines and adhering to all applicable policies and procedures.
Provide a high level of expertise in data management to support clinical studies. Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status. Supervise the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock. Lead data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA/WHO-DD coding. Support the transfer, locking, and archiving of study databases. Lead scheduling and time constrains across multiple projects. Prepare recommendations for new or improved processes for data management and data flow.
Candidates should have working understanding of all applicable regulations including; 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collection. Must have consistent record of leading clinical studies and clinical study teams in a data processing environment and demonstrate robust knowledge of Data Management processes and industry standard methodologies, drawing from wide-ranging experience to resolve complex issues. Strong problem solving, project management, and presentation skills essential to the role are required. Must possess ability to work effectively with and motivate virtual teams in matrix environment and solid understanding of cross-functional activities. Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with JMP and SAS a plus. To be considered you should have Bachelor degree in Mathematics, Science or a related field, minimum of 5 or more years of clinical data management experience in biotech, pharmaceutical or health related industry is required.
Please contact Darren Gutowski at firstname.lastname@example.org