Description

Calsoft Labs Inc., dba ACL Digital, King of Prussia, PA (Multiple) Sr. Clinical Data Managers needed. Job duties include but are not limited to serving as the DM study lead and the primary point of contact for clinical study teams and external partners, for multiple trials within a given TA; leading all aspects of all DM activities across all stages of the trial study lifecycle; tracking milestones/deliverables to include escalations, and providing clear 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. This role interacts cross-functionally and collaborates w/data management peers and other cross functional stakeholders to define and develop operational type of reports to assist with data exploration and metrics and performing & documenting the oversight of CRO data management activities for assigned studies. Data Management Plan (includes: Data Review, Reconciliation and Cleaning, Coding, SAE Recon, Local Lab Handling activities for CRF and non-CRF data. Lead data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding, continuous process improvement; leading & supporting data t/fs, and ensures eTMF documentation is maintained and performs quality review and inspection readiness to meet IRR compliance. This roles requires a masters in Health Admin, Pharmacy, or related discipline and 24 months exp. Email resumes to: hr.us@acldigital.com and ref jo#22289535