Our Client, a Biopharmaceutical company, is looking for a Clinical Data Manager for their Remote location. Responsibilities: Project level coordination and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines. Ensure that quality control checks are occurring such that quality databases are delivered and batch cleaning SLAs are conducted as per contract. Review and approve study specific training and lead vendor results and relationship at the study level. Communication of project level issues including processes, timelines, resourcing, performance, etc. Review of all study level non-DM documents for awareness and project level consistency. Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level. Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM. Requirements: Doctorate Degree Or Master's Degree and 2 years of clinical experience Or Bachelor's Degree and 4 years of clinical experience Or Associate's degree and 8 years of clinical experience Or High school diploma/GED and 10 years of clinical experience Degree in life science, computer science, business administration or related field. Clinical Data, Project and Planning Management experience in the Pharmaceutical or Biotech industry. Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc). Knowledge of relevant therapeutic or product area Clinical research experience obtained working on industry-sponsored global clinical trials Excellent oral and written communication skills Proven ability to lead, manage, and motivate others in a complex, multi-functional environment Experience working in a global, matrix organization on global clinical development programs Knowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert advice Broad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines Solid understanding of Biopharmaceutical/Healthcare Compliance Proven ability to anticipate and resolve problems Excellent interpersonal and organizational skills Professional collaboration and leadership skills Experience anticipating and resolving problems Experience writing and presenting clearly on scientific and clinical issues Experience collaborating and leading cross-functional teams Team leadership Strong written and oral communication Flexibility Initiative Problem solving Project management People management Decision making Scientific/technical excellence Why Should You Apply? Health Benefits Referral Program Excellent growth and advancement opportunities As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws. #J-18808-Ljbffr ICONMA
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