Clinical Trial Manager
Come Join the DCN Dx team!
As Clinical Trial Manager, you will work with our clients to deliver clinical research support, from initial clinical and regulatory strategy through to the final clinical study report. Ideally, you'll have over 7 years of experience working in clinical research, clinical affairs or clinical operations, with significant IVD experience. This position will be remote, part-time (50%) reporting to the Vice President of Clinical Research.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work with the Clinical Research team to oversee clinical sites and manage clinical trials on behalf of DCN Dx clients.Write clinical trial-specific documents including but not limited to: protocols, case report forms, case report form completion guidelines, monitoring plan, source worksheets, specimen management plans and Study Manual of OperationsLead identification, qualification, initiation, monitoring and closeout of clinical trial sitesManage inventory of investigational product and ensure sites are properly suppliedReview clinical data for accuracy and raise queries as neededWork with Data Management and Biostatistics to ensure timely receipt, review and completion of data for clinical databasesManage, track, and report all protocol deviations Perform other tasks and duties as assigned.Develop SOPs for Clinical ResearchEffectively utilizes external resources to meet project objectives.Demonstrates and advocates the DCN Dx Culture of customer service and excellence.Travel
Ability to travel up to 50%.
Required Education and Experience
BS or BA in biology or biochemistry or a related field or BS/BA in another field with at least 10 years of experience in Clinical Research7+ years of experience managing clinical trials, IVD experience preferredStrong understanding of GCP/ICH requirements, with an emphasis on US clinical trials managementStrong consulting skills, excellent oral and written communications and interpersonal skills. Ability to work in teams is critical. Basic knowledge of MS Office products and familiarity with data collection tools a must.Knowledge and Skills
FDA regulations, GMP/GLP/GCP & Lean ManufacturingFull proficiency with various laboratory techniques/instrumentsThorough knowledge of applicable safety and standards guidelines, such as FDA, SOP, cGMP, regulations, and/or MSDSDemonstrated competence in conducting chemical analysesStrong knowledge of wet chemistry techniquesAbility to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information.Strong verbal and written communication skills as well as good computer skillsEstablish and maintain cooperative working relationships with others.Benefits
Medical, Dental, VisionLife/AD&D, Short-Term Disability, Long-Term DisabilityPaid Time Off, Holiday Pay, Maternity/Paternity Leave401k, 3% ContributionAmazing Colleagues and CultureAAP/EEO Statement
DCN Diagnostics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
140000.00 To 150000.00 (USD) Annually
