Clinical Operations Manager / Clinical Ops Manager
Sterling Life Sciences - Newark, NJ

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1) Manage clinical research projects from participation in the clinical development planning through the execution and managing of clinical trials, identifying and assessing clinical study sites, data collection and interpretation and reporting of results2) Manage CRO activities, including the development of clinical protocols, monitoring clinical trials, data collection and reporting activities3) Evaluate and analyze clinical data, and travel to field sites to supervise and coordinate clinical studies4) Collect and review regulatory documents (CV, IRB approval, licenses, Financial Disclosure, Confidentiality Agreement, etc.)5) Supervise and conduct clinical monitoring visits6) Review and assess monitoring reports, enrollment by clinic and overall adverse events, especially serious adverse events7) Review data listings for all efficacy and safety endpoints, liaison activities between sponsor and vendors as well as clinical reports and documents8) Interact with external CROs and consultants and the company's Product Development, Quality Assurance/Control, Regulatory and Manufacturing to coordinate the successful execution of the company's clinical development program9) Maintain internal liaison between Regulatory Affairs, Data Management and Statistics, Manufacturing, Marketing/Business Development and Clinical Affairs10) Create and maintain drug and non-drug supplies for clinical trials, presenting official documentation to RA for clinic drug shipment approval11) Create/review data queries generated by Data Management, monitors or clinics and assist in writing clinical protocols, study reports and publications12) Collaborate with Finance Department and assist in developing budgets and monitors, reports on and projects expenditures for internal and external resources for clinical trials13) Update and maintain clinical trial records and documents14) Track and maintain non-drug supplies to clinics15) Track/file clinic and study documents16) Receive, track, file and distribute CRFs, monitor reports, and regulatory documents (1572, protocol, IC, FD, cover letter, mailing or electronically)17) Manage clinical close-out communications/tasks18) Archive all study documents19) Assist Clinical Operations Project Management staff with tracking invoices and payments to vendors/sites20) Coordinate and perform administrative tasks associated with the inception of new clinical studies/agreements and investigator and FDA meetings21) Mail initial investigator interest/participation letters22) Create, distribute, collect and file Confidentiality Disclosure agreements23) Complete template (study specific), printing, mailing and track return receipt of CTA24) Expedite CTA for in-house review and signatures25) Distribute and copy CTA (Original to legal & site and copies to accounting and clinical files)26) Coordinate logistics associated with scheduling and conducting investigators, regulatory and FDA meetings such as hotel/travel arrangements, copying presentations, distributing of ancillary supplies to meeting planner and mailing of any follow-up information/responses from the investigator's meeting27) Assist in developing proposals, recommendations and presentations relative to the identification and implementation of clinical development program strategies, and protocolsTAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility
1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)3) Recent experience in the medical device/pharmaceutical industry is strongly preferred4) Preference will be given to people who have recent experience in clinical operations management