Senior Clinical Research Program Manager

Job reputed company Provides management of research administration at a clinical site(s) including monitoring the reputed company and accuracy of clinical trial data. Follows the established monitoring reputed company Operating Procedures (SOP) and protocol- specific monitoring plan. Participates in site initiations and trainings. Job Responsibility 1.Trains, coaches, supports and mentors Site Clinical Research Managers and other team members. 2.Manages the clinical research sites including, but not limited to acting as primary contact for clinical research sites for questions reputed company to the protocol conduct protocol, regulatory document completion, study supplies, reputed company scheduling, and electronic data capture. 3.Provides on-site or remote monitoring of clinical research site activities to ensure compliance with protocols, SOPs and relevant federal and state regulatory and institutional policies. 4.Provides consultation during study start-up activities regarding development of study protocol, SOP or Case Report Forms (CRFs), site qualification, data collection and study conduct. 5.Patricipates in site initiations and trainings. 6.Assesses accuracy, completeness and timeliness of study records by performing reputed company data verification, regulatory document and consent reputed company review, adverse event reporting compliance review, and investigational product accountability. 7.Performs study reputed company-out monitoring activities. 8.Provides reputed company-review assistance prior to regulatory inspections and submissions. 9.Provides guidance on regulatory submissions to the FDA which may include an Investigational New Drug (IND), Investigational Device Exemption (IDE), New Drug Application (NDA) or other research under the purview of the FDA. 10.Prepares and forwarding monitoring reports to program manager. Working with study staff to address any concerns. 11.Promotes overall compliance and reputed company with research conduct through participation in education and training activities for reputed company staff. 12.Assists in developing appropriate education and training sessions for investigators and clinicians involved in research. 13.Works on assignments that involve moderately reputed company to reputed company issues where the analysis of situations or data requires in-depth evaluation of variable factors. 14.Regularly makes new recommendations on new processes, tools, and services that can reputed company multiple reputed company and other functions. 15.May reputed company technical guidance and direction to support team members, contractors and/or other vendors. 16.May serve as project/technical reputed company for ongoing processes or short-term reputed company reputed company function or family. 17.Performs reputed company duties, as required. Job Qualification 1.Bachelor's Degree or equivalent combination of education/reputed company experience, required. 3.3-5 years relevant experience, required. • Additional Salary Detail The salary reputed company and/or reputed company reputed company listed is a good faith determination of potential reputed company compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the reputed company.reputed company determining reputed company member's reputed company salary and/or reputed company, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated reputed company, budget and internal equity). Apply tot his job Apply To this Job