Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.Job DescriptionJob Description:Single Point of Contact to the Therapeutic Areas (TA)/Clinical Trial Team for TMF related questions and serves as Subject Matter Expert on TMF Quality ControlMaintain documentation of appropriate oversight of all external partner’s work specific to document management within the TMFResponsible for optimizing, maintaining, and rolling out TMF Quality Control training mechanismsTranslate trial information, processes and regulations into TMF documentationResponsible for conducting specified quality controls on some essential clinical documents according to established processesTrack progress to key quality indicators (KQIs)s, and overall compliance to TMF processes and regulationsOversight of TMF QC Specialists and monitor QC performed by the TMF QC specialists on assigned trialsProvide training/mentoring to the TMF QC Specialists on TMF processes, reconciliation/QCMaintain documentation of appropriate oversight Of Vendor TMF Technical Quality Control Personnel specific to document management QC within the TMFSingle Point of Contact to the CTT for their assigned trialsProvide CTT with TMF QC reports and assist with TMF related questions (e.g. TMF Table Of Content)Accountable for performing data analytics, identifying data issues / concerns, and facilitating the CTT in solving and implementing systemic solutionsProactively “pull” information during the set-up, execution, and close-out phases from accountable CTT members.Participate in CTT meetings as needed, responsible for the training of CTTs on TMF and implementation of best practices within CTTsMonitor the CTT compliance with TMF process within a trial in a timely mannerAccountable for generating and managing the TMF Filing plan and TMF QC ReportsContact point to secure access to eTRAC systemServe as Subject Matter Expert on TMF training materials, processes and tools (eg. Clinical Document Management system, user Manuals for eTRAC)Participate and/or may lead some meetings related to TMF processes and trainings (eg TMF QC Compliance Review Meeting).As a TMF QC Management & Oversight representative, may participate in global cross-functional business process performance or clinical development improvement initiatives.Participate in the on-boarding, mentoring and training of new staff.Experience in cross-functional, multicultural and international clinical trial teams; able to work independently.Ability to lead globally distributed matrixed teamsGood knowledge of clinical development process, regulatory requirements and GCP. Client experience in these areas is preferred.Excellent understanding of system data structures and Clinical Document Management System functionalityAbility to learn new systems readilyStrong computer skills (EXCEL, MS Word) requiredExcellent attention to accuracy and detailsExcellent communication, organization and tracking skills.Strong operational skills and demonstrated ability to meet timelines.Proven networking skills and ability to train colleagues.Education:Bachelor’s degree in life science/healthcare is required with minimum 4 years’ experience in clinical operations and / or clinical systems management orAssociate degree required with minimum 6 years’ experience in clinical operations and / or clinical systems managementAdditional InformationAll your information will be kept confidential according to EEO guidelines.