Clinical Trial Manager

Clinical Trial ManagerPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.ResponsibilitiesThe Clinical Trial Manager (CTM) works closely with various sponsors, internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, study protocol, company goals, and budgets. The CTM will have the following responsibilities as assigned:Manage the operational aspects of clinical trials (e.g., study management, site monitoring and management, trial master file (TMF) oversight,)Coordinate and support regulatory submissions and notifications (e.g., IND/CTA amendments, annual reports), as applicableSupport the management of the ongoing study budget tracking, forecasting, and reconciliation, for Clinical Operations servicesAssist in Development of and manage the study project plan, including timeline, budget, and resourcesParticipate in protocol, CRF and strategy development, Clinical Study Report (CSR) preparation, NDA submission, as appropriatePrepare metrics and updates for management, as assignedProactively identify potential study issues/risks and recommend/implement solutionsPrepare and/or review/approve study-related documents (e.g., Clinical Monitoring Plan, Laboratory Manual, Patient Diary, Study Operational Guildelines, Pharmacy Manual, Integrate Quality Risk Management Plan and CRF Completion Guidelines)Participate in quality risk assessments and develop Key Performance Indicators (KPIs); including identification of quality issues within the study to implement appropriate corrective action planParticipate in and facilitate vendor selection process for outsourced activitiesReview and approve vendor invoices and assess financial impact of scope changesProvide ongoing oversight of clinical vendor service providers, including performance monitoring, KPI review, issue escalation and corrective active implementationManage clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulationsEnsure inspection readiness for assigned studies, support regulatory authority inspections, internal audits and responses to audit findings in collaboration with Quality Assurance and Regulatory AffairsManage Clinical Trial Associates (CTA) and other study staff, as neededRecommend and implement innovative process ideas to impact clinical trials managementOrganize and manage internal team meetings, investigator meetings and other trial-specific meetingsCollaborate with Pharmacovigilance and Medical Monitoring to ensure timely safety reporting, SAE reconciliation, and operational alignment with safety processes and vendorsPartner with Data Management and Biostatistics to oversee clinical data quality metrics, support data cleaning activities, and ensure study readiness for database lockDevelop site study documents (informed consent template and study tools/worksheets), investigator contracts, and site paymentsManage the feasibility, selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the functionReview and identify trends in enrollment and data entry at sites, and identify solutionsManage drug supply and non-drug supply needs of the studyDevelop and implement departmental Standard Operating Procedures, as necessaryContribute to knowledge sharing and training opportunities within the department and the companyContribute to PROMETRIKA Thought Leadership and marketing campaigns (as necessary)Mentor and trial junior team members and cross-functional team members (as necessary)Represent Clinical Operations at bid defense and capabilities presentationsPerform other duties as requiredEducationBachelor's degree in life sciences, nursing, pharmacy, public health or related field is requiredMaster's degree (e.g., MS, MPH, MBA) or advanced scientific/clinical training is highly valued but not requiredProject Management Professional (PMP)certification is highly valued but not requiredExperienceMinimum of 5 years working in the clinical research/biotech industry with progressive responsibility in clinical trial operationsDemonstrated experience managing multiple studies, sites and vendors, included blinded study experienceHands-on experience with all phase of the project lifecycle include study start-up, maintenance and close-outHands-on experience study and site management, site monitoring oversight, clinical vendor management, clinical trial risk management, TMF management, and regulatory submissions (e.g., CSR, NDA support).Experience working in cross-functional teams and direct involvement in protocol and CRF development is highly valuedProven track record of ensuring GCP/regulatory/protocol compliance, managing timelines and budgets, leading risk assessments, and implementing CAPAs and KPIsSkillsWorking knowledge of the clinical drug development processStrong knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelinesStrong analytical and problem-solving skillsWritten, verbal communication and presentation skills in small and large group settingsMust possess excellent interpersonal skillsMentoring/coachingAbility to effectively multi-task and prioritizeOrganizational skills and attention to detail requiredSolid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel, PowerPointCross functional and cross-cultural awarenessAbility to work in a matrix environment. Must have the ability to build and maintain positive relationships with management, peers, and direct reportsAbility to deal with time demands, incomplete information or unexpected eventsPhysical RequirementsIncumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate's work experience, education/training background and parity with current employees in the same or similar positions.