Clinical Trial Operations Manager Jobs (NOW HIRING)

• 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 applicable
• Support the management of the ongoing study budget tracking, forecasting, and reconciliation, for Clinical Operations services
• Assist in Development of and manage the study project plan, including timeline, budget, and resources
• Participate in protocol, CRF and strategy development, Clinical Study Report (CSR) preparation, NDA submission, as appropriate
• Prepare metrics and updates for management, as assigned
• Proactively identify potential study issues/risks and recommend/implement solutions
• Prepare 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 plan
• Participate in and facilitate vendor selection process for outsourced activities
• Review and approve vendor invoices and assess financial impact of scope changes
• Provide ongoing oversight of clinical vendor service providers, including performance monitoring, KPI review, issue escalation and corrective active implementation
• Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
• Ensure inspection readiness for assigned studies, support regulatory authority inspections, internal audits and responses to audit findings in collaboration with Quality Assurance and Regulatory Affairs
• Manage Clinical Trial Associates (CTA) and other study staff, as needed
• Recommend and implement innovative process ideas to impact clinical trials management
• Organize and manage internal team meetings, investigator meetings and other trial-specific meetings
• Collaborate with Pharmacovigilance and Medical Monitoring to ensure timely safety reporting, SAE reconciliation, and operational alignment with safety processes and vendors
• Partner with Data Management and Biostatistics to oversee clinical data quality metrics, support data cleaning activities, and ensure study readiness for database lock
• Develop site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
• Manage the feasibility, selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• Review and identify trends in enrollment and data entry at sites, and identify solutions
• Manage drug supply and non-drug supply needs of the study
• Develop and implement departmental Standard Operating Procedures, as necessary
• Contribute to knowledge sharing and training opportunities within the department and the company
• Contribute 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 presentations
• Perform other duties as required

• Bachelor’s degree in life sciences, nursing, pharmacy, public health or related field is required
• Master’s degree (e.g., MS, MPH, MBA) or advanced scientific/clinical training is highly valued but not required
• Project Management Professional (PMP)certification is highly valued but not required

• Minimum of 5 years working in the clinical research/biotech industry with progressive responsibility in clinical trial operations
• Demonstrated experience managing multiple studies, sites and vendors, included blinded study experience
• Hands-on experience with all phase of the project lifecycle include study start-up, maintenance and close-out
• Hands-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 valued
• Proven track record of ensuring GCP/regulatory/protocol compliance, managing timelines and budgets, leading risk assessments, and implementing CAPAs and KPIs

• Working knowledge of the clinical drug development process
• Strong knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
• Strong analytical and problem-solving skills
• Written, verbal communication and presentation skills in small and large group settings
• Must possess excellent interpersonal skills
• Mentoring/coaching
• Ability to effectively multi-task and prioritize
• Organizational skills and attention to detail required
• Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint
• Cross functional and cross-cultural awareness
• Ability to work in a matrix environment. Must have the ability to build and maintain positive relationships with management, peers, and direct reports
• Ability to deal with time demands, incomplete information or unexpected events

Physical Requirements