Clinical Trial Manager

PROMETRIKA 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.

RESPONSIBILITIES

The 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 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

EDUCATION

• 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

EXPERIENCE

• 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

SKILLS

• 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

Incumbents 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.