CRA Line Manager

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Clinical Line Manager position is responsible for the oversight, planning, initiation, and execution of Clinical monitoring programs.

Essential Functions

• Provides support to study teams in resourcing CRAs and other clinical operations staff, as appropriate, for planned and ongoing clinical trials.
• Supervises and assists with clinical monitoring study teams’ assignments and workload.
• Monitors performance of CRAs and other clinical operations staff, as appropriate, on a continuous basis including, but not limited to, clinical monitoring plan compliance, trip report turnaround metrics, quality of the trip report, action item management, query management, data currency, and TMF management.
• Manages site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites.
• May conduct, attend, or support co-monitoring visits and/or other training, as needed or as necessary to evaluate CRAs.
• May be assigned to study team or other projects based on program/company needs.
• Assists with the development of study/program plans, (e.g., Monitoring Plan, eCRF Completion Guidelines, etc.) as needed.
• Implements individual development and provides coaching and mentoring to monitoring personnel.
• Lead and author training programs for monitoring operations teams.
• Proposes proactive, innovative ideas to help resolve challenges faced by the monitoring teams.
• Establishes regular lines of communication with Clinical Leads, Project Managers, and additional internal and external stakeholders to manage CRA clinical delivery and report/escalate issues to Clinical Operations.
• Assures monitoring teams are performing activities in compliance with good clinical practices (GCP) and in accordance with the regulatory agency requirements, and ICH guidelines.
• Assumes leadership role to ensure the monitoring of clinical operations milestones and timelines are achieved.
• In conjunction with the Clinical Operations leadership, leads monitoring operations, quality, and process improvement initiatives as assigned.
• Other duties as assigned.

Necessary Skills and Abilities

• Excellent verbal and written communication skills; interpersonal and presentation skills are required.
• Extensive understanding of SOPs, Works Instructions, regional regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Effective communication, interpersonal, and leadership skills with the ability to partner with cross functional internal and external stakeholders.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using work instructions and procedures.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.

Qualifications

• Bachelor’s degree desired, but not required, preferably in life sciences, nursing, or a related discipline.
• Minimum 8 years of experience working in clinical research. Minimum 4 years of experience in a monitoring leadership capacity including direct report management.
• Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations.
• Experience working in CTMS, EDC, IVRS, and eTMF systems.
• Experience managing/mentoring and developing junior staff.
• Demonstrated experience in change management initiatives.