Contract Senior Clinical Trial 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.

Overview of Role:

The Senior Clinical Trial Manager is responsible for all aspects including study start-up and maintenance through study close-out. They provide key oversight, guidance, and support for the operation and execution of clinical trials for clinical programs including overall operational trials(s) planning and implementation, manages program(s) timelines and budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and external vendors. Leads multidisciplinary department initiatives and provides support for process changes to increase efficiency in study execution. Trials include, but are not limited to, rollover (extension) clinical trials, closing and terminating clinical trials, continued access/post-trial access programs, and late-phase post-marketing trials.

Responsibilities:

• Oversee and Deliver Trials(s) on time, within budget, and with highest achievable quality.
• Assist in the review, development and/or writing of clinical trial documents and manuals as needed, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
• Manage the evaluation and selection of investigative sites for applicable clinical trials, responsible for feasibility.
• Select, coordinate, and monitor activities of vendors.
• Develop and manage clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, and confidentiality agreements.
• Support Investigator Agreements (CTAs), CRFs, CRF guidelines, statistical/pharmacokinetics analysis plans, monitoring plans, data management, and safety monitoring.
• Review pre-study, study initiation, monitoring (including interim visits), and close-out reports, and conduct co-monitoring visits, as needed.
• Be responsible for overseeing the maintenance of the TMF, ensuring its completeness at the end of the study, and performing periodic QC.
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices.
• Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring clinical trials for conformation with company SOPs.
• Provide close oversight on the findings of monitoring reports and loop back with broader team to provide updates.
• Promote investigator performance and adherence to protocol, and proactively address conduct issues and enrollment problems, as necessary.
• Anticipate, recognize, and manage issues/risks and recognize the need to seek assistance from or inform senior management.
• Understand when decision-making can occur at the study team level versus when it must be escalated to Senior Management.
• Drive quality-by-design efforts to proactively identify and manage risks to trial quality and ensure study inspection readiness at all times.
• Develop and manage trial(s) timelines, budget and priorities.
• Participate in data review and discrepancy resolution.
• Ensure set up and maintain all systems to plan and implement trials and track progress.
• Generate reports to update management on progress of the clinical trial(s).
• Ensure appropriate clinical trial supply plans are implemented and managed where appropriate.
• Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
• Develop key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
• Perform initial review of CRO and other third-party vendor training on protocols, guidelines, and/or practices.
• Lead multi-disciplinary trial teams, including st