Clinical Project Manager

November 18

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ProTrials Research Inc.

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Biotechnology • Pharmaceuticals • Healthcare Insurance

ProTrials Research Inc. is a clinical research organization (CRO) headquartered in the United States, offering a wide range of services to the pharmaceutical, biotechnology, and medical device industries. The company provides quality-driven site management, clinical monitoring, project management, data management, and supportive clinical development services. With a focus on therapeutic areas such as oncology, ophthalmology, central nervous system, infectious diseases, women's health, and medical devices & diagnostics, ProTrials is dedicated to delivering high-quality clinical research. Their services include project management, clinical operations, quality assurance, medical and regulatory support, and they also act as a functional service provider, emphasizing virtual trials and remote monitoring capabilities.

51 - 200 employees

Founded 1996

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Lead all clinical study operations, providing strategic/tactical planning, organization, and direction of study project(s) including but not limited to the oversight of clinical project timelines, reports, budgets, monitoring, site and vendor management, clinical supplies, and data collection • Facilitate and foster positive, productive, and timely communication between sponsor, study team, and other functional groups • Manage and motivate study team while serving as a mentor; mentorship may include identifying skills of the clinical team members and assisting with further professional development • Provide proper financial oversight of study budget, including out of scope tracking, in conjunction with the Client Manager (CM) and ProTrials Finance Department • Collaborate with senior management to provide study updates/progress, resourcing needs, sponsor issues, and health status at regularly scheduled intervals • Drive the development, maintenance, and distribution of project plans based on project-specific requirements, throughout the life of the study (i.e., monitoring plan, communication plan, project management plan, eTMF plan, other plans as applicable) • Manage studies in compliance with GCP, relevant SOPs, regulatory requirements, and project-specific plans • Assess resourcing needs to ensure the study has the appropriate resources for the duration of the project • Actively manage and track study risks (with team and sponsor input for potential obstacles that would delay the project’s progress while appropriately escalating issues • Assess training needs of team members on the therapeutic area, protocol, special procedures/skills, and implement the appropriate training plans • Delegate study team responsibilities and ensure that team members have the necessary tools and resources to effectively perform their role • Monitor and manage the project’s progress and develop timelines with input from relevant stakeholders and sponsor approval; re-assess critical path for study progress and adjust timelines as needed • Oversee activities and deliverables of outside vendors, as requested; ensure communication occurs between outside vendors, the team, and sponsor

🎯 Requirements

• RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CRA experience • Outstanding interpersonal, oral, and written communication skills • Proven effectiveness as a team leader • Prior experience successfully managing multifaceted studies from inception through implementation and completion • Outstanding organizational and time management skills • Experience managing projects in a virtual environment • Demonstrated ability to lead by example and to encourage team members to seek solutions independently • Proficiency in Microsoft Word, Excel, and PowerPoint are required • Experience with MS Project and OneNote a plus

🏖️ Benefits

• Your wellness matters to us – that’s why we provide full medical, dental, and vision insurance options for you and your family. • We know life doesn’t pause for work – we provide flexible PTO so you can take care of what matters, both personally and professionally. • You invest in your future – and so do we. Our 401(k) plan includes a company match to help you reach your financial goals. • At ProTrials, we are committed to your growth. Whether you’re looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward. • We have the best coworkers, if we do say so ourselves.