Clinical Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee all clinical study operations, delivering strategic and tactical planning, organization, and direction for study projects, which encompass oversight of clinical project timelines, reports, budgets, monitoring, site and vendor management, clinical supplies, and data gathering.

• Promote and cultivate effective, constructive, and timely communication among sponsors, study teams, and other functional groups.

• Lead and inspire the study team while acting as a mentor; this mentorship may include recognizing the strengths of clinical team members and aiding in their professional development.

• Ensure proper financial management of the study budget, including tracking out-of-scope expenses, in collaboration with the Client Manager (CM) and ProTrials Finance Department.

• Work alongside senior management to provide updates on study progress, resource requirements, sponsor concerns, and health status during regularly scheduled meetings.

• Spearhead the creation, maintenance, and distribution of project plans tailored to project-specific requirements throughout the study's lifecycle (e.g., monitoring plan, communication plan, project management plan, eTMF plan, and other relevant plans).

• Administer studies in accordance with GCP, applicable SOPs, regulatory mandates, and project-specific plans.

• Evaluate resource needs to guarantee that the study is equipped with the right resources for the project's duration.

• Proactively manage and monitor study risks, incorporating feedback from the team and sponsor regarding potential obstacles that may impede project progress, while appropriately escalating issues.

• Identify training needs for team members concerning the therapeutic area, protocol, special procedures/skills, and implement suitable training plans.

• Assign study team responsibilities and ensure that team members possess the necessary tools and resources to effectively fulfill their roles.

• Track and manage the project’s progress, developing timelines with input from relevant stakeholders and sponsor approval; reassess the critical path for study progress and modify timelines as required.

• Supervise the activities and deliverables of external vendors, as needed; ensure that communication occurs between external vendors, the team, and the sponsor.

⛳️ Requirements

• RN or a Bachelor's and/or advanced degree in biological sciences or a related field, or an equivalent combination of relevant experience, education, or training along with previous CRA experience.

• Exceptional interpersonal, oral, and written communication abilities.

• Proven success as a team leader.

• Prior experience managing complex studies from inception through to implementation and completion successfully.

• Excellent organizational and time management capabilities.

• Experience in managing projects in a virtual environment.

• Demonstrated capacity to lead by example and motivate team members to find solutions independently.

• Proficiency in Microsoft Word, Excel, and PowerPoint is essential.

• Experience with MS Project and OneNote is a plus.

🏝️ Benefits

• Your wellness is important to us – that’s why we offer comprehensive medical, dental, and vision insurance options for you and your family.

• We understand that life doesn’t stop for work – we provide flexible PTO so you can manage what matters most, both personally and professionally.

• You invest in your future – and so do we. Our 401(k) plan includes a company match to support you in achieving your financial goals.

• At ProTrials, we are dedicated to your growth. Whether you are looking to enhance your skills or advance your career, we offer the support and opportunities you need to continue progressing.

• We have the best coworkers, if we do say so ourselves.