Leads clinical study operations from inception through completion, overseeing timelines, budgets, monitoring, vendors, clinical supplies, data collection, risks, training, compliance, and project plans. Serves as the primary sponsor and study-team contact, manages and mentors team members, assesses resources, tracks financial performance, and ensures adherence to GCP, SOPs, regulatory requirements, and study objectives.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.
Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.
We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.
ABOUT THE JOB
The Contract Clinical Project Manager (PM) plays a key role in the successful conduct of a clinical trial from inception through implementation and completion. The Contract Clinical Project Manager provides overall coordination and strategic management of a clinical trial, in conjunction with the clinical team and other functional groups. The Contract Clinical Project Manager serves as the primary contact with the sponsor, clinical team, and other functional groups, while effectively delegating and overseeing team members.
The Contract Clinical Project Manager ensures that all study team members are appropriately trained on the study and maintain compliance with GCP, the protocol, other associated documents, scope of work, and other clinical objectives. The Contract Clinical Project Manager serves as an effective team leader who manages and motivates team members using positive and productive methods of communication. The Contract Clinical Project Manager also supports team member mentorship, as needed.
HERE IS WHAT YOU WILL DO:
- 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
HERE IS WHAT YOU BRING TO THE TABLE:
- 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
Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant’s personal information in accordance with its statutory obligations and internal policies and procedures.
Information collected during application completion may be retained for a reasonable period of time and in accordance with the company’s established retention policies. Applicants seeking more information may contact [email protected].
ProTrials is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.
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