We opened our doors with a clear and simple vision: to provide the worldwide clinical research industry with professional services that demonstrate the highest level of experience, quality, and integrity. Since 1996, ProTrials has supported research that has led to ground-breaking treatments and solutions in the pharmaceutical, biotechnology, and medical device industries.
What fuels our focus? Most of us entered the clinical research field to help patients, caregivers, or maybe even our loved ones. We show up every day committed to do work that matters. When you join ProTrials, you will join a collaborative community helping to build a healthier world.
We also understand your need to balance a meaningful workload with life’s every-day moments. At ProTrials, we know that this makes our employees happier, healthier, and more successful.
SUMMARY
The Clinical Project Manager (Clinical PM) plays a key role in the successful conduct of a clinical trial from inception through implementation and completion. The Clinical PM provides overall coordination and strategic management of a clinical trial, in conjunction with the clinical team and other functional groups. The 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 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 Clinical PM serves as an effective team leader who manages and motivates team members using positive and productive methods of communication. The Clinical Project Manager also supports team member mentorship, as needed.
ESSENTIAL DUTIESLead 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 collectionFacilitate and foster positive, productive, and timely communication between Sponsor, study team, and other functional groupsManage and motivate study team while serving as a mentor. Mentorship may include identifying skills of the clinical team members and assisting with further professional developmentProvide proper financial oversight of study budget, including out of scope tracking, in conjunction with the Client Manager (CM) and ProTrials Finance DepartmentCollaborate with senior management to provide study updates/progress, resourcing needs, sponsor issues, and health status at regularly scheduled intervals (Project Review)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 plansAssess resourcing needs to ensure the study has the appropriate resources for the duration of the projectActively manage and track study risks (with team and Sponsor input for potential obstacles that would delay the project’s progress while appropriately escalating issuesAssess training needs of team members on the therapeutic area, protocol, special procedures/skills, and implement the appropriate training plansDelegate study team responsibilities and ensure that team members have the necessary tools and resources to effectively perform their roleMonitor 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 neededOversee activities and deliverables of outside vendors, as requested; ensure communication occurs between outside vendors, the team, and sponsorOTHER QUALIFICATIONSOutstanding interpersonal, oral, and written communication skillsProven effectiveness as a team leaderPrior experience successfully managing multifaceted studies from inception through implementation and completionOutstanding organizational and time management skillsExperience managing projects in a virtual environmentDemonstrated ability to lead by example and to encourage team members to seek solutions independentlyComputer proficiency in Microsoft Word, Excel, and PowerPoint are requiredExperience with MS Project and OneNote a plusEDUCATION AND/OR EXPERIENCERN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CRA experiencePERKS AND BENEFITSCompetitive payCareer growthFull medical, dental, and vision benefit packages401(k) with matchCommuter benefitsLegal benefitsThe best coworkers, if we do say so ourselvesExcept 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
HR@ProTrials.com.
ProTrials Research, Inc. is an equal opportunity employer. ProTrials does not discriminate against qualified applicants or employees with respect to any terms or conditions of employment based on 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.
