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Clinical Research Project Manager
2 months ago
Benefits Available
Weekly Pay
$37.50/Hour
Shift(s) required: Day shift ; 8-4 (with ability to flex due to time zones and business need)
Position Summary
The Project Manager (PM) serves as the functional and direct liaison between leadership, physicians, staff and sponsors to ensure successful completion of all deliverables for industry sponsored trials (ISTs). The PM should be able to correctly identify and prioritize issues in matter of urgency and identify who is most capable of doing tasks within a complex multi-project environment. The PM ensures that all clinical tasks meet client and Research Institute expectations and are completed in accordance with the contract, protocol, ICH-GCP guidelines and applicable Standard Operating Procedures (SOPs). Provide leadership and expertise to ensure successful execution of site selection, study operations, and management of clinical deliverables.
Major Responsibilities:
Duties include but are not limited to:
Leads the planning, execution, and oversight of multi-site, multi-stakeholder clinical trials
Manages project timelines to ensure that project goals and deliverables (including reports, study subject recruitment) are met on time.
Tracks the execution of projects against project timelines and communicates project status to internal and external collaborators.
Oversees project activities assigned to research personnel and works closely with operations team to develop and implement strategies to achieve project objectives, improve efficiency of research processes and procedures (including recruitment), and subsequently execute improvements, working with leaders as appropriate.
Develop or supervise the development of all plans and tracking tools used for managing and reporting of study status; Provide study status reports, as needed.
Manages active study portfolio, meetings, and agendas for site operations teams working with clinical and research leaders, investigators, clinical staff, other internal stakeholders (IT, Legal, Finance), and external collaborators.
Lead study team meetings, ensuring minutes are taken and distributed appropriated, and that action items are documented and resolved in a timely manner.
Independently builds relationships with research teams and collaborating sites
Train or ensure the appropriate training of site staff and study teams; Ensure all training is appropriately documented.
Manage vendors and vendor contracts as needed.
Initiate improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects, as needed.
Create a variety of reports, documents, training tools, and correspondence as needed to assist participating trial sites and for internal purposes in the ongoing monitoring and evaluation of the projects progress.
Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management.
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Education & Experience:
Bachelor’s Degree
Required
1+ years of clinical research experience
Required
3+ years of clinical research experience
Preferred
1+ years of project management experience
Required
Or equivalent combination of education and/or experience
Licenses, Certifications, & Training:
PMP or ACRP-PM
Preferred
Knowledge, Skills, Abilities, Behaviors:
Knowledge:
Knowledge of FDA guidelines and GCP is required
Strong understanding of clinical trials, study design, ICH/GCP knowledge and training
Skills:
Skilled in identifying opportunities to improve efficiency of research processes and procedures and subsequently execute improvement.
Experience in project management and ability to drive progress in complex, multi-stakeholder initiatives.
Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines.
Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, proficient in Microsoft Office software, including Word and Excel, and ability to learn new software, if required
Comfortable with setting up and managing committee meetings.
Abilities:
Excellent organizational and prioritizing capabilities
Resourceful with heightened analytical abilities and problem solving skills in a fast paced environment
Excellent interpersonal skills, detail-oriented and meticulous
Action oriented.
Ability to meet deadlines
Travel Required
Check the frequency of travel required of the employee to perform the essential functions of the job.
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No Travel: The job does not require any travel.
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Occasional Travel: The job may require travel from time- to-time, but not on a regular basis.
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The job may require up to 25% travel.
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The job may require up to 50% travel.
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The job may require up to 75% travel.
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The job may require 76% or more travel.
Health Requirements: None, candidate will be working corporate location or remote #ZR
