The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
A Pharmaceutical Company is seeking a Remote Oncology Device CPM
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.
• 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 company’s Finance Department
• Collaborate 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 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
Skills & Requirements
• 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
• Computer proficiency in Microsoft Word, Excel, and PowerPoint are required
• Experience with MS Project and OneNote a plus
EDUCATION AND/OR EXPERIENCE
• 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
• Solid Oncology and/or Medical Device Experience in a Project Management capacity\
• RN or Bachelor’s degree
• Must have prior CRO experience; would be great if this person had previous experience as a CRA
• Will not consider candidates with jumpy backgrounds or more traditional "contracting" backgrounds
• Previous experience leading the direction of the study through project timelines, reports, budgets, monitoring, site and vendor management, clinical supplies and data collection
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570
Drug testing may be required; please contact a recruiter for more information. #1143141