Clinical Trial Lead / Study Manager
Kelly Services is currently seeking a Clinical Trial Lead for a long-term engagement with one of our Global Pharmaceutical clients in Warsaw IN or Raynham MA . This role will be remote working at home until Covid restrictions are lifted.
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
This individual will be responsible for leading one or several clinical trials within the Clinical R&D Operations CoE, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the trial leader for clinical study execution
- Serve as a Senior Clinical Trials Leader within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device Franchises
- Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
- Serves as a member of the clinical trial/study core team and may serve as the liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects under his/her responsibility
- May serve as the primary contact for clinical trial sites
- Solves problems with support from Clinical Management arising during clinical study execution, and will seek guidance for more complex problems, as needed
- Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- May be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed
- Track assigned projects budgets to ensure adherence to business plans
- Support the implementation of new clinical systems/processes, and provide support for publications, as needed.
- Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
- Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
People Leadership Responsibilities:
- Ensure that all Human Resource related activities, and decisions embody the Company Credo Values.
- Provide leadership within a clinical trial, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus.
- Ensure efficient use of resources within the clinical study/program to provide high quality deliverables.
Business Leadership Responsibilities:
- Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials.
- May lead several small/medium clinical trials (regulated and non-regulated) and/or a small number of large non-regulated projects that may involve other clinical operations staff (i.e., >250K USD annual investment).
- May assist with the management of large regulated or complex trials/program under supervision of CTM or Senior CTM.
- Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical trials under his/her responsibilities.
- Reviews and provides feedback on clinical operation section of protocols with supervision.
- May plan budgets for single trials with supervision
- BS degree with at least 4 years, MS with at least 3 years, PhD with at least 1 years of relevant experience preferred.
- Previous experience in clinical trial management or equivalent is required
- Clinical/medical background a plus
- Medical device experience a plus
- Functional and Technical Competencies:
- Requires understanding of Good Clinical Practices
- Understanding and application of regulations and standards applied in clinical areas/regions is required.
- Good presentation skills and effectively influencing of others
- Written and oral communication skills
- Demonstrated competencies in the following areas are required:
- Leadership in a professional and ethical manner
- Technical writing skills
- Leadership Competencies:
- Leadership required in alignment with Company Leadership Imperatives:
- Connect - develop collaborative relationships with key internal and external stakeholders, principally within allocated study teams and department and wherever possible across the CoE as well as the resources providers and vendors to create a strong and productive partnership.
- Shape - Make recommendations for and actively participate in departmental process improvement activities.
- Lead - Take ownership for development of self and engage in transparent and constructive conversations.
- Deliver - Strive to ensure all deliverables on allocated studies and those of any direct reports are met on time, and within budget and in compliance to SOPs and regulations.
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