Kelly is currently seeking a Clinical Trial Manager for a long-term engagement with one of our Global Medical Device clients in the In Vitro Diagnostics (IVD) area. This position will be able to work remotely from home office. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 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.
Responsible for the successful planning, implementation and conduct of clinical studies to verify and validate clinical software, instrument platforms, assays and biomarkers developed by the company. Functionally responsible for all clinical study preparation and conduct activities throughout the duration of each assigned clinical trial. Assures clear external/internal team communication, process documentation, and compliance with the company and departmental processes along with Good Clinical Practices and procedures set forth.
Provides leadership in complex clinical research activities including clinical trial programs for assigned area of focus for registrational, non-registrational and/or research studies for US or outside US with moderate supervision.
Responsibilities include reaching an agreement on study goals with other functional areas, coordinating and overseeing study monitors and investigators to ensure compliance, monitoring, analyzing and interpreting study data, and preparing contributing to study reports.
Responsible for the implementation and maintenance of the clinical trial-related policies, as well as processes and procedures related to the Product Development Process.
Works with the project manager to define and manage budgets and timelines for each study and is accountable for delivery of documentation to meet study milestones. Manages investigational site and clinical study documents.
Provide technical expertise on the development of clinical trial documents and records (clinical validation plan, protocols, monitoring plans, manual of operations, investigator training materials, clinical trials report, study forms, templates and monitoring reports, Instructions for Use etc.). Ensures informed consent form is prepared, if applicable
Maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners in meeting business goals and ensures operational excellence. Works with moderate supervision and autonomy.
Acts as liaison with the Clinical and Medical groups within the company and external partners to identify and implement collaborative studies, regulatory activities, and other programs. Oversees site selection activities.
Responsible for adhering to regulations, guidelines and departmental standard operating procedures.
Manages relationships with international opinion leaders, investigators and key customers.
Manages internal and external resources to support scheduled studies.
Oversees all study related activities for complex studies with moderate supervision.
Assess identified potential risks for compliance and data integrity. Serves as the primary point of contact for escalation to the Clinical Operations senior management and then the Project Team.
Represents the department at cross-functional project teams at the Business Unit level.
Implements global study support strategies and initiatives with moderate supervision.
Regularly interacts with executive management on work of area(s) that affect larger organizational goals.
Responsible for assessing processes and establishing plans for improvements with input from senior management.
PEOPLE LEADER RESPONSIBILITIES (if applicable):
Provides effective leadership of direct reports.
Ensures direct reports comply with regulations, SOPs and protocols.
Develops Clinical Research Associates and ensures training, development and qualification.
Provide direction and mentorship to staff including setting goals that align with corporate, functional and project goals.
Positions with people management responsibility have HR responsibility for workforce planning, interviewing, selection decisions, performance management, corrective action, termination decision, compensation decisions, and handling employee concerns or complaints.
May review technical deliverables of direct reports to provide feedback
Bachelor degree in scientific discipline or related field required.
7+ years of experience in clinical trials is required, 9+ preferred
Experience in diagnostics, biotechnology and/or pharmaceutical clinical research with responsibilities for managing all major aspects of strategic planning, organization, implementation, and delivery of clinical programs.
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