System One Services Clinical Trial Manager in Warsaw, Indiana
Clinical Trial ManagerWarsaw, Indiana
Category:Scientific & Clinical
Compensation Range:105000.00 - 105000.00
Our client is currently seeking a Clinical Trial Lead for a long-term engagement with one of their Global Pharmaceutical clients in Warsaw IN or Raynham MA . This role will be remote working at home until Covid restrictions are lifted.
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
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.
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.
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 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
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.
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.