Senior Clinical Project Manager
GENERAL POSITION SUMMARY (PURPOSE, FUNCTION, RESPONSIBILITIES)
The Clinical Project Manager is responsible for independently managing multiple clinical trials of moderate complexity or managing a broader range of activities on large multi-center studies. The Clinical Project Manager is expected to address site and vendor related issues, with assistance as needed. Specific responsibilities include the clinical trial management of timelines, budgets, resources, investigational sites, CROs, ancillary vendors along with key project deliverables in compliance with SOPs, Federal and international regulations and Good Clinical Practice (GCP) guidelines. The Clinical Project Manager works under the direction of the Senior Director, Clinical Development.
SPECIFIC POSITION DUTIES (TASKS, SKILLS)
Develop outsourcing specifications for vendor requests for proposals and participate in and guide study team in vendor selection and management
Contribute to the writing and or review of clinical documents such as Protocols, informed consents, Investigator Brochures and operational plans
Execute trial operational plans while ensuring compliance to SOPs, Federal and international regulations and GCP
Manage and collaborate with all team members regarding operational activities pertaining to the execution of one or more clinical trial(s)
Manage all aspects of clinical trial operations, including vendor performance, internal metrics, quality assurance checks and communication of trial status within and outside the trial team.
Participate in the conduct of monitoring visits as appropriate including pre-study, initiation and co-monitoring visits.
Manage study timelines according to changing requirements. Build stakeholder commitment to deliverables and ensures progress toward the completion of trial(s) in line with agreed study objectives
Prepare and update key project documentation (progress reports, timelines, and meeting minutes) ensure adverse events are reported according to regulatory requirements and provide updates to management
Manage vendor to Scope of Work (SOW), quality, and budget. Review and approve all vendor invoices and manage accruals and SOW changes
Work with CRO and or core team members to address issues and risks associated with achieving the deliverables and develop risk mitigation plans
Review, complete and assure implementation of corrective action plans in conjunction with senior management at individual sites and across the study as applicable. May participate in internal/external study related audits.
Develop relationships with key opinion leaders and investigative sites
Regularly meet with the Senior Director, Clinical Development to discuss overall clinical trial(s) plans, updates forecasting and potential issues or recommendations
Perform other activities as assigned
Competency Expectations:
A drive to achieve the highest quality of work at all circumstances
Thorough understanding of GCP guidelines and Federal and international regulations as well as a good understanding of cross-functional clinical processes including clinical monitoring, data management, biostatistics, medical writing, drug safety and regulatory affairs
Ability to understand strategic goals and meet the business needs of the company
Ability to develop good interpersonal relationships with medical professionals
Ability to manage multiple, complex, and global projects
Ability to independently manage and provide tactical and leadership guidance to the clinical trial project team
Strong verbal and written communication and presentation skills
Strong interpersonal and negotiation skills
Ability to utilize a variety of software programs such as Microsoft Office products (e.g., Project, Excel, Word, PowerPoint, Access) and clinical database software
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed, as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
Estimated Salary: $20 to $28 per hour based on qualifications.
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