We are currently recruiting for a Project Manager for a leading Clinical Research Organization on the west coast. This position provides leadership and support to members of the multidisciplinary project team, internally and externally.
Roles and Responsibilties:
Assume primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.
Manage and execute the overall project scope, budget, and timelines. Identify project success factors for analysis, reporting, and tracking.
Manage resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, and contractual agreements.
Ensure the appropriate development of all documents by CROs including but not limited to study documents, including informed consent forms, case report forms and instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
Manage relationships with consultants to provide adequate support and services for data collection and analysis.
Ensures that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).
Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
Plans for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational devices.
Monitors adherence to project contract and budget.
Coordinate with clinical, marketing, and operations management to identify goals and scope of clinical study projects. Ensure operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed.
Enhance department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
Updates job knowledge by participating in educational opportunities, reading professional publications, maintaining personal networks, participating in professional organizations.
Attend off-site meetings and conferences, as needed.
Bachelor degree or equivalent education/degree in life science/healthcare is required accompanied by 5 years of working within clinical project management and 5 years of involvement with clinical study planning, execution, reporting and publishing activities (either at a local medical organization, investigational site, pharmaceutical company/CRO, or clinical fellowship program).
CRO experience is highly desirable.
Experience qualifying and managing external vendors.
Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies.