CRO-Project Manager

Job Title: Project Manager

Location: Remote

Job Description:

The Project Manager is a proven leader in clinical program management in the clinical research industry, and manages, executes, and reports on clinical study operations. This position provides leadership and support to members of the multidisciplinary project team, internally and externally. Responsibilities encompass the overall management of a project including budgeting, timeline adherence, internal and external communications, and project deliverables. Under limited to no supervision, act as the liaison between the sponsor, team members, and sites while managing projects to ensure quality service. This position will be part of the Clinical Operations Team, which is responsible for planning, executing, managing, and closing projects associated with the company clinical study plans.

Essential Duties and Responsibilities:

• Assume primary accountability for assigned clinical research projects and ensure 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.
• Lead the development of study specific protocols, consent forms, and other trial related materials as required.
• Ensure the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
• Participate in the review of clinical data for analysis.
• Ensure 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.
• Plan 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 device. Monitor 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 participate in FDA or other regulatory authority inspections, as needed.
• Support the management and oversight of clinical study related vendors. Review site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements.
• Provide therapeutic training and guidance to clinical team.
• Enhance department and organization reputation by participating in departmental or corporate initiatives.
• Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Attending off-site meetings and conferences, as needed.
• Perform other miscellaneous related duties, as required.

Education and/or Experience:

• Bachelor’s degree or equivalent education/degree in life science/healthcare is required accompanied by 5 years of working within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.
• CRO experience is highly desirable.
• Experience qualifying & managing external vendors.
• Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies.
• Experience writing, reviewing, and editing protocols and clinical study reports as well as working knowledge of the FDA submission process.

Skills and Abilities:

• Ability to facilitate a teamwork philosophy with a positive attitude.
• Extensive organizing and coordinating skills, teaching and facilitation skills, ability to assess training needs and objectives.
• Extensive experience overseeing and coordinating the work of others.
• Ability to work effectively and efficiently handling multiple tasks simultaneously.
• Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
• Ability to manage multiple deadlines.
• Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.
• Strong computer skills, including Microsoft Office.