Clinical Research Project Manager

Role 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. Under limited supervision, the Project Manager acts as the liaison between the sponsor, team members, and sites while managing projects to ensure quality service. Responsibilities encompass the overall management of a project including budgeting, timeline adherence, internal and external communications, and project deliverables.

• Assumes primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.
• Manages and executes the overall project scope, budget, and timelines. Identifies project success factors for analysis, reporting, and tracking.
• Manages resources and timelines associated with all study start-up and implementation activities.
• Leads the development of study specific protocols, consent forms, and other trial related materials as required.
• Ensures 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.
• Participates in the review of clinical data for analysis.
• Ensures that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).
• Serves as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
• Plans for and manages 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.
• Coordinates with clinical, business development, and operations management to identify goals and scope of clinical study projects. Ensures operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed.
• Supports the management and oversight of clinical study related vendors.
• Reviews site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements.
• Enhances department and organization reputation by participating in departmental or corporate initiatives.
• Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Attends off-site meetings and conferences, as needed.

Qualifications

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

Requirements

• Ability to facilitate a teamwork philosophy with a positive attitude.
• Organizing and coordinating skills, teaching and facilitation skills, ability to assess training needs and objectives for the team.
• 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.

Physical Demands

• Regularly reaches with hands and arms.
• Periodically required to lift and/or carry up to 10 pounds.
• Occasionally stoops, bends, kneels, and crouches; and pushes/pulls filled wheeled carts.
• Specific vision abilities required include close vision, color vision, and ability to adjust focus.

Work Environment

• Work in a home environment where the noise level is usually largely controlled by the employee.
• Travel environment where the noise level is usually moderate to high.
• Subject to many interruptions; pressure due to deadline requirements; and handling multiple tasks simultaneously while performing assigned duties.

Safety Requirements

• Employee is required to pay particular attention to safety in their home and travel environment.