CRO - Senior Project Manager

Job Title: Senior Project Manager

The Senior Project Manager is an advanced leader in clinical program management in the clinical research industry, and manages, executes and reports on clinical study operations. This position provides leadership by building and motivating team members. The Senior Project Manager will support members of the multidisciplinary project team, internally and externally. When challenges or issues arise, you will use superior problem-solving skills to navigate a solution, communicating with all stakeholders transparently, providing a successful resolution. Responsibilities encompass the overall management of a project including budgeting, timeline adherence, internal and external communications, and project deliverables. Acts 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 include the following. Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed

• Leads the execution of clinical research projects or programs and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.
• Lead project through its full cycle by assessing requirements including scope, budget, and resource stipulations
• Act as primary liaison between the Company and the sponsor to ensure project launch, conduct, and closeout according to the sponsor and the Company's contractual agreement.
• Communicate efficiently among multiple stakeholders: sponsors, cross-functional teams, project vendors, and site staff.
• Effectively communicate project progress to stakeholders, generates periodic updates and prepares formal presentations for required forums
• Coordinates with clinical, marketing, 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.
• Ensures the appropriate development of all documents including but not limited to: study plans, informed consent forms, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
• Anticipates and identifies project risks, timeline changes and analyzes the scope, cost and resource impact and communicates accordingly
• Develops, manages and tracks project budget(s) within an established financial framework.
• Implements tools, techniques and processes to enable informed decision making by the project teams, management, and project sponsor as appropriate
• Participates in the review of clinical data for analysis.
• Trains, mentors, and coaches junior staff by providing timely and accurate feedback regarding performance on project activities and deliverables.
• Ensures all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).
• Drives a culture of project management excellence in the organization. Supports continuous improvement of project delivery practices
• Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research
• Attend off-site meetings and conferences, as needed.

SUPERVISORY RESPONSIBILITIES

• Position supervises the activities of assigned team members regarding project deliverables and may have administrative supervision of staff. Position requires extensive experience and judgment to accomplish study defined goals.
• Serves in a supervisory capacity. Ability to train and provide higher level guidance in the development of project management tools. Mentors staff in project management process, SOPs, tools and technical guidelines.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION and/or EXPERIENCE

Bachelor degree or equivalent education/degree in life science/healthcare is required accompanied by 8 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/or 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.