Clinical project manager job description

The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, helping to deliver projects to the benefit of the patients we serve.

Parexel currently has Home Based Project Leadership opportunities at levels to fit your experience and career goals.
.
You will oversee all elements of the trial to ensure project deliverables and client satisfaction are executed to the highest standards. You will actively lead cross functional Parexel and client teams by combining deep clinical research experience with insight into client pressures to develop the right solutions for the clients. Your experience running global clinical trials across all phases will help you achieve operational excellence through on time and on budget delivery to the highest quality. As member of the Project Leadership team, your goal is to exceed client expectations, and help your team achieve success by serving as a role model and coach.

The Global Project Leadership department has dedicated members at all levels who are aligned to work with specific types of clients and deliver solutions customized to fit those client’s needs, working on projects spanning across all phases of global clinical trials, in a wide array of therapeutic areas.
Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with a minimum, 2+ years' experience leading Global Clinical Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director and Project Director.

To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member’s growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills.

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination

#LI-REMOTE

Job DescriptionProvides project management to support functions of Infection Control and Clinical Compliance teams to ensure effective departmental operation and optimal communication of departmental priorities regarding infection control and clinical compliance throughout the hospital.
PRINCIPAL DUTIES AND RESPONSIBILITIES:

Assists hospital staff in developing analytic and measurement strategies for Infection Control quality improvement projects. Supports projects associated with emerging infectious diseases and pandemic related activities. Participates in data collection and data entry activities as directed to support Centers for Disease Control's National Healthcare Safety Network (NHSN), The Joint Commission (TJC), Center for Medicare & Medicaid Services (CMS) Quality Measures, Massachusetts Department of Public Health (DPH), and Boston Public Health Commission quality measurement and reporting requirements. Conducts data analysis, population review and medical record chart reviews to investigate quality trends and identify gaps or areas for improvement; works with the Infection Control team, the Clinical Compliance team, physician leaders and nurse directors to summarize findings, develop recommendations for improvement, and track the impact of implemented changes. Collaborates to develop agenda and content for the Infection Prevention and Control Committee and the Antibiotic Stewardship Committee. Supports Infection Control Policy development and/or review. Works with hospital department directors, quality leaders/representatives and chiefs to develop annual quality measurement and improvement plans connected to Infection Control and Compliance measures, including identification of measures to be tracked locally versus centrally. Acts as a resource to departmental quality leaders and service chiefs. Establishes effective and collaborative working relationships with members of the hospital community, clinical departments, administrative departments, hospital committees, and quality and safety staff across the Mass General Brigham System, as needed. Keeps current with data abstraction specifications in Infection Control and in TJC Standards to address emerging trends and reporting initiatives. Integrates key concepts into work across hospital. Works with the team to assure hospital compliance with federal and state regulatory, and accreditation requirements. The project manager communicates requirements of the compliance process to hospital committees and staff. Facilitates readiness and preparation for DPH, TJC and CMS site visits ensuring proactive compliance with regulations and standards. Assists with on-site surveys. Facilitates completion of regulatory tasks following any site survey.

Brigham and Women's Faulkner Hospital, an affiliate of Mass General Brigham, is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve. At Mass General Brigham, we believe in equal access to quality care, employment and advancement opportunities encompassing the full spectrum of human diversity: race, gender identity, sexual orientation, ability, religion, ethnicity, national origin and all the other forms of human presence and expression that make us better able to provide innovative and cutting-edge healthcare and research.

Brigham and Women's Faulkner Hospital is a 171- bed non-profit, community teaching hospital located in Jamaica Plain directly across the street from the Arnold Arboretum. Founded in 1900, Brigham and Women's Faulkner Hospital offers comprehensive care in a wide variety of specialties. Brigham and Women's Faulkner Hospital is a designated Magnet hospital by the American Nurses Credentialing Center, a recognition that fewer than nine percent of all US hospitals receive.

At Brigham and Women's Faulkner Hospital, we believe that everyone should have the chance to live a healthy life. From creating breakthroughs that have paved the way for treatments around the globe to training the next generation of providers, our patients, and those we may never meet, are at the center of everything we do. If you're looking for more than a career, join Brigham and Women's Faulkner Hospital. Our patients call it better care. Our employees call it home.

Qualifications
Bachelor's Degree required. Experience in healthcare infection control, clinical compliance, quality, risk or patient safety preferred Staff adheres to all I C.A.R.E. Standards Microsoft Office required. Additional data computing and strong electronic data base skills preferred. Strong organizational and interpersonal communication skills required Strong data analysis and data display skills required Must demonstrate maturity and discretion to handle confidential matters of a very sensitive nature

EEO Statement
Brigham and Women's Faulkner Hospitalis an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Partner's Healthcare is acting as an Employment Agency in relation to this vacancy.

Our client is a fast-growing, global medical device company focusing on non-invasive treatments for some of the most challenging diseases. For their main office in Dallas, TX, they are looking for a Clinical Project Manager to support global clinical trials.

This is a full time, permanent, W2 position. Relocation allowance is available, but no visa sponsorship.
Requirements
Bachelors degree in the science field. Advanced degree preferred.
Minimum 3 years of experience as a Clinical Project Manager with PMA Class III device process.
Minimum 5 years of US and global regulatory/clinical trial experience in the medical device industry including experience executing feasibility, pivotal, and post-market approved trials.
Experience with global regulatory processes /various international clinical trials.
Experience writing clinical trial documents including protocols, amendments, and clinical study reports
Demonstrates strong database management skills, including descriptive data analysis
Knowledge of financial principles in budgeting and tracking of clinical trials and effective management of assigned internal and external resources
In-depth knowledge of global clinical trial processes and regulations
Demonstrates current working knowledge of all phases of clinical trial development from concept through final CSR and knowledge of operational and regulatory processes involved with clinical trials.
Able and willing to travel as needed, including international travel (20%)

Responsibilities:

Manage successful execution of assigned global clinical studies in adherence to Good Clinical Practices (ICHGCPs) and in compliance with appropriate company Standard Operating Procedures (SOPs) as applicable under the Regulatory Agency(ies) governing the study, and any other applicable guidelines and regulations.
Responsible for clinical operational oversight and execution of assigned trial(s) in order to achieve expectations of quality, timelines and budget, and study conduct.
Manage successful Clinical Research and Clinical Trials submissions (as needed) to governing Regulatory Agency(ies) in full compliance with local regulatory laws
Builds and sustains extensive global networks across multiple functions at study team level.
Develop and share best practices to accelerate project timelines
Manage relationships with internal CRO and external site personnel, vendors, key opinion leaders, sub-contractors and applicable regulatory agencies.