Clinical Research Program Manager

The Clinical Research Program Manager is responsible for the administration and coordination of the PRECiSE study, a multicenter PCORI funded trial of pregnancy outcomes in Day 3 versus Day 5 embryo transfer in women undergoing in vitro fertilization. This role will oversee the operations of the Clinical Coordinating Center. Responsibilities include development and maintenance of the trial protocol and study operations materials; overseeing study administration at the enrolling sites including maintenance of and compliance with the study protocol; study site and project committee communication, regulatory documentation for the study, and overall study management. This role will have extensive interaction with project stakeholders – investigators, study site members, sponsor, subcommittee members and other collaborators including travel to study sites. Previous experience in clinical research and interest in Ob-Gyn research highly preferred.

Essential Responsibilities (but not limited to):

• Serves as the administrative resource and liaison for the program, interacting with all levels of personnel, both internal and external.
• Is knowledgeable in all aspects of assigned research trials to be able to evaluate questions and problems.
• Ensures that all program policies and procedures are developed and up to date.
• Maintains daily correspondence (via email and phone) with all team members and external study/project sponsors in a professional and timely manner, archiving records of correspondence per NIH, FDA, and/or other applicable Federal, State, and local regulations.
• Develops program-specific performance measures to assess effectiveness and success of program components. Implements data collection processes and communicates performance through periodic reports to working and executive groups.
• Has the authority to direct and support employees daily work activities. Has the direct responsibility to undertake the following employment actions: hiring, termination, corrective action and performance reviews. Direct Reports: 4-6 Indirect Reports: None
• Assists in planning, monitoring and/or managing budget in functional area of department.

Required Qualifications:

• Bachelor's degree required; Master's degree preferred.
• 3-5 years related work experience required, 0-1 years supervisory/management experience required.
• Experience in program and/or project development and implementation.
• Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. May produce complex documents, perform analysis and maintain databases.

Competencies:

• Written Communications: Ability to communicate complex information in English effectively in writing to all levels of staff, management and external customers across functional areas.
• Oral Communications: Ability to verbally communicate complex concepts in English and address sensitive situations, resolve conflicts, negotiate, motivate and persuade others.
• Knowledge: Ability to demonstrate broad and comprehensive knowledge of theories, concepts, practices and policies with the ability to use them in complex and/or unprecedented situations across multiple functional areas.
• Team Work: Ability to act as a team leader for small projects or work groups, creating a collaborative and respectful team environment and improving workflows. Results may impact the operations of one or more departments.
• Customer Service: Ability to lead operational initiatives to meet or exceed customer service standards and expectations in assigned unit(s) and/or across multiple areas in a timely and respectful manner.

Physical Nature of the Job: Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally.

As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment. Learn more about this requirement.

More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.

Equal Opportunity Employer/Veterans/Disabled