Program Manager - Charlestown, United States - Spaulding Hospital-Boston & Cambridge(SRN,SRH,SHC)

Description

Position Overview:

The mission of the Spaulding Neurorehabilitation Laboratory (SNL), directed by Dr. Joseph T. Giacino, Professor of Physical Medicine and Rehabilitation at Harvard Medical School, is to develop more precise diagnostic and prognostic assessment methods, and more effective treatment interventions, to maximize recovery and improve quality of life for persons with acquired brain injury. Areas of focus include the development of high-precision instruments and approaches to outcome assessment, neuromodulatory treatment interventions and knowledge translation.

Examples of SNL projects include:

• The Spaulding-Harvard Traumatic Brain Injury Model System; one of 16 centers in the U.S., making up the largest and longest running longitudinal study of TBI in the world.
• Outcomes Core Lead for the nation's largest prospective TBI study, "Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI).
• More information about the SNL can be reviewed at

We are recruiting an experienced and highly motivated individual with strong research management skills to serve as Program Manager for the lab. This person is primarily responsible for operational management of a large and diverse portfolio of research activities, including federal, industry and foundation-funded multicenter clinical trials and observational studies. They will communicate with various internal and external stakeholders and will oversee the finances and regulatory compliance of the lab. The Program Manager works with and under the direction of the Laboratory Director.

Key Responsibilities:

General Administrative

• Ensures fluent day-to-day implementation of all laboratory operations
• Demonstrates knowledge of, and compliance with all regulations pertinent to research activities
• Coordinates development and implementation of manuals of operating procedures and training certifications
• Tracks and disseminates RFA/RFP announcements
• Oversees preparation and response to audit findings and recommendations
• Coordinates and develops agendas for weekly laboratory meetings

Financial

• Develops and manages the SNL's budget, working closely with departmental administrative staff and pre- and post-award personnel in grants and contracts office, and assuring compliance with all contract/subcontract terms and conditions

Protocol Preparation, Implementation, & Review

• Initiates and participates in development of new grant proposals and helps to prepare related documentation
• Prepares budgets/justifications for all new submissions
• Prepares IRB applications and monitors continuing review timelines
• Coordinates preparation of informed consent documents, case report forms (CRFs), regulatory binders, enrollment logs, and drug/device accountability logs

Post-Award Activitie

• Develops a full understanding of all aspects of study protocols and assists PI in communicating responsibilities and requirements to study staff
• Establishes and organizes study files

Conduct of Research

• Contributes to scientific activities/research studies in accord with academic training and professional background
• Maintains effective and ongoing communication with sponsors, IRB, research participants, and PI
• Assists with development, implementation and evaluation of recruitment strategies and enrollment targets
• Assists with adverse event reporting and data quality assurance
• Assists the Principal Investigator in submission of accurate and timely closeout documents in accordance with sponsor requirements

Supervisory/Managerial Responsibilities

• Oversee and manage growth of the SNL, including hiring and management of future staff (approximately 10.0 FTE) as well as research fellows, externs and students

Qualifications

Education/Degree:

Required

• Bachelor's degree or higher from an accredited college or university (public health, neuroscience, medical sciences, psychology)
• Master's degree preferred

Experience:

Required

• Minimum of 5 years of experience in laboratory or research management
• Understanding of hospital operations
• Financial management

Preferred

• Formal training or experience in neurorehabilitation research

Skills (Specific learned activity gained through training):

Required

• Demonstrated strategic thinking, planning abilities and the ability to lead through both influence and direct authority.
• Excellent communication, presentation, and facilitation skills with the ability to communicate effectively and to lead a broad range of stakeholders.
• Strong analytical and critical thinking skills necessary to evaluate strategic initiatives and recommend changes, prior to implementing the processes.
• Interpersonal communication skills to influence, negotiate, and resolve problems effectively and to make strategic and tactical decisions with senior
  
  and clinical leaders.
• Change management skills and knowledge, including competence in changing a vision into action by executing on strategy, partnerships, goals, and
  
  measurements.
• Commitment to creating and championing Diversity, Equity, and Inclusion