DOD Program Manager (Biotech)

Requirements:

•   Bachelor's Degree in Engineering, Chemistry/Science, or related field

·   Five to seven years demonstrated experience including but not limited to federal and private/industry sponsored compliance regulations governing sponsored projects budgeting, financial reporting, and policies regarding use of sponsored projects. This position will be required to use independent judgment in interpreting guidelines, adapting procedures, or in recommending approaches or solutions.

·   Five to seven years' experience in building partnerships to improve processes and facilitate clinical and research administration innovation.

·   Five to seven years of a record of success in roles involving work with faculty and a deep appreciation for the culture of a research institute, or academic institutions

·   Five to seven years knowledge and experience working with agency/sponsor guidelines relative to clinical and research administration.

Essential Job Functions:

         Project Management:

• Independently manage day-to-day operations of the project, ensuring the quality performance of award maintenance, including account creation, budget and expense analysis, and expenditure review.
• Gather and interpret medical, surgical, and laboratory data regarding clinical trial subjects, ensuring the integrity of the study protocol.
• Develop and track project plans, timelines, and budgets to ensure all deliverables meet quality and compliance standards.
• Prepare and submit all necessary documents for Institutional Review Board (IRB) review.
• Assist with the collection and shipping of specimens per protocol and interact as needed with offices and departments within the health system to facilitate project needs.

• Oversee sub-contract expenses in addition to managing incoming and outgoing invoices accurately and in a timely manner.

   

• Data Management and Entry:

• Collect and enter data into study databases, completing study forms for submission to sponsors and/or appropriate agencies.
• Record protocol-specific treatments, abstract data, complete case report forms, and respond to inquiries as needed.
• Obtain data, including images, specimens, and medical records from outside facilities, ensuring compliance with all protocol requirements.

       Patient Interaction and Enrollment:

• Engage with study patients to collect data, explain the trial to patients and their families, and complete patient enrollment and consent processes.

• Participate in clinic activities to facilitate enrollment, consent patients, and complete any follow-up or research activities required.

  Cross-Functional Collaboration and Communication:

• Serve as a backup for the Program Director, providing support on high-level project initiatives and contributing to the overall strategic direction of the program.
• Maintain effective and clear communication with project stakeholders, including sponsors, investigators, regulatory authorities, and internal staff, to provide regular updates on project status and address any issues.

• Adhere to best practices in clinical and research administration and ensure transparency and collaboration among all team members and stakeholders throughout the project lifecycle

   Knowledge/Skills/Abilities:

• General knowledge of accounting principles and general financial management practices.
• General understanding and knowledge of biomedical research, medical terminology and general life sciences disciplines
• Ability to comprehend, interpret and analyze information; define problems and identify patterns, tendencies and relationships; formulate logical and objective conclusions; and recognize alternatives and their implications.
• Ability to prioritize fluctuating workloads and maintain high productivity levels in the face of changing priorities and frequent interruptions.
• Proven ability to maintain confidentiality
• Expert knowledge of electronic research administration systems.
• Working knowledge of computer applications and data management.
• Ability to work as a member of a team
• Ability to work well under pressure and meet multiple and sometimes conflicting deadlines
• Ability to interact in an appropriate and professional manner
• Demonstrated cooperative behavior and positive-problem solving and conflict resolution skills
• Proven ability to engage positively, solve problems constructively, and handle conflicts with a diplomatic approach.

• Available to work dependable, flexible shift

   

 Purpose of Position: 

The Program Manager will play a pivotal role within the Project Study Team for a Department of Defense (DOD) grant award, reporting directly to the Principal Investigator. This position demands not only a comprehensive understanding of clinical research processes and regulatory requirements but also a strong foundation in project management principles.

 

In this capacity, the Program Manager will be instrumental in fostering collaboration among diverse teams, including clinical operations, data management, regulatory affairs, and biostatistics. By effectively coordinating activities across these groups, the Program Manager will ensure that all project goals are met efficiently and within designated timelines.

 

Key responsibilities will include developing and implementing detailed project plans, tracking progress, and adapting strategies as needed to maintain compliance with all applicable regulations and guidelines. The Program Manager will be adept at identifying potential challenges before they arise and will utilize strategic problem-solving skills to address issues proactively.

 

In addition to overseeing the day-to-day operations of the project, the Program Manager will also serve as a liaison between various stakeholders, facilitating clear communication to keep everyone informed of developments and changes. This role is crucial for maintaining the integrity of the research, ensuring that high standards of quality and regulatory compliance are upheld throughout the project lifecycle. 

The Program Manager will demonstrate strong leadership capabilities, exceptional organizational skills, and a commitment to quality outcomes, all of which are necessary for driving the successful execution of this important DOD grant initiative.

Salary: $85,000-$130,000/yr.

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