Dexis Consulting Group

Senior Program Manager- Medical Device Literature Reviews

Posted Date 2 months ago(4/20/2020 10:23 PM)
Job ID
2020-2198
# of Openings
1
Job Locations
US-DC-District of Columbia
Job Area
Dexis Professional Services
Clearance Level
Not applicable
Type
Full-Time

About Us

Dexis Professional Services (DPS) is a wholly-owned, independently operated business unit established in 2016 to provide support services to United States Government (USG) agencies that were previously provided by the parent company, Dexis Consulting Group (Dexis). Committed to excellence in institutional support and staff augmentation, DPS draws on the parent company’s 15+ years of experience fielding domestic and overseas technical, operational, professional and managerial staff for various USG clients.

Do you want to be part of an organization that offers meaningful assignments and opportunities to enhance your skills and expertise? At DPS, you will experience a corporate culture of collaboration, equality, and trust. You will be given the means and mentorship needed to succeed, and your creativity will be rewarded. Join a growing, dynamic company as we continue to expand our portfolio.

About the Position

The mission of the US Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH ensures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. As part of CDRH’s regulatory mission, systematic literature reviews (SLRs) are routinely conducted in order to canvas published literature and identify medical device safety signals, or other device performance, quality, and effectiveness issues.

 

The objective of this contract is to complete SLRs on up to 20 high priority device-safety areas. The Senior Program Manager and team of consultants shall develop the protocol for completing each SLR, including identifying the key words and inclusion/criteria for the review and analysis. After approval of the strategy from the CDRH Office of Clinical Evidence and Analysis (OCEA), the Contractor shall execute the SLR and provide the final report to CDRH within 10 business days.

Responsibilities

The Senior Program Manager will be responsible for overseeing and collaborating with a roster of technical consultants in order to execute the required SLRs. The Senior PM will draw upon epidemiological knowledge to work with other scientists and program consultants in various aspects of the protocol design process, review of existing literature and data, and preparation of summaries.

The Senior PM will also be responsible for interfacing with CDRH and Office of Clinical Evidence and Analysis (OCEA) staff and ensuring the quality and timely completion of deliverables, which include SLR summary reports, monthly reports, meeting minutes, and a summary spreadsheet of all completed SLRs. 

 

The following is a general outline of expected tasks. Note that the Senior PM will be largely focused on Tasks 1,2, and 4, but will be involved in each stage. 

 

Task 1: Develop a Defined Protocol for Each Systematic Literature Review

Task 2: Propose a Protocol for Each Systematic Literature Reviews

Task 3: Conduct Systematic Literature Reviews and Provide Summary Reports

Task 4: Provide a Summary Document to CDRH that Captures Output of Each SLR

 

The Senior PM may have opportunities to work on other corporate initiatives as part of this contract. 

Qualifications

Minimum Requirements:

  • Master's degree or higher in epidemiology, biomedical engineering, or other health science-related field; PhD preferred
  • 8-10 years or more of relevant experience in epidemiological or medical device research and data analysis in the health sector
  • Demonstrated experience performing systematic literature reviews and writing research papers
  • Excellent communication, technical writing, editing, and time management skills
  • Demonstrated qualitative and analytical skills
  • 1-2 years of supervisory and program/project management experience; prior client management experience strongly preferred 

 

At Dexis Professional Services (DPS) we align ourselves with the core values of our parent company, Dexis Consulting Group (Dexis). Ingenuity, Integrity, Investment in People-these are the guiding principles of our culture. We empower our staff to work together with colleagues at all levels and be part of the decision-making process; we create transparency in our operations with our clients and employees; and we offer our people opportunities to grow and challenge themselves in meaningful ways. We’re committed to excellence in institutional support and staff augmentation in the global development arena. As a DPS employee, we will challenge you, we will empower you, and we will mentor you.

If you are passionate about this opportunity, submit your application by clicking the apply for this job online button.

Only those applicants who meet the above criteria will be contacted for interview. DPS is an equal opportunity employer offering employment without regard to race, color, religion, sex, sexual orientation, age, national origin, citizenship, physical or mental handicap, or status as a disabled or Vietnam Era veteran of the US Armed Forces.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Need help finding the right job?

We can recommend jobs specifically for you! Click here to get started.