Senior RWE Epidemiologist/Project Manager (US, Remote)

Senior RWE Epidemiologist/Project Manager - International Consulting Associates, Inc. (Remote)

About ICA

International Consulting Associates, Inc. is a rapidly growing company, located in the D.C./Metro area. We were founded in 2009 to assist firms with evaluating and achieving their objectives. We have become a trusted advisor helping our clients by offering cutting-edge innovation and solutions to complex projects. Our small company has grown significantly, and we're overjoyed at the opportunity to expand yet again!

We offer a range of management solutions and technical services on domestic and international programs. We are results-focused and have a proven track record supporting federal agencies and large government services primes in three main areas: Research and Data Analysis, Advanced-Data Science, and Strategic Services. And if that isn't amazing enough, ICA has established itself as a critical partner of the US Food and Drug Administration (FDA). We currently support multiple analytics and research programs with offices including the Center for Devices and Radiological Health (CDRH) and the Center for Medicaid/Medicare Services (CMS).

We believe in our people! We support our high-performing team and encourage work/life balance. We strive to create and foster an environment of collaboration - one team. We care about our mission and delivering value that makes a real-world impact. We are committed to hiring and developing diverse, dynamic, and highly skilled teams in an atmosphere that is safe and inclusive. We are passionate about creating solutions that leverage technology, data science, and machine learning to simply help make our world a better place!

We are looking for an experienced Senior RWE Epidemiologist/Project Manager to join our team!

Role

ICA’s Public Health/RWE Safety Studies team supports clients (e.g., federal organizations) in their mission to protect and promote public health by conducting safety studies in a variety of clinical areas. These safety studies assess real world risks and adverse events associated with medical devices through assessment of electronic healthcare data including administrative claims data and electronic medical record (EMR) data. Joining the team is an opportunity to help inform decisions related to pharmacological and medical devices and thus improve the lives and well-being of millions of people.

The Senior RWE Epidemiologist / Project Manager is responsible for overseeing and managing all real-world evidence (RWE) studies performed by the ICA RWE Team. This includes developing and maintaining comprehensive project work plans, ensuring effective communication between stakeholders, and facilitating meetings and presentations. The Senior RWE Epi/PM will leverage their extensive expertise to provide high-level review of study deliverables, ensuring content and quality align with both ICA and client standards. They will work closely with the Program Manager, who handles higher-level strategic activities and provides guidance on overall program direction.

The Senior RWE Epi/PM plays a crucial role in driving client success by proactively identifying and addressing potential challenges, ensuring timely delivery of high-quality deliverables, and maintaining a strong focus on client satisfaction. They will build and maintain positive relationships with clients, serving as a trusted advisor and go-to resource for RWE expertise. By deeply understanding client needs, preferences, and strategic objectives, the Senior RWE Epi/PM will tailor project approaches and deliverables to maximize value and impact for each client.

Job Qualifications And Requirements

• Bachelor’s Degree (preferably in Biomedical Engineering or Public Health); Masters Degree preferred
• 10 years of experience in clinical research project management within healthcare industry i.e., medical device company (preferred), pharma, CRO, and/or healthcare facility
• At least 7+ years project management experience is required
• Must have analytical skills, be detail oriented and have good interpersonal skills.
• Knowledge and/or certification on implementation of clinical research related Good Clinical Practice (GCP) and Medical Device Good Distribution Practice (GDP) desired
• Knowledge of FDA/ISO regulatory requirements is preferred
• Experience managing total lifecycle of clinical research projects, i.e., initiation, development, conduct, closure with proven ability to plan and prioritize workload and meet deadlines
• Skilled at evaluating program performance, summarizing findings, analyzing results to identify strengths and weaknesses and alternative solutions to problems, and forming an action plan
• Excellent communication, presentation, and interpersonal skills, both written and oral; experience and ability to communicate with decision-makers and stakeholders at all levels within the government and industry; ability to conduct effective, professional, high-quality presentations
• Ability to effectively manage competing priorities
• Ability to work both independently and in a collaborative team environment
• Excellent problem-solving, analytical, and organizational skills
• Must be able to obtain a Public Trust Government Clearance
  
  

Position Reports To

• ICA Medical Officer/RWE Program Manager
  
  

Preferred Additional Qualifications

• Previous experience working and/or collaborating with researchers from federal government agencies whose mission relates to public health (e.g., NIH, CDC, FDA, HRSA, or other HHS agencies).
  
  

What We Offer

• Health Insurance
• Dental Insurance
• Vision insurance
• Health Spending Account
• Flexible Spending Account
• Life and Disability insurance
• 401(k) plan with company match
• Paid Time Off (Vacation, Sick Leave and Holidays)
• Education and Professional Development Assistance
• Remote work from anywhere within the continental United States
  
  

Location: This position is remote, but our clients are primarily based in the DC-metro area. While we encourage flexible work hours based on location, it is essential that the successful candidate be responsive to client scheduling. Occasional travel (< 5% time) to the DC-metro area will be required at minimum twice a year.

Clearance

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information; Public Trust clearance is required.

Additional Information

ICA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity or expression, national origin, genetics, disability status, protected veteran status, age, or any other characteristic protected by state, federal or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.