Protocol Data Abstraction (PDA) Team Lead

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients lives and act accordingly. We stive to build a collaborative culture at the intersection of being a performance and people driven company. Were looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

This position supports "Essex, a Veridix AI company". Essex is a biomedical informatics and health information technology-focused consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing complex health and biomedical information programs as a prime contractor for clients in the Federal Government, research academia, and private sectors.

The Protocol Data Abstractor (PDA) Team Lead is responsible for managing the team of protocol data abstractors responsible for abstracting protocol content (e.g., lead organization, participating sites, study status information, IRB, funding) with new trials and amendments, performing data updates, addressing user inquiry requests, associated with clinical trials reporting. They ensure timely and accurate data entry information, adhering to established program quality standards.

• Directly managing and supervising the team of protocol data abstractors and related performance management discussions, e.g., includes expectations-setting and monitoring alignment to metrics.

• Ensuring staff are trained on daily tasks, performing on schedule with complete accuracy.

• Ensuring consistent abstraction, curation, and coding of clinical trial related data.

• Suggesting system and process improvements supporting continuous improvement.

• Suggesting system and process improvements; working closely with the development team on system improvements and enhancements; user acceptance testing (UAT).

• Working closely with the Associate Director to provide consistent data quality and immediately address issues that arise from the customer and user community.

• Training new employees; leveraging senior PDA staff/subject matter experts.

• Performing quality control reviews on the teams trial abstractions, support tickets, trial updates, user communications.

• Updating and maintaining Standard Operating Procedures (SOPs) for the team.

• Passionate; enjoys working in a fast-paced, collaborative environment.

• Ability to attend meetings as a program liaison.

• Ability to troubleshoot and appropriately report unexpected problems that may arise during the data abstraction of clinical trials.

• Ability to effectively incorporate diverse feedback from the user community into a high-quality document.

• Ability to communicate effectively with high-level personnel and stakeholders.

• Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize.

• Highly detail-oriented with special attention to quality and quality control.

• Exceptional written and oral communication skills with demonstrated expertise with grammar, syntax, and format.

• Ability to work and learn in a busy setting, both independently and within a team.

• Willingness to perform tasks that may fall outside of the normal daily responsibilities.

• Proficient with computer usage and Microsoft Office applications, e.g., Word, Excel, Teams.

• Knowledge of Quality Assurance/Quality Control processes (Desired)

• Familiarity with clinical trials research (Desired)

• Familiarity with clinical trials, both interventional and non-interventional (Desired)

• Bachelors Degree

• In addition to educational requirements, a minimum of four (4) years of progressively responsible job-related experience including one (1) year of experience in a leadership capacity. (May be pharmaceutical, clinical, etc.) experience in a pharmaceutical, biotechnology and/or clinical environment.

• Work for this position must be performed in the United States (required). Candidates local to Rockville, MD are preferred.

• Applicants selected for this position will be subject to a government security investigation and must meet eligibility requirements for Public Trust positions. Visa sponsorship is not available.

• Successful applicants will be required to travel to an NIH-designated facility for security badging within 60 days of hire. Expenses will be reimbursed.

Emmes requires all US based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.