Remote Clinical Data Abstractor Jobs in Alexandria, VA

Project Leader - Oncology & Infectious Diseases 

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 strive to build a collaborative culture at the intersection of being a performance and people driven company. We're 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

The Project Leader (PL) is critical to the successful conduct of government-sponsored clinical research projects, serving as the matrix leader of the core project team. The Project Leader is accountable for successful delivery of clients' statement of work activities within timeline and budget. Leveraging experience in clinical trial operations, the PL leads and manages cross-functional teams, fostering collaboration across clinical, regulatory, data management, and operational functions to achieve project goals. The PL develops and maintains a positive relationship with clients and other external stakeholders, oversees deliverable quality, mentors staff, and ensures efficient project execution utilizing electronic database systems and clinical trial management platforms. The PL is responsible for the continuous monitoring, identification, escalation and mitigation of project risk to support successful study outcomes and regulatory compliance. 

• Accountable for technical, scientific, and fiscal execution of government research projects through collaboration with staff from other departments, including but not limited to Clinical Operations,Biostatistics, Clinical Data Management, Clinical Data Systems, Program Management, IT, Web Development, Finance, Contracts, Regulatory and Pharmacovigilance.
• Sets priorities for the project team, ensures quality processes are followed, and collaboratively establishes and maintains deliverable timelines.
• May provide performance related feedback to department managers for project staff.
• Serves as the client's, investigators' and other stakeholders' primary point of contact for the project and/or assigned protocols.
• Proactively addresses client's needs for ongoing studies/activities and engages with clients regarding new opportunities.
• Develops, reviews, and approves project plans, study documents, and processes/SOPs, as needed.
• Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and execute project decisions considering client needs, budget, scope, and the current state of theresearch field.
• With input from team members, defines solutions that meet client's needs within project-defined scope.
• Defines and approves approach or solutions to project requirements, risks and issues. Communicates risks and contingencies to clients and internal Government Delivery oversight.
• Develops, maintains, and acquires approval of budgets and statement of work documents and subsequent modifications prior to distribution to clients , as well as invoices and subagreements.
• Liaises with corporate leaders and other Emmes departments to ensure staff resources are continuously informed, trained and efficiently utilized within the project team to successfully execute the project scope.
• Represents the project in Corporate meetings (e.g., project reviews), provides central status reporting and information solicitations with Executive leaders, as applicable.
• Uses key performance metrics to successfully execute the project scope.
• Mentors project staff and supports staff development, may be responsible for the development of new Project Leaders.
• Models Emmes culture of integrity, accountability, collaboration, innovation, and perseverance across internal and external teams .
• Aids in continuous corporate knowledge expansion by participating in relevant (internal and external) meetings/trainings to provide information learned and best practices to project teams,functional/service groups, and corporate entities as applicable.
• Promotes and implements relevant corporate initiatives as directed.
• Leads or contributes to the development of operational strategy, budget, and proposal content for new business opportunities, as assigned.
• Represents Emmes at proposal, business development meetings, conferences, or other meetings, asrequested.

Education/Requirements

Project Leader:

Bachelor's + 8 years of empirical knowledge of the key accountabilities/duties/responsibilities for the position with a typical tenure of at least 3 years project management experience in a research environment.

Master's + 6 years of empirical knowledge of the key accountabiliies/duties/responsibilities for the position with a typical tenure of at least 3 years project management experience in a research environment.

PhD + 3 years of empirical knowledge of the key accountabiliies/duties/responsibilities for the position with a typical tenure of at least 3 years project management experience in a research environment.

• Project Delivery Track Record: Demonstratable track record of successfully delivering complex/high-priority clinical trials or clinical research projects within the agreed time, quality, and budget. Experience in federally-funded research is preferred.

• Clinical Research Knowledge: Demonstrated working knowledge of the principles of clinical research management and operations.

• Problem-Solving: Demonstrated strong problem-solving and analytical skills, combined with sound business and ethical judgment.

• Communication: Excellent verbal and written communication skills for client, team, and scientific interactions.

• Leadership & Teamwork: Ability to work proactively and effectively, with creative problem-solving and collaboration skills. Highly motivated with the ability to work independently and as part of a multi-disciplinary team. Ability to supervise, mentor, and support lower-level project leaders and staff.

• Project Management: Strong cross-functional project management and time management skills.

• Therapeutic Expertise (Preferred): Broad understanding of a therapeutic area, clinical trial design, and/or process expertise to influence and execute project decisions.

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:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

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The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

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