Clinical Trial Management Associate Jobs in Reston, VA

Senior Project Leader 

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

Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business.

• Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
• Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
• Reviews, provides input on, and approves project and study documents and processes, as needed.
• Represents the project or company at client meetings and scientific conferences.
• Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
• Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
• Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
• Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
• Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements.
• Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
• Uses established key performance metrics to assure successful delivery of the project that meet client requirements.
• Supervises, mentors, and supports lower level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
• Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
• Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
• Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
• Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.

Education/Requirements

Senior Project Leader:

-Bachelor's degree, preferably in a scientific discipline, with at least 11 years of experience within pharma and/or CRO;

-Master's degree with at least 9 years of experience within pharma and/or CRO;

-PhD with at least 6 years of experience within pharma and/or CRO

• Demonstrated working knowledge of the principles of clinical trial management and operations with at least 5 years of management experience in a research environment

• Prior CRO/clinical trial management of late-stage clinical trials preferred

• Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost

• Demonstrated strong problem solving and analytical skills, combined with sound business judgment

• Ability to work proactively and effectively, with creative problem-solving and collaboration skillsHighly motivated with ability to work independently and as part of a multi-disciplinary teamStrong cross-functional project management and time management skills

• Excellent verbal and written communication skills

• Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred

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

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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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