Coordinator and Data Repository Manager

Coordinator and Data Repository Manager

US Remote

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee - from entry level through top executive - to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

Emmes is seeking a Scientific Project Coordinator and Data Repository Manager to assist with a range of activities in support of a large data repository for cancer clinical trials, and to assist with various tasks related to cancer clinical trials and scientific studies related to those trials, including working with oncologists and laboratory scientists to develop and implement clinical research, specimen-based, and pre-clinical research studies.

• Coordinating data submissions into the repository from multiple study teams in a timely manner. Tasks include performing data intake procedures, performing quality-control reviews of the data, communicating data review outcomes to study teams, managing and reviewing data resubmissions, ensuring legal and regulatory review, tracking submissions, and performing related follow-ups.
  • Note: Review of data submissions will be guided by best practices established for the database and will include performing basic accuracy and reproducibility assessments using the data.
• Project management for conference calls and meetings that are technical and/or scientific in nature, including scheduling, drafting agendas, creating slides and other meeting materials, participating in the calls, following up on action items, and writing meeting summaries.
• General project management, including tracking and following up on the status of datasets, requests for the data, scientific papers drafted with the data, database modifications, milestones in the integration with other platforms, and other items.
• Coordinating accurate review of data, requests, and publications by various internal and external entities.
• Independently drafting periodic reports that include abstracting information from various databases and scientific manuscripts, as well as manipulating data to present statistics clearly and accurately.
• Writing Standard Operating Procedures (SOPs) and workflows to establish new processes. Refining and streamlining these SOPs as processes are implemented and later updated.
• Creating and maintaining various project documents such as tracking sheets, data requester instructions, data provider guides, etc.
• Reviewing, processing, and approving requests for data and processing publications resulting from use of the data.
• Understanding, abstracting, synthesizing, and reviewing information from cancer clinical trial protocol documents, cancer clinical trial manuscripts, literature searches, and cancer clinical trial databases.
• Performing User Acceptance Testing (UAT), documenting findings, and assessing the quality of subsequent software changes.
• Fielding questions sent to project email mailboxes as needed.
• Independently anticipating and prioritizing next steps needed to advance projects towards their goals.
• Assisting with the development, review, and execution of agreements documents, such as Data Use Agreements (DUAs), Data Transfer Agreements (DTAs), Confidential Disclosure Agreements (CDAs), and Conflict of Interest (COI) forms as needed.

• Bachelor's degree required.
• Attention to detail.
• Experience with patient-level data preferred; familiarity with such data at minimum required.
• Knowledge of Microsoft Excel, SAS, PubMed, Endnotes and Visio is desirable.
• Knowledge of data science, biostatistics, biology, and oncology is desirable.
• Strong writing skills, including the ability to write succinctly, articulately, and professionally.
• Strong oral and written communication skills.
• Ability to work in a team, but in an independent fashion. Projects involve large groups of researchers across several sites and this individual will work within a complex data workflow with many moving parts. Ability to communicate well with team members is a must.
• Ability to set own deadlines and work efficiently within an independent work environment.
• Project management skills, including ability to anticipate and prioritize next steps without direction.
• Flexibility and the ability to switch among competing tasks and priorities.
• Ability to format documents for consistent, professional appearance.

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:

• 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 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.