Clinical Data Repository Manager/Project Manager - Remote

Location
Rockville, Maryland
Salary
Competitive
Posted
May 23, 2022
Closes
Jun 04, 2022
Ref
3276
Function
Management
Industry
Science
Hours
Full Time
Cinical Data Respository Manager/Project Manager

U.S. Remote Worker

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.

Responsibilities
  • Writing Standard Operating Procedures (SOPs) and workflows to establish new processes. Refining and streamlining these SOPs as processes are implemented.
  • Creating and maintaining various project documents such as tracking sheets, data requester instructions, data provider guides, etc.
  • 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.
  • 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.
  • Fielding questions sent to project email mailboxes as needed.
  • Coordinating scientific working groups and committees of cancer researchers.
  • Writing scientific summaries of calls/meetings pertaining to cancer research. An ability to identify and succinctly list the action items stemming from these calls/meetings is key.
  • Scheduling conference calls and meetings.
  • Following up on action items, including sending reminders, to keep projects on track. Good project management skills are key.
  • Independently anticipating and prioritizing next steps needed to advance projects towards their goals.
  • Organizing and preparing materials for conference calls and in-person meetings of cancer researchers.
  • 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.



Experience
  • Master's degree preferred, Bachelor's degree at minimum required.
  • Attention to detail.
  • Experience with patient-level data preferred; familiarity with such data at minimum required.
  • Knowledge of Microsoft Excel, SAS, PubMed, and Endnotes is desirable.
  • Knowledge of data science and biostatistics is desirable.
  • Strong writing skills, including the ability to write succinctly, articulately, and professionally.
  • Strong oral and written communication skills.
  • Knowledge of biology.
  • 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.
  • Ability to mentor other team members.


Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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:
  • Unlimited Approved Leave
  • Tuition Reimbursement
  • 401k & Profit-Sharing 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 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.

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