Data Repository Manager and Data Reviewer
- Employer
- The Emmes Company, LLC
- Location
- Rockville, Maryland
- Salary
- Competitive
- Posted
- Mar 18, 2023
- Closes
- Apr 17, 2023
- Ref
- 3728
- Function
- Management
- Industry
- Science
- Career Level
- Experienced (Non-Manager)
- Hours
- Full Time
Data Repository Manager and Data Reviewer
US 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 Data Repository Manager and Data Reviewer to assist with a range of data-related activities in support of a large data repository for cancer clinical trials, particularly the review and quality assurance of submitted datasets.
Primary Responsibilities
· Coordinating data submissions into the repository from multiple cancer clinical trials 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.
o Note: Review of data submissions will be guided by best practices established for the database and will include performing accuracy and reproducibility assessments using the data.
o Review of datasets submitted to the repository will be a major responsibility of this position. Dataset review includes careful review of datasets and data dictionaries to identify errors and inconsistencies that need correcting by the submitting group.
o Understanding, abstracting, synthesizing, and reviewing information from cancer clinical trial protocol documents, cancer clinical trial manuscripts, literature searches, and cancer clinical trial databases, as well as using the information to review data.
· Reviewing, processing, and approving requests for data and processing publications resulting from use of the data.
· Following up on action items, including sending reminders, to keep projects on track.
· 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.
· Writing Standard Operating Procedures (SOPs) and workflows to establish new processes. Refining and streamlining these SOPs as processes are implemented.
· Independently anticipating and prioritizing next steps needed to advance projects towards their goals.
· Creating and maintaining various project documents such as tracking sheets, data requester instructions, data provider guides, etc.
· Assisting with ad hoc tasks that support the activities listed above.
Secondary Responsibilities
· Fielding questions sent to project email mailboxes as needed.
· Coordinating with cancer researchers as needed to advance the project."
· 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.
Experience
· Bachelor's degree is required, Master's degree preferred.
· Attention to detail.
· Experience with patient-level data preferred; familiarity with such data at minimum required.
· An understanding of clinical research trials is a requirement.
· Knowledge of Microsoft Excel, SAS, PubMed, and Endnotes is desirable.
· Knowledge of cancer research, data science and biostatistics is desirable.
· Strong understanding of the types of data variables and data values involved in clinical studies, particularly in cancer, is preferred.
· 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.
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!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - The Emmes Company, LLC
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.
Emmes only requires all US new hires in the following job categories to be fully vaccinated before their first day of employment: (i) Clinical Research Associates (CRAs), (ii) Associate CRAs, and (iii) all CRA line managers. 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.
US 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 Data Repository Manager and Data Reviewer to assist with a range of data-related activities in support of a large data repository for cancer clinical trials, particularly the review and quality assurance of submitted datasets.
Primary Responsibilities
· Coordinating data submissions into the repository from multiple cancer clinical trials 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.
o Note: Review of data submissions will be guided by best practices established for the database and will include performing accuracy and reproducibility assessments using the data.
o Review of datasets submitted to the repository will be a major responsibility of this position. Dataset review includes careful review of datasets and data dictionaries to identify errors and inconsistencies that need correcting by the submitting group.
o Understanding, abstracting, synthesizing, and reviewing information from cancer clinical trial protocol documents, cancer clinical trial manuscripts, literature searches, and cancer clinical trial databases, as well as using the information to review data.
· Reviewing, processing, and approving requests for data and processing publications resulting from use of the data.
· Following up on action items, including sending reminders, to keep projects on track.
· 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.
· Writing Standard Operating Procedures (SOPs) and workflows to establish new processes. Refining and streamlining these SOPs as processes are implemented.
· Independently anticipating and prioritizing next steps needed to advance projects towards their goals.
· Creating and maintaining various project documents such as tracking sheets, data requester instructions, data provider guides, etc.
· Assisting with ad hoc tasks that support the activities listed above.
Secondary Responsibilities
· Fielding questions sent to project email mailboxes as needed.
· Coordinating with cancer researchers as needed to advance the project."
· 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.
Experience
· Bachelor's degree is required, Master's degree preferred.
· Attention to detail.
· Experience with patient-level data preferred; familiarity with such data at minimum required.
· An understanding of clinical research trials is a requirement.
· Knowledge of Microsoft Excel, SAS, PubMed, and Endnotes is desirable.
· Knowledge of cancer research, data science and biostatistics is desirable.
· Strong understanding of the types of data variables and data values involved in clinical studies, particularly in cancer, is preferred.
· 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.
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!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - The Emmes Company, LLC
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.
Emmes only requires all US new hires in the following job categories to be fully vaccinated before their first day of employment: (i) Clinical Research Associates (CRAs), (ii) Associate CRAs, and (iii) all CRA line managers. 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.