EMMES Corporation
Data Manager
EMMES Corporation, Rockville, Maryland, us, 20849
Overview
Principal Data Manager
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 Principal Data Manager provides data management leadership and subject matter expertise for research studies. The Principal Data Manager works as an integral part of a cross-functional team through the lifecycle of the research study from design through final analysis and study closeout. The Principal Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and serves as an expert consultant to cross-functional internal and external teams on all aspects of data collection and data management best practices.
Responsibilities
Serves as lead point of contact for both internal cross-functional teams and external contacts on the design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) systemProvides oversight for creation and/or review of study-specific electronic or paper Case Report Forms (CRFs) using strong technical knowledge, protocol-specific information, and departmental standards; ensures timely development and implementation of CRFs; serves as project or therapeutic area resource for design and development challengesProvides oversight for determining data collection requirements at a project or therapeutic area level, utilizing extensive experience to drive developmentResponsible for analyzing potential complex data management issues/risks and recommending/implementing solutionsApproves/reviews clinical data management plans or develops key study document templates (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User's Guide, EDC Training and Certification Documents)Leads data reviews with data management team to ensure accuracy and consistency and creates corrective action plan as necessaryProvides oversight of training documentation and system user access; may serve as resource for complex troubleshootingMentors DM staff in general team leadership skills, project management skills, internal Emmes DM processes, and for project or therapeutic area specific tasksAuthors, reviews, and/or edits written summaries of data reports; presents data as applicableProvides oversight for the management and reconciliation processes of the data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sourcesMay be required to facilitate or present at meetings, conferences, and other events representing Emmes, including job fairs or other external eventsDevelops and implements data validation processes; ensures the integrity of data, providing recommendations for correction action when necessaryMay provide direct line support for DM staff. For direct reports:
Collaboratively conducts performance and compensation review activities with the applicable project leader or designeeResponsible for addressing employee relations issues and resolving problemsEnsures DM salary and bonus equity compliance o Approves timesheets, expense reports, and leave requests
Other duties as assignedQualifications
Bachelor's degree, preferably in a public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degreeIncumbent typically will possess at least 8 years of progressive data management experience (or Master's degree with 6 years) and strong understanding of clinical research and/or data management processesKnowledge of GCP and applicable regulatory guidelinesExperience in pharmaceutical industry and/or contract research organization preferredExperience in clinical electronic data capture (EDC) systems preferredKnowledge of Microsoft Office suite is essentialGood analytical, interpersonal, and organizational skillsExcellent verbal and written communication skills with ability to inform and collaborateMust have a good understanding of clinical database structures and data management processesStrong attention to detail, adaptable, and flexibleSelf-motivated and proactive with demonstrated ability to work independentlyWhy 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 OffTuition Reimbursement401k Retirement PlanWork From Home Anywhere in the USMaternal/Paternal LeaveCasual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
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.
#LI-Remote
Principal Data Manager
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 Principal Data Manager provides data management leadership and subject matter expertise for research studies. The Principal Data Manager works as an integral part of a cross-functional team through the lifecycle of the research study from design through final analysis and study closeout. The Principal Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and serves as an expert consultant to cross-functional internal and external teams on all aspects of data collection and data management best practices.
Responsibilities
Serves as lead point of contact for both internal cross-functional teams and external contacts on the design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) systemProvides oversight for creation and/or review of study-specific electronic or paper Case Report Forms (CRFs) using strong technical knowledge, protocol-specific information, and departmental standards; ensures timely development and implementation of CRFs; serves as project or therapeutic area resource for design and development challengesProvides oversight for determining data collection requirements at a project or therapeutic area level, utilizing extensive experience to drive developmentResponsible for analyzing potential complex data management issues/risks and recommending/implementing solutionsApproves/reviews clinical data management plans or develops key study document templates (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User's Guide, EDC Training and Certification Documents)Leads data reviews with data management team to ensure accuracy and consistency and creates corrective action plan as necessaryProvides oversight of training documentation and system user access; may serve as resource for complex troubleshootingMentors DM staff in general team leadership skills, project management skills, internal Emmes DM processes, and for project or therapeutic area specific tasksAuthors, reviews, and/or edits written summaries of data reports; presents data as applicableProvides oversight for the management and reconciliation processes of the data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sourcesMay be required to facilitate or present at meetings, conferences, and other events representing Emmes, including job fairs or other external eventsDevelops and implements data validation processes; ensures the integrity of data, providing recommendations for correction action when necessaryMay provide direct line support for DM staff. For direct reports:
Collaboratively conducts performance and compensation review activities with the applicable project leader or designeeResponsible for addressing employee relations issues and resolving problemsEnsures DM salary and bonus equity compliance o Approves timesheets, expense reports, and leave requests
Other duties as assignedQualifications
Bachelor's degree, preferably in a public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degreeIncumbent typically will possess at least 8 years of progressive data management experience (or Master's degree with 6 years) and strong understanding of clinical research and/or data management processesKnowledge of GCP and applicable regulatory guidelinesExperience in pharmaceutical industry and/or contract research organization preferredExperience in clinical electronic data capture (EDC) systems preferredKnowledge of Microsoft Office suite is essentialGood analytical, interpersonal, and organizational skillsExcellent verbal and written communication skills with ability to inform and collaborateMust have a good understanding of clinical database structures and data management processesStrong attention to detail, adaptable, and flexibleSelf-motivated and proactive with demonstrated ability to work independentlyWhy 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 OffTuition Reimbursement401k Retirement PlanWork From Home Anywhere in the USMaternal/Paternal LeaveCasual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
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.
#LI-Remote