Overview:
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 Clinical Data Manager provides data management leadership and subject matter expertise for research studies. The Principal Clinical 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 Clinical 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) system.
Provides 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 challenges.
Provides oversight for determining data collection requirements at a project or therapeutic area level, utilizing extensive system experience to drive development.
Responsible for analyzing potential complex data management issues/risks and recommending/implementing solutions.
Approves/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 necessary
Provides oversight of training documentation and system user access, may serve as resource for complex troubleshooting.
Mentors DM staff in general team leadership skills, project management skills, internal Emmes DM processes, and for project or therapeutic area specific tasks.
Authors, reviews, and/or edits written summaries of data reports, presents data as applicable CORPORATE CONFIDENTIAL
Provides 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 sources
May be required to facilitate or present at meetings, conferences, and other events representing Emmes; including job fairs or other external events.
Develops and implements data validation processes. Ensures the integrity of data, providing recommendations for corrective action when necessary.
May provide direct line support for DM staff. For direct reports:
Collaboratively conducts performance and compensation review activities with the applicable project leader or designee Responsible for addressing employee relations issues and resolving problems
Ensures DM salary and bonus equity compliance o Approves timesheets, expense reports, and leave requests
Approves timesheets, expense reports, and leave requestsQualifications:
Bachelor's degree in scientific discipline preferred with a working knowledge of the clinical/scientific terminology and methods.
Incumbent typically will possess at least 8 years data management experience
Preferred MS in scientific discipline accompanied with basic understanding of the clinical development and data management processes with 6 years progressive experience working in a clinical research environment
Knowledge of MS Excel, Word, Access, and PowerPoint is essential.
Good analytical, interpersonal, and organizational skills,
Excellent verbal and communication skills Must have a good understanding of clinical database structures, and data management processes.
Stong attention to detail and flexible
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