Data Manager (Experienced)

Location
Rockville, Maryland
Salary
Competitive
Posted
Apr 05, 2019
Closes
May 05, 2019
Ref
2036
Function
Management
Industry
Science
Hours
Full Time
The Emmes Corporation, established in 1977, is a women-owned private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

This position will provide data management support for studies on the AIDS Malignancy Consortium (AMC) research team. The AMC group focuses on innovative Phase I through III clinical trials for AIDS-related cancers. The AMC's mission is to investigate new treatment and prevention interventions for malignancies in people living with HIV. The AMC group provides support for more than 20 clinical research studies both domestically and internationally. The AMC is a full-service project that provides multi-faceted support such as data management, protocol monitoring, adverse event review and reporting, protocol development, and regulatory document tracking and submission.

The Data Manager is responsible for completing study and site-specific data management activities in accordance with Good Clinical Practices and other relevant guidelines. The Data Manager works as an integral part of a multidisciplinary team through the lifecycle of the clinical study from study design through final analysis and study closeout. The Data Manager is responsible for the completeness and accuracy of the study data in the electronic database. Data management deliverables include electronic case report forms, data integrity checks, data collection guidelines, and user's guides. The Data Manager also performs quality control of study-specific reports.

Responsibilities
  • Work in a team environment to design, develop and manage clinical trial data systems, utilizing strong data management and computing skills
  • Design, build, test and validate electronic case report forms (eCRFs)
  • Develop, generate, manage, and distribute data queries and reports to clinical sites
  • Creates and implements validation processes for multiple methods of data collection
  • Performs Oversee internal audits and participates in other project and corporate quality assurance activities
  • Contribute to the quality and accuracy of various reports for the duration of the trial
  • Ensure adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining data integrity and quality throughout a clinical study protocol
  • Accountable for the execution and overall quality of data management activities and deliverables
  • Act as the Emmes point of contact for the study sponsor and the collaborating investigators to initiate and support data management activities for clinical protocols
  • Provide guidance, training, and supervision to study data managers
  • Lead development of the electronic case report forms and the study database
  • Review data edit checks and queries produced by the study data managers
  • Provide critical review of study materials, including the study protocol, manual of procedures, and statistical analysis plan
  • Coordinate and contribute to generation of study reports (safety, regulatory, and final)
  • Review and contribute to manuscripts
  • Key role as team leader in project planning, implementation, problem solving, tracking milestones and deliverables

Experience
  • Bachelor's degree (scientific discipline preferred) and 6 years of related experience or master's degree with 4 years of related experience and demonstrated working knowledge of scientific principles appropriate to the position.
  • Strong data management/computer skills; prior experience with CRF design, EDC systems, or other web based data collection systems helpful
  • Excellent oral and written communication skills
  • Skills in prioritization, organization, and time management
  • High attention to detail, ability to multi-task and collaborative
  • Knowledge of Good Clinical Practices and Human Subjects Protection regulations, as they relate to data management
  • Familiarity with Good Clinical Data Management Practices
  • Demonstrated understanding of data query and reconciliation process
  • Strong collaborator and able to work well as part of a team
  • Prior experience in mentoring/training new or junior staff is a plus


CONNECT WITH US!!

Follow us on Twitter - @EMMESCorp

Find us on LinkedIn - The EMMES Corporation

The Emmes Corporation 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.

Similar jobs

More searches like this