Clinical Research Manager – Cure Sickle Cell Initiative (CSCI)

Location
Rockville, Maryland
Salary
Competitive
Posted
Oct 05, 2019
Closes
Oct 18, 2019
Ref
2265
Industry
Science
Hours
Full Time
The Emmes Company LLC, established in 1977, is a privately-owned Contract Research Organization (CRO). Headquartered in Rockville, Maryland Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, 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.

Project

The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership in research, training, and education to prevent and treat heart, lung, blood and sleep disorders. The NHLBI is convening a Cure Sickle Cell Disease Initiative (CureSCi), aimed at finding innovative ways to support discovery and development of efficacious genetic therapeutic approaches and bring them to scale in clinical populations to accelerate finding curative treatments for Sickle Cell Disease (SCD). The NHLBI is working with The EMMES Corporation to establish a Coordinating Center (CC) for the CureSCi and to engage key staff of this Initiative.

Responsibilities
  • Serves as the Data Strategy Subcommittee Lead to oversee the Emmes Coordinating Center's Common Data Element (CDE) team development, curation, and distribution of CDEs for the CureSC Initiative
  • Serves as a member of the CureSC Initiative's Data Consortium to collaborate with Data Consortium teams on data elements and data harmonization
  • Collaborates with NHLBI, CureSC Initiative and Data Consortium leads in the stewardship of metadata and data for the Initiative
  • Serves as the Scientific Subcommittee Lead and coordinates and directs activities of cross-functional team members for the completion of project deliverables within this aspect of the CureSCi
  • Notifies the PI/PD/PM of deviations from the timelines and proposes revised timelines or corrective actions
  • Serves as the Emmes project expert on assigned protocols/studies/activities and demonstrates ability to integrate, summarize and communicate project activities to internal and external teams
  • Communicates and interacts with Emmes project staff regarding project requirements and deliverables. Communicates with and updates project team members on all relevant issues
    Represents the CureSCi at NHLBI meetings and other client-directed activities specifically related to the Data Strategy and Scientific Subcommittees
  • Fosters a collaborative and respectful relationship with NHLBI, other external stakeholders and Emmes project team members. Earns the trust and respect of internal and external colleagues

Routine Tasks include:
  • Oversees the coordination of existing (and yet-to-be-identified) Scientific Subcommittees and working groups, which include the Scientific Review Committee, Assay Development SubC, Gene Editing/Gene Therapy SubC, Clinical Trial Design SubC, Apheresis working group, and Ophthalmology working group
  • Coordination includes attending and scheduling all Scientific calls/meetings, preparing agendas with input from Chairs and NHLBI, reviewing meeting minutes, coordinating with group Chairs, and distributing meeting materials
  • Preparing for monthly Scientific Review Committee calls, which involves preparing a conflict of interest list for reviewers, collecting pre- and post- conflict of interest statements, collecting consultant agreements, preparing quarterly honorarium payments for reviewers, corresponding with SRC reviewers and applicants, alerting NHLBI when preliminary applications are available for review in the application system, and drafting executive summaries of the applications
  • Attends project Executive and Steering Committee calls with NHLBI
  • Attends and participates in weekly internal staff meetings for project updates and tasks assignments
  • Manage action items for Scientific Subcommittees
  • Assists in the preparation of project-required reports
  • Ensures adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining data integrity and quality throughout the project Represents Common Data Elements (CDE) and Data Consortium activities for Coordinating Center internal and external meetings and reports Attends Data Consortium Scrum calls and in-person meetings, providing updates on the status of CDE development, curation and distribution Attends Data Elements Working Group (DEWG) calls and helps coordinate data element development and data harmonization across the Initiative Oversees CDE and IT support for the development and maintenance of the Data Consortium pages and the CDE Portal as part of the Coordinating Center's role in supporting the Initiative's curesickle.org website Ongoing familiarization with relevant literature and research for creating data elements and conducting data harmonization in the Initiative Provides assistance in note taking and minutes as required for external calls, meetings, and conferences

Experience, Competencies, and Education
  • Bachelor's degree with a minimum of 10 years of related experience and demonstrated working knowledge of scientific principles appropriate to the position
  • Knowledge of clinical research including the critical elements for the development and execution of clinical trials or research studies
  • Experienced, effective project leadership within one of the technical/specialized areas at Emmes
  • Strong skills in prioritization, organization, problem solving, decision-making, time management, mentoring and planning
  • Good interpersonal skills and ability to deal with staff at all levels with sensitivity and tact
  • Ability to foster concepts of teamwork, research integrity, ethical conduct and personal responsibility
  • Ability to self-direct and work independently and in a complex team environment
  • Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues
  • Prior knowledge of cellular & genetic therapy is preferable
  • Broad familiarity with the purpose, implementation, and tools for Common Data Elements (CDEs) at the NIH and the NLM
  • Broad knowledge of CDE development and curation processes employed at Emmes, especially for NINDS and the CureSC Initiative
  • Broad familiarity with established data element collections for Sickle Cell Disease or in general (e.g., PhenX, ASQC-Me, PROMIS)
  • Experience in leading small project teams to achieve project objectives in a timely manner
  • Experience in working with external SMEs (i.e., investigators and physicians) in developing standardized data collection processes and tools
  • Broad familiarity with processes at Emmes for developing and maintaining Drupal-based project websites
  • Broad knowledge of standardized processes and collections employed by Data Consortium teams will be acquired (e.g., PhenX data element development, Maelstrom Research guidelines for data harmonization, Trans-Omics for Precision Medicine (TOPMed) sponsored by NHLBI, and various extant and active data collections with Sickle Cell patients or contemporaneous controls)

CONNECT WITH US!!

Follow us on Twitter - @EMMESCorp

Find us on LinkedIn - The EMMES Company

The Emmes Company 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