To our valued Leidos candidates:

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Job #: R-00040716
Location: Bethesda, MD
Category: Proj and Prog Management
Schedule (FT/PT): Full Time
Travel Required: Yes, 10% of the time
Shift: Day
Potential for Telework: No
Clearance Required: Public Trust
Referral Eligibility: Ineligible
Group: Health

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Description

Job Description:

This position is responsible for leading Information Management activities and will serve as one of the primary points of contact for customer interface for a large Clinical Trials Information Management contract with the National Institutes of Health (NIH). 

This position is contingent on contract award

Primary Responsibilities:

  • Maintain awareness of the pertinent elements of contract and scope of work, and communicates status updates to the Program Manager;
  • Manage multiple teams, will work in high-pressure production environments and deliver outstanding products for multiple stakeholders under tight deadlines and constraints;
  • Be responsible for removing impediments from teams while promoting self-management and improving standards of work;
  • Assist in the preparation of written communications, plans, reports, briefings and briefing materials as required by the contract to meet reporting requirements;
  • Evaluates, monitors, and ensures compliance with laws, regulations, policies, standards, or procedures associated with all aspects of the project;
  • Reviews and supports the adherence to requirements outlined in information management plans and data capture; including the auditing of clinical sites for quality assurance in data capture, data extractions, data analysis and data synthesis;
  • Manages subcontracts related to information management, provides oversight and maintains proficiency in clinical trials information management systems and processes;
  • Participates/leads internal and external meetings;
  • Participates in internal/external audits as required;
  • Provides oversight for quality assurance, and weekly and monthly progress and/or status reports;
  • Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review;
  • Assist in the organization of working groups with stakeholders to develop collaborative improvements and solutions to existing clinical databases;
  • Provide technical advice to NCI-sponsored investigators and their teams in the development of new Common Data Elements (CDE) as the scientific and/or trial need arises.
  • Lead teams in:
    • Conducting literature searches from available databases (e.g., CANCERLIT, MEDLINE, and PubMed) and preparing tables, data synthesis, and other written material for presentation, publications and/or distribution.
    • Organizing and attending governance and scientific meetings and prepare detailed minutes or summaries of these meetings within the time frame specified by the contract.
    • Developing and maintaining websites and/or databases for data sharing activities.
    • Designing data collection instruments (including databases) and developing data collection procedures for use in analysis of NCI-sponsored cancer clinical trials.
    • Abstracting, compiling, collating, and analyzing data utilizing a variety of resources available within and outside of NCI.
    • Assisting in the review process for clinical trials/ research proposals.
  • Provides support to the Program Manager and is back up for specific activities (including the attendance of customer meetings to provide updates);
  • Assists in the operational maintenance and/or integration of the customer’s enterprise systems and applications;
  • Provide travel and meeting logistical support, as needed, for face-to-face meetings to discuss operations, including identification of hotel, developing agenda, arranging teleconference and audiovisual support, and securing conference rooms;
  • Serves as a platform or process-specific subject matter expert (SME);
  • May represent the company at business development related meetings.

Basic Qualifications:

BA/BS or equivalent experience and 8+ years of prior relevant experience or Masters with 6+ years of prior relevant experience. Generally has 4+ years of experience supervising or leading teams or projects.

  • Minimum of 7+ years of project management experience;
  • Minimum of 7+ years of industry experience in bioinformatics supporting a clinical trial environment;
  • Excellent experience with data management practices, information models and data standards for clinical trial data, oncology data, and genomics data.
  • Good understanding of clinical trial processes across Phase II-IV;
  • Experience in clinical data management for oncology clinical trials;
  • Experience with Medidata Rave, Oracle Clinical, or other clinical trials data management systems;
  • Knowledge of clinical data, and International Council for Harmonization (ICH)/Good Clinical Practices (GCP), and knowledge of medical terminology preferred;
  • Experience with site start-up activities from site selection/recommendation through site-activation;
  • Experience identifying and evaluating fundamental issues/gaps pertaining to site start-up, successful patient enrollment, data interpretation of complex issues, and patient randomization;
  • Understands regulatory practices and governance, including the regulatory roles of the IRB and Ethics Committees;
  • Project management experience;
  • Good vendor management skills;
  • Strong organizational skills with proven ability to handle multiple tasks;
  • Excellent communication, presentation and interpersonal skills, quality driven in all managed activities;
  • Strong ability to analyze a large volume of documents and data and make appropriate decisions;
  • Strong negotiating skills;
  • Demonstrate an ability to provide quality feedback and guidance to peers;
  • Contribute to a training and quality assurance plan, ability to draft standard operating procedures related to data management and study start up;
  • Leadership skills; ability to teach/mentor team members.

Nice-to-Have Qualifications

  • Prior experience leading or contributing to projects at NIH;
  • Prior experience using the NIH metadata management systems to create and maintain Common Data Elements;
  • Experience designing relational database management software systems;
  • PMP® Certification (or commitment to get the certification within one year after hire).

External Referral Bonus:

Ineligible

Potential for Telework:

No

Clearance Level Required:

Public Trust

Travel:

Yes, 10% of the time

Scheduled Weekly Hours:

40

Shift:

Day

Requisition Category:

Manager

Job Family:

Proj and Prog Management

Leidos

Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $10.19 billion for the fiscal year ended December 28, 2018. For more information, visit www.Leidos.com.

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here.

Securing Your Data

Leidos will never ask you to provide payment-related information at any part of the employment application process. And Leidos will communicate with you only through emails that are sent from a Leidos.com email address. If you receive an email purporting to be from Leidos that asks for payment-related information or any other personal information, please report the email to [email protected].

Commitment to Diversity

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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