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
- 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.
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.
- 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).