The Government Health and Safety Solutions Operation is seeking a Deputy Project Manager, contingent upon contract award, in Bethesda, MD.
This position is responsible for leading Clinical Data Management activities and will serve as one of the primary points of contact for customer interface for a large Clinical Data Management contract with the National Institutes of Health.
- Maintains awareness of the pertinent elements of contract and scope of work, and communicates status updates to the Project 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 data management plans and data capture; including the auditing of clinical sites for quality assurance in data capture;
- Manages subcontracts related to data management, provides oversight and maintains proficiency in data management systems and processes;
- Participates/leads internal and external meetings;
- Participates in internal/external audits as required;
- Ensures that data from external databases/datasets such as central and/or local laboratory data, pharmacokinetic (PK) data, or Institutional Review Board (IRB) data are consistent with data reported, uses specified processes to document and query any such discrepancies found with the appropriate party;
- Provides oversight for data cleaning and/or status reports;
- Liaises with other groups such as the Central Institutional Review Board (CIRB), and Clinical Operations; assists in the development and/or maintenance of study rosters, patient enrollment rosters, drug distribution, site reimbursement, and auditing;
- Supports patient enrollment and randomization; supports Investigator regulatory credentialing; and monitoring of patient accrual;
- Creates ad-hoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing;
- Perform post-migration testing on screens, edit checks, matrices and role changes as required;
- 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;
- Collaborates with other data management teams to provide tables, listings, and figures (TLFs) for various studies; produces study metrics and other ad hoc clinical data reports as needed by the customer;
- Creates, updates, and/or reviews study-specific documents such as CRF/eCRF Data Management Plans (DMP), data import/export agreements, CRF/eCRF Completion Guidelines;
- Supports team in clinical data transfer for delivering study data to sponsor or vendors;
- Provides support to the Project Manager and is back up for specific activities (including the attendance of sponsor’s 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
- Understands the coding process;
- Understands the purpose of interim, dry run, data cut;
- Develops protocol specific plans, and trains project team in project specific requirements;
- Supports electronic data capture (EDC) training to internal and external team members;
- Serves as a platform or process-specific subject matter expert (SME);
- May represent the department at business development related meetings.
- BA/BS degree in the biological sciences or related disciplines in the natural science/health care field;
- Minimum of 7+ years of industry experience in a clinical trial environment;
- Excellent experience with data management practices and relational database management software systems preferred;
- Excellent understanding of clinical trial process across Phase II-IV;
- Experience in clinical data management in at least one of the following trial types: oncology, bioequivalence, advanced therapy products, or vaccines;
- Experience with Metadata Rave, Oracle Clinical, or other 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 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.
Must be able to obtain a Public Trust Clearance
External Referral Bonus:Ineligible
Potential for Telework:No
Clearance Level Required:Public Trust
Scheduled Weekly Hours:40
Job Family:Health Product Development
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.
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