Clinical Trial Manager
Do you have experience in clinical trial operations, site management, regulatory affairs, or laboratory management? Do you have experience supporting international clinical trials? Are you interested in planning and implementing cutting-edge research in support of the US Government and private sponsors?
The Life Sciences Division at Leidos Health currently has an opening for a Clinical Trial Manager based in Frederick, Maryland.
• Responsible for supporting the planning, oversight and implementation of clinical trials. Simultaneously support multiple trials conducted by various sponsors, vendors, and other stakeholders.
• Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
• Works with multiple contract research organizations (CROs) to communicate detailed timelines and ensure that transferred obligations and performance expectations are met.
• Creates and reviews site feasibility assessments required for study participation.
• Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations.
• Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to CRO, Program Manager, and/or clients.
• Prepares metrics and updates to key deliverables for management.
• Assists in resolution of routine study questions from CROs or clinical trial sites in adherence to ICH GCP and the study protocol.
• Participates in the development, review and implementation of departmental SOPs and processes.
• Participates in CAPA development and tracking
• Supports site initiation visits and ascertain site readiness for study start
• Maintains oversight of protocol implementation by reviewing progress reports from CROs, monitoring reports, and audit reports as needed.
• Supports data management related activities, including review of data management plans and follow-up of data management issues identified through monitoring.
• Manages sites in meeting subject enrollment targets to meet contractual obligations
• Provides site training and guidance in reference to protocol compliance.
• Assists in daily oversight of CROs to ensure successful clinical trial implementation and execution.
• Manages site relationships to ensure positive interactions through routine site contact.
• BS Degree in Nursing, Life Sciences, or related health field and 4 - 8 years relevant experience.
• Experience supporting INTERNATIONAL clinical trials.
• Knowledge of clinical trial fieldwork concepts and practices, specifically international clinical research guidelines related to site management requirements
• Ability to apply different standards related to clinical research (SOPs, GCP, ISO, ICH, FDA, etc.) as needed
• Extensive knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.
• Strong analytical and problem solving skills
• Attention to detail
• Experience overseeing subcontractors such as CROs, central labs, and clinical sites
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills
• Ability to build constructive and effective relationships; use diplomacy and tact.
• Ability to interpret regulatory and contractual documents
• Experience with regulatory audits.
• Experience with infectious disease or vaccine trials.
• Proficient in Spanish or Portuguese.
• Willingness to travel up to 25%.
• Certified Clinical Research Associate or Certified Clinical Research Professional.
• Experience with Good Laboratory Practice or Good Manufacturing Practice.
• Experience supporting US Govt-funded trials.
• Knowledge of and experience in trial protocol development.
• Certified Project Management Professional.
*Summer referral eligible
Leidos is a global science and technology solutions 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 pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.