The Life Sciences division at Leidos is seeking a Clinical Trial Manager. This position is responsible for providing guidance and support to clinical operations for assigned clinical studies including project planning, review and approval of protocol related study documents, and ensuring that the trials are conducted in a timely fashion and in a manner complaint with SOPs, ICH/GCP/regulatory guidelines. The Clinical Trial Manager will serve as one of the points of contact for customer interface and will collaborate with all stakeholders to achieve clinical program goals and objectives.
Provide comprehensive support of all operational aspects of the clinical trials for which they are responsible, including the review and approval of protocols and study related documents (e.g., Regulatory Binder, Work Instructions, CRF Completion Guidelines, etc.).
Effectively support the subcontracted clinical teams for assigned studies and delegate appropriate tasks, assignments, and responsibilities to ensure trial success.
Support the clinical operations team from study start up to study close out.
Identify, communicate, and find resolutions for all protocol related deviations and violations.
Oversee the monitoring, implementation and corrective actions for study progress using available study management tools.
Identify and develop risk management and contingency plans.
Provide appropriate training for team members to ensure consistent execution of all study related activities.
Drive the cross-functional team members to ensure timely creation of protocols and study deliverables.
Participate in CRO/vendor selection process for outsourced activities as applicable.
Manage CRO interactions, including sponsor oversight of relevant activities (study management, monitoring, site management, data management, and safety assessments) as applicable.
Monitor all study progress. Ensure compliance with applicable regulations and guidelines, and review monitoring reports for data quality. Identify potential study issues and recommend/implement solutions.
Share and promote the best practices within the teams to enhance performance.
Maintain awareness of the pertinent elements of contract and scope of work, and communicate status updates to the Clinical Project Manager and Program Manager.
Manage multiple teams; will work in high-pressure production environments and deliver outstanding products for multiple stakeholders under tight deadlines and constraints.
Assist in the preparation of written communications, plans, reports, briefings, and briefing materials as required by the contract to meet reporting requirements.
Support team in clinical data transfer for delivering study data to sponsor or vendors.
Provide support to the Clinical Project Manager and perform as back-up for specific activities (including the attendance of sponsor’s meetings to provide updates).
Assist 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.
May represent Leidos Life Sciences at business development related meetings.
Basic Qualifications / Skills:
Bachelor’s degree in the biological sciences or related disciplines in the natural science/health care field.
Minimum of 4-8 years of industry experience in a clinical trial environment.
Demonstrated experience with clinical trial management practices with knowledge of basic data management process.
Experience in utilizing software related to database management software systems.
Excellent understanding of clinical trial process across phases of clinical trials (Phase I – Phase IV).
Experience with Metadata Rave, Oracle Clinical, or other data management systems.
Experience with site start-up activities from site selection/recommendation through site-activation.
Understanding of 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.
Demonstrated 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.
Preferred Qualifications / Skills:
Experience in remote clinical trial management preferred.
Knowledge of clinical data, and International Council for Harmonization (ICH)/Good Clinical Practices (GCP), and knowledge of medical terminology preferred.
Pay Range:Pay Range $78,000.00 - $120,000.00 - $162,000.00
The Leidos pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
Leidos is a Fortune 500® technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, civil, and health markets. The company’s 47,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $14.4 billion for the fiscal year ended December 30, 2022. For more information, visit www.Leidos.com.
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