Clinical Trial Manager
Leidos

Frederick, Maryland

This job has expired.

Job Info

Description

Job Description:

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.

Primary Responsibilities:

Provide comprehensive support of all operational aspects of the clinical trials for which he/she is responsible for, 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;
Maintains awareness of the pertinent elements of contract and scope of work, and communicates 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;
Evaluates, monitors, and ensures compliance with laws, regulations, policies, standards, or procedures associated with all aspects of the project;
Participates/leads internal and external meetings;
Participates in internal/external audits as required;
Provides oversight for data cleaning and/or status reports;
Liaises with remote site staff and 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;
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;
Supports team in clinical data transfer for delivering study data to sponsor or vendors;
Provides support to the Clinical 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
May represent Leidos Life Sciences at business development related meetings.

Basic Qualifications:

BA/BS degree in the biological sciences or related disciplines in the natural science/health care field;
Minimum of 3-5+ years of industry experience in a clinical trial environment;
Demonstrated experience with clinical trial management practices with knowledge of the 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 in remote clinical trial management preferred;
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;
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;
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;

External Referral Bonus:

Eligible

Potential for Telework:

Yes, 50%

Clearance Level Required:

Public Trust

Travel:

Yes, 25% of the time

Scheduled Weekly Hours:

Shift:

Day

Requisition Category:

Professional

Job Family:

Life Scientist

Pay Range:

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 38,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Va., Leidos reported annual revenues of approximately $11.09 billion for the fiscal year ended January 3, 2020. For more information, visit www.Leidos.com.

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.

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 spam.leidos@leidos.com.

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.