Position Objective: The Clinical Program Manager will provide support services to satisfy the overall operational objectives of the National Cancer Institute within the National Institutes of Health.
Duties and Responsibilities:
- Provide scientific and administrative project management support. 1
- Develop a new tracking and reporting system for the Biomarkers and Medical tests funding sources. 2
- Generate appropriate SOPs and workflows for the new processes. 3
- Monitor LOIs and protocols to make an early determination of associated correlative work funding mechanism (CRADA, MoCha, NCLN, grants, etc.). 4
- Collaborate with internal and external stakeholders for intellectual property requirements, CRADAs, MTAs, etc. 5
- Provide scientific and administrative project management support.
- Generate appropriate SOPs and workflows for the new processes.
- Work products and documents related to providing scientific and administrative project management support; work with CTEP and contracting project management staff to ensure the operational needs of the project are being met; collaborate with CTEP IDB, CDP and RAB staff to ensure associated correlative work is identified.
- Work products and documents related to developing a new tracking and reporting system for the Biomarkers and Medical tests funding sources; monitor LOIs and protocols to make an early determination of associated correlative work funding mechanism (CRADA, MoCha, NCLN, grants, etc.)
- Work products and documents related to providing support for the drafting and negotiation of Cooperative Research and Developments Agreements for NCI scientists and their industrial/academic research partners; ensure that agreements in the MATCH program are consistent with existing agreement and NCI/NIH policy.
- Work products and documents related to creating data/ monitoring plans and providing regular written reports detailing progress against tasks and milestones; maintain the "Active Agreements" list on the CTEP Website of current CTEP Agents available for request; maintain the ACG SharePoint Page as requested.
Basic Qualifications:
- Master's degree in Biology or similar field of study.
- Clinical trial project management experience.
- Previous project management experience and/or clinical trial management including data management.
- Ability to do work assignments and/or projects successfully and completed in a timely manner.
- Ability to work in a busy setting, both independently and within a team.
- Familiarity with area of clinical trials preferably in the field of Oncology
- Proficiency in using Microsoft Office Suite
Preferred Qualifications:
- Ability to communicate effectively, orally and in writing, with non-technical and technical staff
- Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
- This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.
This position is contingent upon contract award.