Clinical Program Manager

Axle•Rockville, MD

3d•$100,000 - $110,000•Onsite

About The Position

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Axle is seeking a Clinical Program Manager to join our vibrant team at the National Institutes of Health (NIH) supporting the National Cancer Institute (NCI) located in Rockville, MD. This position will independently provide support services to satisfy the overall operational objectives of the NCI/DCTD.

Requirements

Clinical trial project management experience.
Previous project management experience and/or clinical trial management including data management.
Proficiency in using Microsoft software applications (Windows, Word, Excel and PowerPoint).
Strong communications skills, both oral and written.
Excellent analytical, organizational and time management skills.
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.

Nice To Haves

Familiarity with area of clinical trials preferably in the field of Oncology

Responsibilities

Provide scientific and administrative project management support.
Develop a new tracking and reporting system for the Biomarkers and Medical tests funding sources.
Generate appropriate SOPs and workflows for the new processes.
Monitor LOIs and protocols to make an early determination of associated correlative work funding mechanism (CRADA, MoCha, NCLN, grants, etc.).
Collaborate with internal and external stakeholders for intellectual property requirements, CRADAs, MTAs, etc.
Reviews, assesses and evaluates clinical trial design and feasibility.
Reviews, evaluates and analyzes clinical trial data and study information.
Reviews, evaluates and recommends logistical, procedural and operational approaches to clinical trial implementation.
Assesses and supports meetings, clinical trial assessments and site visits.
Formulates guiding principles and Standard Operating Procedures (SOPs) and prepares staff for clinical research.
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 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.
Provide 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.
Create 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.