Clinical Program Manager

This position will independently provide support services to satisfy the overall operational objectives of the NCI/DCTD.

• Clinical trial project management experience.

• Previous project management experience and/or clinical trial management including data management.

• Biology

• 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.

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

• 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. - Ad-Hoc

• 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.) - Ad-Hoc

• 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. - Ad-Hoc

• 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. - Ad-Hoc

• 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

• 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.