Job Description

This role will be key in developing internal Clinical Operations systems and procedures to improve all aspects of Clinical Study related business processes and will work very closely with the Associate Director of Clinical Operations along with the US Site Head.

Job Responsibilities:

• Participates in the planning, implementation and management of pre-IND through Phase I-II clinical trials, in collaboration with Contract Research Organization (CRO) partners, if applicable.
• Manage day to day activities of all aspects of clinical studies including study plans, timelines, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams.
• Contributes to development of RFPs and participates in selection of CROs/vendors.
• Manages CRO and vendor activities to ensure adherence to deliverables and timelines.
• Provides updates on project status and deliverables to Clinical Project Management leads (deliverables may include project status reports, vendor reports, trackers, meeting minutes/action items).
• Contributes to development of study budget(s).
• Maintains primary responsibility for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, safety plans, project management plans, communication plans, and quality plans, whether developed internally or externally.
• Oversees investigator recruitment/selection and the conduct of trials at investigative sites.
• Participate as necessary in monitoring visits (co-monitoring), reviews monitoring visit reports and ensures CRO quality within trials, if applicable.
• Plans, executes, and leads Investigators Meetings, if applicable.
• Contributes to development of internal Clinical Operations systems to improve business processes.
• Develops relationships with Key Opinion Leaders as applicable for key company development programs.
• Prepare and present study or project specific updates.
• Represent Project Management & Clinical Operations in partnered development programs.

Qualifications:

• Life sciences or medical background is required.
• 6+ years of industry experience (biotech/pharma) with at least 2-5 (will determine level) years of project management experience
• Experience in Phase 1 Oncology trials.
• Strong understanding of ICH, GCP and relevant regulatory requirements
• The ability to work with cross-functional teams in a matrix environment is a must;
• Strong organizational and time management skills; detailed oriented; excellent interpersonal and communication skills
• Proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project.
• Ability to travel domestically and/or globally 10% of the time.