Senior Clinical Trial Manager

IMMUNEERING CORPORATION•San Diego, CA

24d

About The Position

Senior Clinical Trial Manager is responsible for ensuring the quality of clinical trials and implementing and overseeing various projects. Senior Clinical Trial Manager collaborates with the designated CRO and vendors, as well as internal team across functions, and directs activities to execute and deliver the assigned studies. This role reports to the Director of Clinical Operations.

Requirements

B.S. (or higher) degree in a Science or related field required
Minimum 8 years of work experience for a pharmaceutical company or CRO
Minimum of 8 years of work experience in PM/CTM (or equivalent) roles on Oncology projects
Global multi-center trial experience is required
Demonstrated application and working knowledge of global GxP regulations for pharmaceutical industry (i.e., Good Clinical Practices, Good Lab Practices, current Good Manufacturing Practices, 21 CFR Part 11 Electronic Records; Electronic Signatures, MHRA/EMA/FDA regulatory body inspections)
Outstanding communication skills, both verbal and written
Proficient with Microsoft Office Word, Excel, PowerPoint, MS Project
Ability to work independently and prioritize duties
Understanding of Electronic Data Capture (EDC) and other clinical systems
Strong analytical and organization skills
Self-motivated and self-directed

Responsibilities

Acting as a primary liaison with the CRO/CROs on the assigned projects, including global multi-center trials.
Providing management and oversight for the CROs/vendors involved in the assigned projects ensuring on time and on budget delivery.
Partnering with other functions internally to achieve key milestones, optimize processes and achieve efficiencies.
Providing regular reporting on project metrics and serving as internal liaison at Immuneering, regarding all project related inquiries, presentations and updates
Creating and implementing study-specific clinical monitoring tools and documents in collaboration with CRO/vendors and internal team.
Identifying and choosing/approving sites and coordinating site startup activities.
Supervising and having regular meetings with the CRO and other clinical vendors involved in the projects
Reviewing the clinical trial agreements and budgets for the CRO, vendors and clinical sites
Overseeing the CRO’s contact with the study sites, including ordering/providing supplies and investigational product, and site management.
Ensuring inspection readiness and that all study activities are conducted in compliance with the protocol and procedures, GCP, FDA/EMA/local regulations, guidelines and policies.
Escalating issues as needed to the Sr Director, Clinical Operations with the proposed action plan
Participating in the development of SOPs, working guidelines, mentoring and educational activities
Managing task with minimal to no supervision