Job Description

The Clinical Trial Manager/Senior Clinical Trial Manager will work closely with the rest of the Clinical and cross-functional team members to ensure successful execution of clinical trials. The CTM/Sr. CTM will be accountable for the day-to-day operational oversight of one or more clinical trials in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements.

Primary Responsibilities

Manage clinical trial operations including vendor performance, internal/external metrics, and communication of project status within the project team
Manage and track completion of study start-up, conduct, and closeout activities to industry and corporate standards
Ensure the progress and completion of projects according to timelines
Prepare and present project specific updates
Lead or assist in the writing of clinical documents such as protocols, study reports, study manuals, and annual reports
Monitor safety surveillance and reporting activities
Oversee data management processes including collection and cleaning of clinical database, reconciliation of clinical and safety databases, and data interpretation and evaluation
Coordinate DSMB/safety reviews in line with charter and overall study parameters
Assist in the construction of Clinical Operations processes and procedures, including development and writing of SOPs, creation and organization of study Trial Master Files, and clarification of organization and workflow structures
Plan, generate, and track study timelines and trial budgets
Site management activities including: review monitoring reports, interact with study monitors, track deviations or other indicators of site difficulties, identification of potential problem sites and development of corrective action plans as required, acting as Carmot contact, as needed, for clinical sites
Other duties as assigned

Required Experience and skills:

5+ years of clinical research in the biotechnology/pharmaceutical industry
3+ years of multi-center clinical trial management experience, specifically experience in Phase 2 and Phase 3 US and international clinical trials
Experience managing CROs, central laboratories, and other clinical study vendors
Experience preparing clinical trial protocols, budgets, and contracts
Experience in metabolic/hepatic drug development is desirable
Proficiency with MS Word, Excel, and PowerPoint is required
Proficiency with MS Project is preferred
Strong leadership and management skills
Excellent team work and collaboration skills
Outstanding written and verbal communication skills
Independent, innovative, and creative thinker
Expert knowledge of scientific principles and concepts
Ability to interpret and evaluate clinical data
High level organization and time management skills
Must be able to work in a fast-paced start-up environment with demonstrated ability to juggle multiple competing tasks and demands

Valid through: 4/26/2021