Position Summary: The Clinical Researcht Manager is responsible for the management of all aspects of Clinical Trial Team activities for assigned project(s). This one is a Global Phase 1b pivotal study. Reports directly to the Executive Director, Clinical (who reports to CMO). In concert with the ED, is accountable for achieving successful delivery of Company clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:
- Proactively help Study Start up and vendor management and Clinical Execution including management of trial timeline, budget, resources and vendors.
- Provide efficient updates on trial progress to the ED and Clinical Team, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
- This trial is a high profile trial out of the Cambridge, MA office but sites are in New Zealand and Australia (travel for Investigator meeting in middle 2020 is expected.)
- Show passion and enthusiasm to inspire and lead
- Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
- Ensure potential study risks are escalated to the attention of the ED, Clinical when appropriate.
First call with Executive Director, Clinical can provide more information (she, herself, is dynamic and energetic. The Clinical team is energetic and intelligent and I would love to share more details about the trials and high profile work they are known for. Also they have partnerships with Parker and Astra Zeneca and have been named the #1 company to watch in microbiome and c-diff breakthroughs.