Clinical Trial Manager
This is a full-time position that will require work from the Emeryville office at least three days a week.
DermBiont, Inc. is a clinical-stage microbiome biotechnology company, pioneering a paradigm shifting approach to treat and prevent skin diseases and disorders.
DermBiont is primarily focused on rapidly advancing novel microbiome therapeutics to treat skin maladies.
We are led by a highly experienced team of entrepreneurs with deep industry history and a long track record of achievement and success.
DermBiont is a fast-paced organization with a start-up mentality and multiple active trials ongoing. We all move fast, work efficiently, and have a willingness to pitch-in and multi-task. This role will allow you to make a meaningful impact in our organization and allow you to collaborate on a team to change the dermatology industry with our game changing approach to skin disease.
If you are a hardworking, hands on team player, would like the chance to have a meaningful impact, want to join a great team of industry veterans, and don’t mind stepping in where you are needed to get the job done, we are excited to meet you.
Summary and Scope of Position:
Lead initiation, conduct, and steer completion of clinical trials. This is a hands-on position.
- Assist with the development of protocols as they relate to the operational aspects of the trial.
- Lead the creation of consent forms, monitoring plans, case report forms, source documents, and other clinical documents related to clinical trials.
- Review medical monitoring plan.
- Lead the selection and management of CROs and other consultants to ensure adherence to domestic and international regulations and standards (GCP, MDD, ICH).
- Assist with the negotiation of contracts and budgets with clinical investigational sites and other vendors.
- Participate in the development and maintenance of clinical project timelines.
- Work closely with CMC and Research departments to ensure adequate clinical and non-clinical supplies.
- Ensure compliance with protocols and overall clinical objectives; including traveling to sites to conduct pre-study, initiation, interim and closeout visits and/or co-monitor with CRO or contract associates.
- Organize and manage SIV’s.
- Supervise clinical site monitors (internal and/or contract).
- Assist the medical monitor in safety review and reporting.
Additional Essential Functions:
- Lead internal study team meetings.
- Work with project management to keep the project plan current.
- Work closely with the Medical Monitor to lead the planning and execution of successful Investigator meetings.
- Participate in preparation of Ethics Committee submissions as required.
- Perform other related duties as required to support the Clinical Operations Team and company goals.
- BS or equivalent experience in a scientific or medical discipline with 5 years clinical trials management experience.
- Experience managing external suppliers and/or working in a virtual environment (e.g., CROs and independent contractors).
- Previous management or project management experience with demonstrated leadership ability.
- Excellent communication; interpersonal skills and influencing skills
- Ability to determine the resources and support to meet project goals and timelines.
- Previous budget and contract negotiation experience.
- Knowledge of good clinical practices.
- Ability to leverage own expertise and input from others to identify issues and make recommendations that address overall corporate and program needs.
- Able to work in a fast-paced environment and multi-task.
- Able to work independently.
- Excellent time management skills (timelines, schedules, task prioritization).
- Willing and able to travel, including within the U.S. and internationally, including the Caribbean.