Clinical Trial Manager
Title: Clinical Trial Manager
Reports To: Vice President, Clinical Operations
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 lead by a highly experienced team of entrepreneurs with deep industry history and a long track record of achievement and success.
We are a fast-paced organization with multiple active trials ongoing. 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 hardworking team player, like the chance to have meaningful impact, and want to join a great team of industry veterans, we are excited to meet you.
Summary and Scope of Position:
Direct and coordinate the operational and logistical activities of all assigned clinical operations projects.
- Responsible for managing activities associated with the conduct and execution of assigned clinical trials.
- Evaluate, monitor and facilitate the flow of clinical data to ensure accuracy.
- Assist with the development of protocols.
- Develop and assist with the drafting of consent forms, monitoring plans, case report forms, and other clinical documents related to clinical trials.
- Manage investigational sites to ensure compliance with protocol 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.
- Assist with the negotiation of contracts and budgets with clinical investigational sites and other vendors.
- Supervise clinical site monitors (internal and/or contract).
- Assist in the development of investigator brochures and other regulatory documents.
- Participate in safety review and reporting; track subject enrollment and safety information for interim analysis.
- Assist with the selection and management of CROs and other consultants to ensure adherence to domestic and international regulations and standards (GCP, MDD, ICH).
- Work closely with CMC and Research departments to ensure adequate clinical and non-clinical supplies.
- Participate in the development and maintenance of clinical project timelines.
Additional Essential Functions:
- Lead internal study team meetings and update stakeholders on a regular basis of study timelines and activities.
- Work closely with the Medical Monitor to lead the planning and execution of successful Investigator meetings.
- Participate in preparation of Regulatory submissions as required.
- Participate in the review and update of existing procedures and develop new procedures as needed.
- Perform other related duties as required to support the Vice President or Director of Clinical Operations and 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 FDA and international regulatory requirements.
- 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.
- Able to work independently.
- Excellent time management skills (timelines, schedules, task prioritization).
- Willing and able to travel up to 30% of time.