Position Overview: Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and external stakeholders and be the primary driver of all clinical study related activities, timelines, actions and plans. This individual will be hands on with trial sites fostering relationship development with KOLs. This is a high visibility position with great impact potential.
Key Responsibilities:
- Responsible for engaging third party vendors and managing the RFP process from vendor identification through bid defense and contracting
- Accountable for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget
- Facilitate dose escalation meetings and the associated content and documentation enabling them
- Assist with the drafting of protocols, informed consent forms, study operations guidelines and other study plans
- Work with finance to reconcile monthly actual and forecast budgets
- Oversee maintenance of the eTMF
- Perform co-monitoring visits of clinical study sites
- Plan and coordinate advisory boards, investigator meetings and CRA trainings
- Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress
- Maintain a high standard of professionalism, and confidentiality be able to problem solve, communicate effectively, and trouble-shoot creatively
Minimum Qualifications:
- BS/BA/BSN – health/science related field preferred
- Minimum 3-5 years’ relevant industry experience including at least 2 years of trial management experience
- Excellent communication, writing and presentation skills
- Demonstrated ability to work independently as well as in a team environment and seek resources as necessary
- Ability to assess complex issues and propose viable solutions
- Demonstrated ability to lead and organize team meetings
- Ability to foster effective relationships with vendors, investigators and colleagues
- Ability to contribute technical expertise to the various aspects of the clinical trial process.
- Proficiency in study monitoring activities
- Knowledge of the infrastructure and operational characteristics of CROs and centralized services.
- Demonstrated effective time management skills
- Must be willing to travel domestically and internationally up to 15-20%
Preferred Qualifications
- MS or advanced degree
- 6 or more years in a Clinical Operations Management role
- Global trial management experience
- Prior Clinical Monitoring and/or CRO experience
- Knowledge of First in Human trial management
- Experience with dermatology indications
