Clinical Trial Manager
Eloxx Pharmaceuticals, Inc. (http://www.eloxxpharma.com/ ) is a clinical-stage biopharmaceutical company developing novel small molecule medicines to treat many rare and ultra-rare genetic diseases caused by nonsense mutations. Nonsense mutations are a class of genetic defects that result in premature termination of protein synthesis. These nonsense mutations have been identified in over 2,000 rare and ultra-rare diseases. As a consequence, patients with a genetic disease caused by nonsense mutations have absent or truncated nonfunctional proteins, accounting for some of the most severe phenotypes in these genetic diseases. Eloxx’s lead product candidate, ELX-02, is an investigational, novel translational read-through inducing drug designed to restore synthesis of full-length functional proteins. ELX-02 is an investigational agent undergoing clinical trials and has not been approved by any global regulatory body. Eloxx was founded in 2013 and is headquartered in Waltham, MA. with R&D operations in Rehovot, Israel.
This is an opportunity to join a growing and energetic team, build a high performing company, gain personal development and transform patient lives.
Manages overall operational implementation of the clinical project to execute on the study and scientific plan and ensure overall quality over the life of a study. Develops study specific tools and documents, and provides overall direction for the clinical sites and to study team members. Ensures compliance with all global regulations and regulatory guidelines. Recommends and implements innovative process ideas to positively impact clinical trials management. May develop and manage clinical budget and develop contingency plans for clinical trials. Supervises clinical trials staff and provides training and mentorship. Responsible for managing and tracking full scope of study. Acts as a cross functional liaison to ensure implementation of discreet trial tasks.
Essential Job Responsibilities
- Primary contact for study team members and external vendors -delegates as appropriate
- Manages the process of writing, revising and tracking protocols and amendments to ensure adherence to regulations, company SOPs and processes, and ensures consistency across clinical trials.
- Manage the development, revision and tracking of all study documents including informed consent and privacy authorization templates, case report forms and completion guidelines, and study specific instructions across clinical trials
- Reviews study specific documents in collaboration with the cross functional project team, and ensures consistency with the protocol and company SOPs and policies
- Evaluates and recommends selection of investigative sites and makes resource requirement recommendations.
- BA, BS or BSN within a scientific discipline
- 8-10 years of pharmaceutical experience.
- Ability to manager vendors and or third parties
- Ability to travel 20%
Interested candidates can click "Apply now"