At Enterin, we are pioneering the medical community’s understanding of the link between infections, dysfunction of the enteric nervous system (ENS) of the gut, and the early onset and chronic progression of neurodegenerative disease.
To apply for any of the career opportunities shown below, please send your resume and an optional cover letter to firstname.lastname@example.org. Please note in the Subject line for which position you are applying. We will try to respond to each applicant within a reasonable period of time, although please recognize that depending on the volume of applications, we may not be able to respond to each applicant. Thank you for your understanding and for your interest in working at Enterin.
Enterin is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Enterin does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Enterin from recruiters do not constitute any type of relationship between the recruiter and Enterin and do not obligate Enterin to pay fees if we hire from those resumes.
The Clinical Trial Manager will direct and coordinate the operational and logistical activities necessary for the initiation and completion of clinical trials on time and on budget
- Responsible for managing activities associated with the conduct of assigned clinical trials.
- Develop and assist with protocols, consent forms, monitoring plans, case report forms, and other clinical documents related to clinical trials.
- Manage investigational sites and/or CROs 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.
- Negotiate contracts and budgets with clinical investigational sites and other vendors.
- Supervise clinical site monitors (internal and/or contract).
- Select and manage CROs and other consultants and vendors to ensure adherence to domestic and international regulations and standards (GCP and ICH).
- Participate in the review and update of existing procedures and develop new procedures as needed.
- Develop and maintain clinical project timelines.
- Interface with other departments within the organization to exchange technical data and negotiate courses of action on behalf of Clinical Operations.
- Lead study team meetings and update project management on a weekly basis of study timelines and activities.
- Perform other related duties as required to support Clinical Operations and Enterin.
- BS or equivalent experience in a scientific or medical discipline with 5 -10 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 people, funding, materials and support to meet project goals and timelines.
- Previous budget and contract negotiation experience.
- Knowledge of GCP .
- Ability to pro-actively identify and solve problems that threaten timelines and successful completion of clinical trials.
- Able to work independently.
- Excellent time management skills (timelines, schedules, task prioritization).
- Willing and able to travel up to 30% of time.