and Purpose:

The Senior Monitor will be responsible for actively monitoring multiple clinical sites independently while overseeing and mentoring junior monitors. This role requires extensive experience in clinical trial monitoring, as well as the ability to manage smaller pilot studies autonomously. The Senior Monitor will also play a critical role in working with CROs to ensure seamless monitoring during pivotal phase field trials. Additional responsibilities include ensuring laboratory and clinical activities are performed in compliance with current scientific knowledge, quality and regulatory requirements and supporting other departments for technical processes and organization.

Responsibilities and Key Duties:

Clinical

·Organize, coordinate and lead the execution of pivotal and non-pivotal clinical studies

·Recruitment of clinical investigative sites

·Design electronic data capture (EDC) system to ensure high-quality trial data collection.

·May act as a study monitor

·Select and train clinical monitoring team (including CROs and laboratories if necessary) and implement adequate meetings while in life phase of pivotal studies are ongoing. Ensure monitoring team as well as clinical investigative sites remain compliant with study protocols and regulatory requirements.

·Support regulatory department in submission of documents/requests to FDA/CVM (including H-submissions, meeting requests, protocol submissions, SAE reporting, etc.)

Communication

·Independently source supplies in support of clinical studies.

·Interacts with external collaborators

·Maintain regular inter and intradepartmental communication in support of ongoing projects

·Present scientific literature for internal review

Scientific Writing/presentation

·Maintain high quality regulatory documentation

·Author and edit a variety of study documents, including, but not limited to, study protocol, protocol amendments, monitoring manual, data management plan, SOPs, training decks, etc.

·Review technical documents for accuracy of timelines, methods, and data sets

·Prepare presentation using Microsoft ® Powerpoint for internal sharing of data

Core Competencies:

● Shape solutions out of complexity - Is open and curious of others perspectives

● Client focus - Has in mind clients satisfaction

● Collaborate with empathy - Has a positive attitude towards collaboration

● Engage and develop - Clarifies short-term directions

● Drive ambition and accountability - Proactively manages own and others work

● Influence others - Communicates transparently

Technical / Functional Competencies:

·Expertise in clinical study design, EDC systems, GCP/VICH guidelines and regulatory compliance

·Ability to clearly and accurately write and present scientific information

·Ability to work in a team setting

·Proven ability to manage multi-site studies and oversee clinical monitoring staff

·Prior experience interfacing with CROs to ensure high-quality clinical monitoring performance

·Excellent problem-solving, leadership and communication skills

·Ability to travel as needed for site visits and regulatory meetings

Qualifications:

Education – BA/BS in Microbiology, Biology, or related field

Work Experience – 5+ years of relevant experience, or a graduate degree (MS or PhD) in a related field

Physical Requirements:

·Ability to read, write legibly, and communicate in English

Working Conditions:

·Ability to coordinate with multiple different departments across multiple time zones to ensure work is completed on time and with high levels of execution.

Travel Required:

·25%

This This job description is
intended to convey information essential to understanding the scope of the job
and general nature and level of work performed by job holders within this
job. This job description is not intended
to be an exhaustive list of qualifications, skills, duties and responsibilities
or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties
and/or job descriptions at any time to meet the needs of the business.

*VEVRAA Federal
Contractor

**Ceva is an equal opportunity
employer and all qualified applicants will be considered for employment without
regard to race, color, religion, sex, national origin, age, genetic
information, actual or perceived sexual orientation, gender identity, disability
status, protected veteran status, or any other characteristic protected by
law. Ceva encourages men and women, members of all racial and ethnic groups,
individuals with disabilities and veterans to apply.
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