Study Monitor, Clinical and Non-Clinical Studies job in Cambridge, USA

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Contract

Discipline: Clinical Evaluation

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Study Monitor for a global Pharmaceutical company located in Cambridge, MA. Successful candidate will coordinate Regulated (GLP) and Non- GLP nonclinical development studies at Contract Research Organizations (CROs)

Job Responsibilities:

Coordinate protocol review and dose selection meetings
Review study-related documents (protocols, amendments) for completeness, accuracy and consistency
Perform and document CRO site visits to monitor study performance
Coordinate activities collaborating with multiple departments (Pharmaceutical Sciences, DMPK, and QA, etc.)
Schedule, track, and monitor study progress
Schedule milestones of study activities such as peer reviews as well as corresponding reports from internal and external laboratories
Track reporting deliverables and graph real-time data
Maintain study correspondence for assigned studies
Ensure finalization of study reports to support regulatory submissions

Skills and Requirements:

BS desirable, in a scientific discipline and/or 5+ years of industry experience, working at a pharmaceutical company and/or CRO
Experience with the design and conduct of regulated nonclinical studies
Strong interpersonal and organizational skills
Experience in reviewing study data and reports
Candidate should be a self-starter, and able to work with minimal supervision to achieve objectives in a timely manner
Good working knowledge of FDA Good Laboratory Practice (GLP) Regulations as set forth in 21 CFR Part 58, OECD and ICH guidelines
Excellent communication skills and is able to effectively communicate both internally and externally in performing role as liaison between Company and CRO
Proficiency with Microsoft Word, Microsoft Excel, and other common electronic systems
AALAS certification desirable

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-NR1
#ClinicalResearch