Clinical Trial Manager - Cambridge, MA | Biospace
Get Our FREE Industry eNewsletter

Clinical Trial Manager

Jounce Therapeutics

Apply
Location:
Cambridge, MA
Posted Date:
4/20/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Clinical Trial Manager (CTM) will work collaboratively with the Lead Clinical Trial Manager to drive ongoing clinical studies. The CTM will also independently organize and manage multiple activities related to clinical studies, while simultaneously ensuring study milestones are met and studies are completed in accordance with the protocol. Future growth opportunities would include independently managing small studies of basic to moderate complexity or defined activities in more complex, multicenter studies (e.g., managing vendors).

Requirements

KEY RESPONSIBILITIES:

Directly oversees selected vendor(s) to ensure compliance with the contract specifications and applicable SOPs
Ensures accurate, timely, and complete tracking of laboratory samples
Applies thorough knowledge of GCP/regulatory requirements to all aspects of the study
Prepares all external and internal documentation for assigned trials ensuring it is completed in accordance with the study protocol, internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Monitoring Plans, Project Plans)
Works with the Lead CTM to develop and maintain study timelines
Oversees clinical site monitoring activities and co-monitors as needed
Conducts training regarding the operational aspects of the clinical trial including protocol, lab manuals, etc. to both internal team members and clinical site staff
Provide period quality control of the Trial Master File
May represent Clinical Operations in cross-functional initiatives
Performs other duties as assigned
TECHNICAL AND COMMUNICATIVE SKILLS:

Displays project management skills to projects and/or activities with assistance from Senior Clinical Operations staff
Demonstrates ability to communicate and coordinate activities with the internal team, clinical sites and vendors
Able to proactively identify project challenges/risks and implement appropriate actions with some supervision
Effectively organizes cross functional team (primarily internal to Jounce)
Strong communication (written and verbal) skills
Demonstrated computer skills; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant Jounce systems and programs
PREFERRED EDUCATION AND EXPERIENCE:

B.S. (or equivalent experience) and 3 – 6 years of relevant work experience
M.S. (or equivalent experience) and 2 – 4 years of relevant work experience