Clinical Trials Manager

ManagerManagerFull TimeRemoteTeam 10,001+Company Site LinkedIn

Location

United States

Posted

31 days ago

Salary

$133.2K - $172.4K / year

Bachelor Degree6 yrs expEnglish

Job Description

• Coordinating and supervising all aspects of a clinical study • Monitors clinical trial sites • Assists Clinical Program Manager in overall study management • Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports • Maintains study timelines • Contributes to development of study budget • Contributes to development of RFPs and participate in selection of CROs/vendors • Manage CROs/vendors • Coordinates review of data listings and preparation of interim/final clinical study reports • May contribute to development of abstracts, presentations, and manuscripts • Ensures effectiveness of site budget/contract process • May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.

Job Requirements

BS or BA in a relevant scientific discipline and 6 + years of relevant experience OR RN license (2 or 3 year certificate) and 6 + years of relevant experience
Excellent teamwork, communication, decision-making and organizational skills
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
Must be able to generally understand, interpret, and explain protocol requirements to others
Must be able to prioritize multiple tasks
May serve as a resource for others within the company for clinical trials management expertise.

Benefits

Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans