Discovering drugs for endocrine diseases and endocrine-related tumors. #acromegaly #crinetics #CarcinoidSyndrome

Senior Manager, Clinical Monitoring

ManagerManagerFull TimeRemoteTeam 201-500Since 2015H1B No SponsorCompany Site LinkedIn

Location

California

Posted

33 days ago

Salary

$136K - $170K / year

Bachelor Degree8 yrs expEnglish

Job Description

• Supports global and regional Clinical Trial Operations (CTO) and Clinical Monitoring management • Manage Clinical Research Associates (CRA) and lead the development of processes, procedures, and tools/templates related to monitoring and site management activities • Develop and implement strategy for in-house, regional monitoring activities on assigned studies • Lead monitoring activities on assigned studies • Author or review Clinical Monitoring Plan in collaboration with CTO and ensure CRA compliance • Manage the CRA monitoring visit schedule • Review and finalize visit reports for regional CRAs • Track status of action items and queries • Support CRAs and CTO with the implementation of site corrective actions • Track and report to study team and leaders on compliance, trends, and metrics • Manage conduct of monitoring oversight visits (MOVs) with CRO CRAs • Mentor Associate Managers and Managers of Clinical Monitoring • Conduct annual performance assessment activities including appraisals, salary recommendations, and promotion justifications • Lead development and improvement of department processes, best practices, and tools and templates

Job Requirements

BS in biological sciences or related discipline
at least 8 years of experience working in the biotechnology/pharmaceutical industry
Experience in endocrine disorders preferred
A minimum of 5 years in a supervisory role
Strong understanding of clinical trial processes, protocols, and medical terminology
experience using risk-based monitoring processes strongly preferred
Previous experience as a Lead CRA, Trial Manager, or equivalent strongly preferred
Demonstrates critical thinking, root cause analysis and problem solving
An understanding and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements
In-depth experience with cross-functional drug development with prior regulatory inspection experience preferred
Excellent writing skills as they relate to the preparation of clinical trial documents
Excellent interpersonal skills with strong oral/written communication and presentation skills
Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved
Demonstrated leadership and management skills
Good judge of risks and a keen ability to analyze options and manage outcomes
Well-versed with the latest trends in the clinical trial industry.

Benefits

health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
winter company shutdown
discretionary annual target bonus
stock options
ESPP
401k match