Manage execution of clinical studies and data collection
Provide oversight of clinical research studies across all functional areas of drug development
Develop subject recruitment/retention strategy and related initiatives
Oversight of TMF setup, ongoing quality review, and final reconciliation of study documents
Develop training materials for study team, investigational sites, and vendors
Proactive management of information sharing with key stakeholders
Ensure compliance with ICH/GCP and other regulations
Collaborate with counsel to negotiate and draft research contracts and agreements
Perform study risk management and implement mitigations
Create realistic plans that define goals, milestones, responsibilities, and results
Manage daily activities and development of direct reports

Requirements

Bachelor’s degree required, preferably in scientific discipline
Minimum of 7 years of prior clinical operations experience preferably with CRO/small biotech experience
2 years of experience in a supervisory role
Experience in early phase studies preferred
Computer skills including proficiency with Microsoft Office suite of software, electronic TMF systems, document repository, CTMS, IRT, and EDC systems
Excellent understanding of drug development process
Ability to handle multiple tasks to meet deadlines in a dynamic environment

Benefits

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical studies managementdata collectionsubject recruitment strategyTMF setupquality reviewrisk managementdrug development processsupervisory experienceearly phase studies

Soft Skills

proactive managementinformation sharingcollaborationtraining developmentgoal settingmilestone planningresponsibility assignmentresults orientationmultitaskingdeadline management