Support all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out.
Collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director.
Direct and complete communication between the project team and site personnel to ensure appropriate training, understanding of project requirements, and milestones.
Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites.
Initiate and build professional relationships with clinical site staff.
Partner with the CRO to ensure robust ongoing data monitoring strategies.
Creation and development of study trackers.
Develop and provide clear, complete documentation of study-specific meetings and action items.
Responsible for the development and management of clinical trial documents.
Ensure compliance of clinical trials with national regulatory requirements and company SOPs.
Provide close oversight on findings from monitoring reports and communicate updates as needed.

Requirements

Bachelors degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
A minimum of 3+ years of clinical research experience in conducting clinical trials
Prior phase II or III experience required
A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP, and each step within the clinical trial process
Experience with clinical studies in oncology and/or rare diseases is a plus
Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams
Ability to travel internationally to visit clinical sites and for study meetings (up to 20%)
Excellent interpersonal and decision-making skills.
Excellent written and oral communication skills.

Benefits

Compensation packages based on skill set, experience, certifications, and location.
Total compensation may include bonus, stock, benefits, and variable compensation.

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical trial managementclinical researchstudy planningdata monitoringstudy trackersclinical trial documentsrecruitment methodsdrug development processICH guidelinesGCP

Soft Skills

interpersonal skillsdecision-making skillscommunication skills