Orbis Clinical is seeking a remote-based Clinical Trial Manager for up until the end of the year.

Job Title: Clinical Trial Manager

Location: Remote

Contract: Up until the end of the year

Summary

The Clinical Trial Manager (CTM) is accountable for ensuring high quality deliverables are within timelines and budget. This position will work closely with cross-functional teams to ensure study start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials. 

Responsibilities

• Responsible for the day-to-day management of assigned operational aspects, such as CRO/vendor management, drug supply management, management of clinical sites, etc. for assigned region(s) or study(s)
• Manages high impact vendors, including oversight of timelines and contracts (invoicing, purchase order monitoring, and forecasting)
• Oversee development and maintenance of study documents such as Study Timelines, Vendor Management Plan, Risk Management Plan, Informed Consent Form, Monitoring Oversight Plan, CRFs, Study Reference Manual, dashboards, etc
• Lead, or actively contribute to, Study Management Team meetings
• Identify study risks, develop and implement mitigation strategies
• Oversee Trial Master File, Completeness Reviews, and Essential Document List
• Support the study budgeting process, including the review of invoices and clinical trial financial accruals
• Serve as a subject matter expert on initiatives and working groups
• Mentors Clinical Operations Staff (Clinical Trial Associates, Specialists, CTMs), including onboarding of new hires

Requirements

• Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
• Typically 6 years of direct work experience in Clinical Research, with international experience from study start up through closeout preferred
• Fully proficient in the management and execution of clinical trials
• Excellent planning, organizational, and communication skills
• Able to handle multiple tasks and deadlines; and identify risks and issues and take appropriate actions
• Must be self-motivated and able to develop solutions for a variety of complex problems where analysis requires an in-depth evaluation of variable factors, including inter-organizational impact
• Must have the ability to build and maintain positive relationships with management, peers, vendors, and clinical sites
• 10% travel may be required

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $71.72 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.